Efficacy And Safety Of Pregabalin For Pain Following Total Knee Replacement
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00442546
Collaborator
(none)
307
27
3
19.1
11.4
0.6
Study Details
Study Description
Brief Summary
Pregabalin added to the standard of care with dosing starting preoperatively and continuing for up to 6 weeks post surgery will decrease the intensity of post-operative pain following total knee replacement.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
307 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Multicenter, Double-Blind Randomized, Placebo-Controlled Study Of The Efficacy And Safety Of Pregabalin In The Treatment Of Subjects With Post-Operative Pain Following Total Knee Arthroplasty (TKA)
Study Start Date
:
May 1, 2007
Actual Primary Completion Date
:
Dec 1, 2008
Actual Study Completion Date
:
Dec 1, 2008
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1
|
Drug: pregabalin
150 milligram (mg)/ day (double blind)
|
| Experimental: 2
|
Drug: pregabalin
300 mg/day (double blind)
|
| Placebo Comparator: 3
|
Drug: Placebo
Placebo
|
Outcome Measures
Primary Outcome Measures
- Subject Reported Worst Pain Score in Daily Diaries Using the Worst Pain Item of the Modified Brief Pain Inventory - Short Form (m-BPI-sf) [48 hours after surgery]
The mBPI-SF is a self administered questionnaire developed to assess pain severity and pain interference with functional activities during a 24-hour period prior to evaluation. For the Worst Pain item of the m-BPI-sf scale (11 point Likert scale; range: 0 [no pain] to 10 [pain as bad as you can imagine]), subjects were asked to rate their pain by marking an "X" in one of the ten boxes that best described their pain at its worst in the last 24 hours post surgery and at least 12 hours after discontinuation of the peripheral nerve block or neuroaxial block.
Secondary Outcome Measures
- Cumulative Total Amount of Opioids Used During the Entire Hospital Stay [24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours, 168 hours, 192 hours, 216 hours]
Total cumulative dose calculated as mg of oral morphine equivalent and included opioids given by any route (patient controlled analgesia [PCA] pump, parenteral bolus or oral). Results for daily total not including pregabalin (not an opioid). Statistical model included main effect of treatment group and center. 1 subject at 144 h, 300 mg=non-missing data. Due to small sample size (N=1, 300 mg; N=5, other groups) and large opioid consumption for another subject in same center, least squares mean (300 mg, 144 h) is negative.
- Opioids Used Post Discharge [Week 2, Week 4, Week 6/Early Termination (ET)]
The amount of opioid use was calculated as mg of oral morphine equivalent and included opioids administered by any route (PCA pump, parenteral bolus, or oral). Weeks 2, 4, and 6 total daily doses were calculated by adding the cumulative doses during the 2 week period prior to the visit and dividing them by the number of days in the period. This outcome measure does not include pregabalin as it is not an opioid.
- Analgesics Used During the Hospital Stay (Acetylsalicylic Acid, Ketorolac, and Paracetamol) [24 hours, 48 hours, 72 hours]
Total dose for in-hospital visits was the total dose for the day.
- Analgesics Used Post Discharge (Acetylsalicylic Acid [Week 2] and Paracetamol [Weeks 2, 4, and 6] [Week 2, Week 4, Week 6/ET]
Weeks 2, 4, and 6 total daily doses were calculated by adding the cumulative doses during the 2 week period prior to the visit and dividing them by the number of days in the period.
- Analgesics Used Post Discharge (Ibuprofen) for the Pregabalin 150 mg and Placebo Treatment Groups [Week 2, Week 4, Week 6/ET]
Weeks 2, 4, and 6 total daily doses were calculated by adding the cumulative doses during the 2 week period prior to the visit and dividing them by the number of days in the period.
- Analgesics Used Post Discharge (Ibuprofen) for the Pregabalin 300 mg Treatment Group [Week 2, Week 4, Week 6/ET]
Weeks 2, 4, and 6 total daily doses were calculated by adding the cumulative doses during the 2 week period prior to the visit and dividing them by the number of days in the period.
- Analgesics Used Post Discharge (Acetylsalicylic Acid) for the Pregabalin 150 mg and Placebo Treatment Groups at Week 4 [Week 4]
Week 4 total daily dose was calculated by adding the cumulative doses during the 2 week period prior to the visit and dividing them by the number of days in the period.
- Analgesics Used Post Discharge (Acetylsalicylic Acid) for the Pregabalin 300 mg Treatment Group at Week 4 [Week 4]
Week 4 total daily dose was calculated by adding the cumulative doses during the 2 week period prior to the visit and dividing them by the number of days in the period.
- Analgesics Used Post Discharge (Acetylsalicylic Acid) for the Pregabalin 150 mg and Placebo Treatment Groups at Week 6/ET [Week 6/ET]
Week 6 total daily dose was calculated by adding the cumulative doses during the 2 week period prior to the visit and dividing them by the number of days in the period.
- Analgesics Used Post Discharge (Acetylsalicylic Acid) for the Pregabalin 300 mg and Placebo Treatment Groups at Week 6/ET [Week 6/ET]
Week 6 total daily dose was calculated by adding the cumulative doses during the 2 week period prior to the visit and dividing them by the number of days in the period.
- The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the Opioid-Related Symptom Distress Scale (OR-SDS) - Frequency Composite Score [24 hours, 48 hours, 72 hours, 96 hours, 120 hours, Discharge, Week 2, Week 4, Week 6/ET]
The OR-SDS was used to assess subject-reported levels of frequency concerning 10 symptoms known to be associated with opioid medication usage: fatigue, drowsiness, inability to concentrate, nausea, dizziness, constipation, itching, difficulty with urination, confusion, and retching/vomiting. Symptom frequency was rated as: 1=rarely, 2=occasionally, 3=frequently, or 4=almost constantly. The average score for each symptom was calculated by taking the mean of patient-reported score. Total possible frequency score: 0 (less frequent) to 4 (more frequent).
- The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Severity Composite Score [24 hours, 48 hours, 72 hours, 96 hours, 120 hours, Discharge, Week 2, Week 4, Week 6/ET]
The OR-SDS was used to assess subject-reported levels of severity concerning 10 symptoms known to be associated with opioid medication usage: fatigue, drowsiness, inability to concentrate, nausea, dizziness, constipation, itching, difficulty with urination, confusion, and retching/vomiting. Symptom severity was rated as: 1=slight, 2=moderate, 3=severe, or 4=very severe. The average score for each symptom was calculated by taking the mean of patient-reported score. Total possible severity score: 0 (less severe) to 4 (more severe).
- The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Degree of Bother Composite Score [24 hours, 48 hours, 72 hours, 96 hours, 120 hours, Discharge, Week 2, Week 4, Week 6/ET]
The OR-SDS was used to assess subject-reported level of degree of bother concerning 10 symptoms known to be associated with opioid medication usage: fatigue, drowsiness, inability to concentrate, nausea, dizziness, constipation, itching, difficulty with urination, confusion, and retching/vomiting. Symptom degree of bother was rated as: 1=not at all, 2=a little bit, 3=somewhat, 4=quite a bit, or 5=very much. Average score for each symptom was calculated by taking the mean of patient-reported score. Total possible degree of bother score: 0 (less degree of bother) to 5 (greater degree of bother).
- The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Overall Composite Score [24 hours, 48 hours, 72 hours, 96 hours, 120 hours, Discharge, Week 2, Week 4, Week 6/ET]
The OR-SDS assessed subject-reported levels of frequency, severity and degree of bother for 10 symptoms known to be associated with opioid medication usage: fatigue, drowsiness, inability to concentrate, nausea, dizziness, constipation, itching, difficulty with urination, confusion, retching and vomiting. The overall composite score was the average across frequency, severity, and degree of bother scores. Total possible score: 0 (better) to 4.34 (worse).
- Total Clinically Meaningful Event (CME) Score [24 hours, 48 hours, 72 hours, 96 hours, 120 hours, Discharge, Week 2, Week 4, and Week 6/ET]
CMEs were defined using OR-SDS (assesses subject-reported levels of severity concerning 10 symptoms associated with opioid medication usage: fatigue, drowsiness, inability to concentrate, nausea, dizziness, constipation, itching, difficulty with urination, confusion and retching/vomiting). CME = any symptom rated as severe or very severe, with the exception of confusion. Confusion was defined as a CME if the severity score was at least moderate. Total score = the sum of CMEs across symptoms. Each CME = 1 point. Total CME score ranges from 0 to 9.
- Pain Interference Index Score as Measured by the m-BPI-sf [Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6]
m-BPI-sf questionnaire (7-items) assessed pain interference with functional activities during the past 24 hours. Pain interference index = average of pain interference question (Q) 5A to 5G. Questions were asked as follows: how, during the past 24 hours, has pain interfered with general activity (Q5A), mood (Q5B), walking ability (Q5C), normal work (outside home and housework) (Q5D), relations with other people (Q5E), sleep (Q5F), enjoyment of life (Q5G). Scale: 0=does not interfere to 10=completely interferes.
- Pain Interference With Relations With People as Measured by the m-BPI-sf [Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6]
m-BPI-sf questionnaire (7-items) assessed pain interference with functional activities during the past 24 hours. Q5E: Subject response to 'how, during the past 24 hours, pain has interfered with your relations with other people'. Scale: 0 = does not interfere to 10 = completely interferes.
- Pain Interference With Enjoyment of Life as Measured by the m-BPI-sf [Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6]
m-BPI-sf questionnaire (7-items) assessed pain interference with functional activities during the past 24 hours. Q5G: Subject response to 'how, during the past 24 hours, pain has interfered with your enjoyment of life'. Scale: 0 = does not interfere to 10 = completely interferes.
- Pain Interference With General Activity as Measured by the m-BPI-sf [Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6]
m-BPI-sf questionnaire (7-items) assessed pain interference with functional activities during the past 24 hours. Q5A: Subject response to 'how, during the past 24 hours, pain has interfered with your general activity. Scale: 0 = does not interfere to 10 = completely interferes.
- Pain Interference With Mood as Measured by the m-BPI-sf [Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6]
m-BPI-sf questionnaire (7-items) assessed pain interference with functional activities during the past 24 hours. Q5B: Subject response to 'how, during the past 24 hours, pain has interfered with your mood'. Scale: 0 = does not interfere to 10 = completely interferes.
- Pain Interference With Walking Ability as Measured by the m-BPI-sf [Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6]
m-BPI-sf questionnaire (7-items) assessed pain interference with functional activities during the past 24 hours. Q5C: Subject response to 'how, during the past 24 hours, pain has interfered with your walking ability'. Scale: 0 = does not interfere to 10 = completely interferes.
- Pain Interference With Normal Work as Measured by the m-BPI-sf [Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6]
m-BPI-sf questionnaire (7-items) assessed pain interference with functional activities during the past 24 hours. Q5D: Subject response to 'how, during the past 24 hours, pain has interfered with your normal work (work outside the home and housework)'. Scale: 0 = does not interfere to 10 = completely interferes.
- Pain Interference With Sleep as Measured by the m-BPI-sf [Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6]
m-BPI-sf questionnaire (7-items) assessed pain interference with functional activities during the past 24 hours. Q5F: Subject response to 'how, during the past 24 hours, pain has interfered with your sleep'. Scale: 0 = does not interfere to 10 = completely interferes.
- Daily and Weekly Worst Pain During the Hospital Stay and Post Discharge Assessed by the Pain Numerical Rating Scale (NRS) [12 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours, 168 hours, and 192 hours during the hospital stay, Week 2, Week 4, Week 6/ET]
Subject rated scale for worst pain over the last 24 hours. Scores ranged from 0 (no pain) to 10 (pain as bad as you can imagine). Weekly mean scores were calculated post-discharge.
- Daily and Weekly Average Pain During the Hospital Stay and Post Discharge Assessed by the Pain NRS [12 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours, 168 hours, and 192 hours during the hospital stay, Week 2, Week 4, Week 6/ET]
Subject rated scale for average pain intensity over the last 24 hours. Scores range from 0 (no pain) to 10 (pain as bad as you can imagine). Weekly mean scores were calculated post-discharge.
- Current Pain During the Hospital Stay Assessed by the Pain NRS [4, 8, 12, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, 104, 112, 120, 128, 136, 144, 152, 160, 168, 176, 184, and 192 hours during the hospital stay]
Subject rated scale for average pain intensity over the last 24 hours. Pain was assessed using the question "How much pain do you have right now?" Scores range from 0 (no pain) to 10 (most possible pain).
- Pain-Related Sleep Interference Post Surgery [24 hours, 48 hours, 72 hours, 96 hours 120 hours, 144 hours, 168 hours, and 192 hours post-surgery, Week 2, Week 4, Week 6/ET]
The NRS-Sleep: subject rated 11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]) rating how pain has interfered with sleep during the past 24 hours. Weekly mean scores were calculated post hospital discharge.
- Change From Baseline in Visual Analogue Scale for Anxiety (VAS-Anxiety) Score Prior to Surgery [Day 1, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, and 6 hours prior to surgery]
VAS-Anxiety was administered to measure pre-operative anxiety. Score: 0 = no anxiety to 100 = worst imaginable anxiety.
- Timed Up-and-Go (TUG) [24 hours, 48 hours, 72 hours, 96 hours, 120 hours, Week 2, Week 4, Week 6/ET]
TUG: time taken in seconds to rise from a standard arm chair, walk to a line on the floor 3 meters away, turn, return and sit down again.
- Range of Motion (ROM) Assessment of the Active Flexion of the Surgical Knee [24 hours, 48 hours, 72 hours, 96 hours, and 120 hours post surgery, Week 2, Week 4, Week 6/ET]
The degree of active (patient moving the knee) knee flexion and extension tolerated by each subject was recorded. Active ROM in the sitting position was assessed with a goniometer.
- ROM Assessment of the Passive Flexion of the Surgical Knee [24 hours, 48 hours, 72 hours, 96 hours, and 120 hours post surgery, Week 2, Week 4, Week 6/ET]
The degree of passive (movement of the knee with the aid of physical therapist or designee) knee flexion and extension tolerated by each subject was recorded. Passive ROM in the sitting position was assessed with a goniometer.
- Time From End of Surgery to Meet Hospital Discharge Criteria [time from end of surgery up to 192 hours post surgery]
The analysis was performed by Kaplan-Meier method with log-rank test.
- Time From End of Surgery to Actual Discharge [time from end of surgery up to 192 hours post surgery]
The analysis was performed by Kaplan-Meier method with log-rank test.
- Satisfaction With Current Pain Medication Measured by the Pain Treatment Satisfaction Scale (PTSS) [Discharge, Week 2, Week 4, Week 6/ET]
Measure of subject satisfaction with treatment for acute or chronic pain. Response range: 1 (strongly agree) to 5 (strongly disagree). Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment.
- Satisfaction With Medication Characteristics Measured by the PTSS [Discharge, Week 2, Week 4, Week 6/ET]
Measure of subject satisfaction with treatment for acute or chronic pain. Response range: 1 (strongly agree) to 5 (strongly disagree). Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment.
- Satisfaction With Medication Efficacy Measured by the PTSS [Discharge, Week 2, Week 4, Week 6/ET]
Measure of subject satisfaction with treatment for acute or chronic pain. Response range: 1 (strongly agree) to 5 (strongly disagree). Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment.
- Overall Satisfaction Measured by the PTSS [Discharge, Week 2, Week 4, and Week 6/ET]
Measure of subject satisfaction with treatment for acute or chronic pain. Response range: 1 (strongly agree) to 5 (strongly disagree). Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment.
- Overall Pain Relief Measured by the PTSS [Discharge, Week 2, Week 4, and Week 6/ET]
Measure of subject satisfaction with treatment for acute or chronic pain. Response range: 1 (strongly agree) to 5 (strongly disagree). Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment.
- Number of Subjects With Global Evaluation of Study Medication Scores [Discharge, Week 2, Week 4, and Week 6/ET]
The Global Evaluation of Study Medication is a subject-administered single item instrument that records the subject's overall impression (global evaluation) of the study medication by asking the following question: how would you rate the study medication you received for pain? The subject chooses based on a scale of 1 (poor), 2 (fair), 3 (good), or 4 (excellent).
- Number of Subjects With Persistent Pain Based on 11-Point Verbal Rating Scale (VRS) [Month 3, Month 6 (phone call)]
The presence of persistent pain was evaluated on the 11-point VRS. The subject answered the question: how much pain did you experience in the last 24 hours in your operated knee? A zero score of VRS was the only number considered as a "no." Any positive score (1-10) of VRS was consider as "yes."
- Neuropathic Pain Symptom Inventory (NPSI) [Month 3, Month 6 (phone call)]
NPSI: subject rated questionnaire to evaluate 5 dimensions of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia). Includes 10 descriptors ranging from 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each relevant dimension. Total score is calculated as the sum of scores of the 10 descriptors, range: 0-100. Higher score indicates greater intensity of pain.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Subjects with osteoarthritis (OA) undergoing elective TKA under regional anesthesia (neuroaxial with or without peripheral nerve block).
-
Subjects able to demonstrate sufficient psychomotor dexterity and cognitive capacity to use Patient Controlled Analgesia/Patient Controlled Epidural Analgesia if used as part of the standard of care.
-
The subject's preoperative health is graded as American Society of Anesthesiology Class 1 to Class 3
Exclusion Criteria:
-
Subjects undergoing revision, unicompartmental, bilateral total knee arthroplasty or subjects with planned second knee total knee arthroplasty at time of present procedure.
-
Subjects with inflammatory arthritides (i.e., rheumatoid arthritis, lupus, ankylosing spondylitis, psoriatic arthritis); Lyme disease.
-
Subjects with fibromyalgia and or other chronic pain syndromes
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pfizer Investigational Site | Northport | Alabama | United States | 35476 |
| 2 | Pfizer Investigational Site | Tuscaloosa | Alabama | United States | 35401 |
| 3 | Pfizer Investigational Site | Tuscaloosa | Alabama | United States | 35406 |
| 4 | Pfizer Investigational Site | Phoenix | Arizona | United States | 85023 |
| 5 | Pfizer Investigational Site | Little Rock | Arkansas | United States | 72205 |
| 6 | Pfizer Investigational Site | Miami | Florida | United States | 331036 |
| 7 | Pfizer Investigational Site | Vero Beach | Florida | United States | 32960 |
| 8 | Pfizer Investigational Site | Chicago | Illinois | United States | 60612 |
| 9 | Pfizer Investigational Site | Galesburg | Illinois | United States | 61401 |
| 10 | Pfizer Investigational Site | Lafayette | Louisiana | United States | 70503 |
| 11 | Pfizer Investigational Site | New Iberia | Louisiana | United States | 70563 |
| 12 | Pfizer Investigational Site | Baltimore | Maryland | United States | 21218 |
| 13 | Pfizer Investigational Site | Egg Harbor Township | New Jersey | United States | 08234 |
| 14 | Pfizer Investigational Site | Pomona | New Jersey | United States | 08205 |
| 15 | Pfizer Investigational Site | Voorhees | New Jersey | United States | 08043 |
| 16 | Pfizer Investigational Site | New York | New York | United States | 10021 |
| 17 | Pfizer Investigational Site | Charlotte | North Carolina | United States | 28207 |
| 18 | Pfizer Investigational Site | Columbus | Ohio | United States | 43214 |
| 19 | Pfizer Investigational Site | Columbus | Ohio | United States | 43215 |
| 20 | Pfizer Investigational Site | Upper Arlington | Ohio | United States | 43220 |
| 21 | Pfizer Investigational Site | Allentown | Pennsylvania | United States | 18103 |
| 22 | Pfizer Investigational Site | King Of Prussia | Pennsylvania | United States | 19406 |
| 23 | Pfizer Investigational Site | Philadelphia | Pennsylvania | United States | 19107 |
| 24 | Pfizer Investigational Site | Pittsburgh | Pennsylvania | United States | 15213-2582 |
| 25 | Pfizer Investigational Site | Pittsburgh | Pennsylvania | United States | 15232 |
| 26 | Pfizer Investigational Site | Dallas | Texas | United States | 75390 |
| 27 | Pfizer Investigational Site | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
ClinicalTrials.gov Identifier:
NCT00442546
Other Study ID Numbers:
- A0081133
First Posted:
Mar 2, 2007
Last Update Posted:
Jan 22, 2021
Last Verified:
Oct 1, 2018
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Pregabalin (150 Milligrams [mg]) | Pregabalin (300 mg) | Placebo |
|---|---|---|---|
| Arm/Group Description | Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on Post-Operative Day 1 (POD 1). | Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1. | Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1. |
| Period Title: Overall Study | |||
| STARTED | 103 | 100 | 104 |
| Received Treatment | 98 | 96 | 98 |
| COMPLETED | 77 | 63 | 71 |
| NOT COMPLETED | 26 | 37 | 33 |
Baseline Characteristics
| Arm/Group Title | Pregabalin (150 mg) | Pregabalin (300 mg) | Placebo | Total |
|---|---|---|---|---|
| Arm/Group Description | Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1. | Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1. | Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1. | Total of all reporting groups |
| Overall Participants | 98 | 96 | 98 | 292 |
| Age, Customized (participants) [Number] | ||||
| 18 to 44 years |
1
1%
|
2
2.1%
|
4
4.1%
|
7
2.4%
|
| 45 to 64 years |
52
53.1%
|
44
45.8%
|
49
50%
|
145
49.7%
|
| > = 65 years |
45
45.9%
|
50
52.1%
|
45
45.9%
|
140
47.9%
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
60
61.2%
|
61
63.5%
|
54
55.1%
|
175
59.9%
|
| Male |
38
38.8%
|
35
36.5%
|
44
44.9%
|
117
40.1%
|
Outcome Measures
| Title | Subject Reported Worst Pain Score in Daily Diaries Using the Worst Pain Item of the Modified Brief Pain Inventory - Short Form (m-BPI-sf) |
|---|---|
| Description | The mBPI-SF is a self administered questionnaire developed to assess pain severity and pain interference with functional activities during a 24-hour period prior to evaluation. For the Worst Pain item of the m-BPI-sf scale (11 point Likert scale; range: 0 [no pain] to 10 [pain as bad as you can imagine]), subjects were asked to rate their pain by marking an "X" in one of the ten boxes that best described their pain at its worst in the last 24 hours post surgery and at least 12 hours after discontinuation of the peripheral nerve block or neuroaxial block. |
| Time Frame | 48 hours after surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| Modified Intent-to-Treat (MITT) Population=all ITT subjects who took 12 and 2 hours pre-surgery study medications, had no surgical or anesthetic complications during total knee replacement surgery and had at least 1 post surgery primary efficacy measurement. |
| Arm/Group Title | Pregabalin (150 mg) | Pregabalin (300 mg) | Placebo |
|---|---|---|---|
| Arm/Group Description | Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1. | Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1. | Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1. |
| Measure Participants | 78 | 82 | 75 |
| Least Squares Mean (Standard Error) [scores on a scale] |
7.041
(0.267)
|
6.740
(0.264)
|
7.079
(0.279)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9185 |
| Comments | A step-down procedure was used for multiple comparisons adjustment. If the difference between the high dose and placebo groups was statistically significant (p<0.05), then the next step conducted where the low dose group was compared to placebo. | |
| Method | ANOVA | |
| Comments | Least squares means from the analysis of variance (ANOVA) model with main effects of treatment and center and Baseline mean worst pain score. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.038 | |
| Confidence Interval |
() 95% -0.766 to 0.691 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.370 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3619 |
| Comments | A step-down procedure was used for multiple comparisons adjustment. If the difference between the high dose and placebo groups was statistically significant (p<0.05), then the next step conducted where the low dose group was compared to placebo. | |
| Method | ANOVA | |
| Comments | Least squares means from the ANOVA model with main effects of treatment and center and Baseline mean worst pain score. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.339 | |
| Confidence Interval |
() 95% -1.070 to 0.392 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.371 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
| Title | Cumulative Total Amount of Opioids Used During the Entire Hospital Stay |
|---|---|
| Description | Total cumulative dose calculated as mg of oral morphine equivalent and included opioids given by any route (patient controlled analgesia [PCA] pump, parenteral bolus or oral). Results for daily total not including pregabalin (not an opioid). Statistical model included main effect of treatment group and center. 1 subject at 144 h, 300 mg=non-missing data. Due to small sample size (N=1, 300 mg; N=5, other groups) and large opioid consumption for another subject in same center, least squares mean (300 mg, 144 h) is negative. |
| Time Frame | 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours, 168 hours, 192 hours, 216 hours |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT. There were not enough subjects with data at 168, 192, and 216 hours to calculate least squares mean values. |
| Arm/Group Title | Pregabalin (150 mg) | Pregabalin (300 mg) | Placebo |
|---|---|---|---|
| Arm/Group Description | Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1. | Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1. | Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1. |
| Measure Participants | 85 | 86 | 84 |
| 24 hours (n=85, 86, 84) |
151.790
(14.210)
|
152.306
(14.313)
|
167.854
(14.573)
|
| 48 hours (n=82, 81, 83) |
86.402
(12.057)
|
93.846
(12.292)
|
122.830
(12.304)
|
| 72 hours (n=60, 60, 60) |
55.654
(9.175)
|
48.713
(9.420)
|
52.895
(9.851)
|
| 96 hours (n=32, 39, 35) |
31.976
(7.928)
|
24.758
(7.861)
|
35.332
(8.354)
|
| 120 hours (n=12, 6, 13) |
27.520
(13.146)
|
14.235
(17.684)
|
27.559
(13.306)
|
| 144 hours (n=5, 1, 5) |
33.956
(12.019)
|
-64.544
(28.633)
|
73.956
(16.720)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | 24 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4091 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -16.065 | |
| Confidence Interval |
() 95% -54.332 to 22.203 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 19.426 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | 24 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4234 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -15.548 | |
| Confidence Interval |
() 95% -53.740 to 22.645 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 19.388 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | 48 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0284 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -36.428 | |
| Confidence Interval |
() 95% -68.972 to -3.884 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 16.517 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | 48 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0816 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -28.985 | |
| Confidence Interval |
() 95% -61.632 to 3.663 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 16.570 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | 72 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8147 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 2.759 | |
| Confidence Interval |
() 95% -20.446 to 25.964 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 11.752 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | 72 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7187 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -4.182 | |
| Confidence Interval |
() 95% -27.064 to 18.700 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 11.589 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | 96 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7416 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -3.356 | |
| Confidence Interval |
() 95% -23.516 to 16.804 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 10.148 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | 96 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2577 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -10.574 | |
| Confidence Interval |
() 95% -29.017 to 7.869 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 9.283 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | 120 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9982 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.039 | |
| Confidence Interval |
() 95% -36.431 to 36.352 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 17.387 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | 120 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5552 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -13.325 | |
| Confidence Interval |
() 95% -59.756 to 33.107 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 22.184 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | 144 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2032 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -40.000 | |
| Confidence Interval |
() 95% -118.463 to 38.463 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 24.655 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | 144 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0348 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -138.500 | |
| Confidence Interval |
() 95% -258.354 to -18.646 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 37.661 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
| Title | Opioids Used Post Discharge |
|---|---|
| Description | The amount of opioid use was calculated as mg of oral morphine equivalent and included opioids administered by any route (PCA pump, parenteral bolus, or oral). Weeks 2, 4, and 6 total daily doses were calculated by adding the cumulative doses during the 2 week period prior to the visit and dividing them by the number of days in the period. This outcome measure does not include pregabalin as it is not an opioid. |
| Time Frame | Week 2, Week 4, Week 6/Early Termination (ET) |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT |
| Arm/Group Title | Pregabalin (150 mg) | Pregabalin (300 mg) | Placebo |
|---|---|---|---|
| Arm/Group Description | Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1. | Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1. | Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1. |
| Measure Participants | 41 | 40 | 36 |
| Week 2 (n=41, 40, 36) |
30.255
(3.515)
|
27.692
(3.534)
|
26.119
(3.789)
|
| Week 4 (n=33, 33, 30) |
37.130
(4.975)
|
37.507
(4.911)
|
34.271
(5.274)
|
| Week 6/ET (n=24, 28, 22) |
38.686
(6.261)
|
35.945
(5.888)
|
35.036
(6.401)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Week 2 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3602 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 4.136 | |
| Confidence Interval |
() 95% -4.790 to 13.062 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 4.499 |
|
| Estimation Comments | Mean Difference (Final Values) = Least Squares Mean Difference | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Week 2 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7352 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 1.573 | |
| Confidence Interval |
() 95% -7.626 to 10.771 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 4.637 |
|
| Estimation Comments | Mean Difference (Final Values) = Least Squares Mean Difference | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Week 4 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6435 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 2.860 | |
| Confidence Interval |
() 95% -9.392 to 15.111 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 6.156 |
|
| Estimation Comments | Mean Difference (Final Values) = Least Squares Mean Difference | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Week 4 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6123 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 3.237 | |
| Confidence Interval |
() 95% -9.422 to 15.895 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 6.361 |
|
| Estimation Comments | Mean Difference (Final Values) = Least Squares Mean Difference | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Week 6/ET | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6356 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 3.650 | |
| Confidence Interval |
() 95% -11.683 to 18.984 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 7.663 |
|
| Estimation Comments | Mean Difference (Final Values) = Least Squares Mean Difference | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Week 6/ET | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9070 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.909 | |
| Confidence Interval |
() 95% -14.593 to 16.411 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 7.747 |
|
| Estimation Comments | Mean Difference (Final Values) = Least Squares Mean Difference | |
| Title | Analgesics Used During the Hospital Stay (Acetylsalicylic Acid, Ketorolac, and Paracetamol) |
|---|---|
| Description | Total dose for in-hospital visits was the total dose for the day. |
| Time Frame | 24 hours, 48 hours, 72 hours |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT. There were not enough subjects with data to calculate least squares mean values at 24 and 48 hours for Acetylalicyclic Acid and 72 hours for Ketorolac. |
| Arm/Group Title | Pregabalin (150 mg) | Pregabalin (300 mg) | Placebo |
|---|---|---|---|
| Arm/Group Description | Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1. | Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1. | Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1. |
| Measure Participants | 22 | 25 | 17 |
| Acetylsalicylic Acid, 72 hours (n=3, 1, 1) |
235.175
(61.531)
|
1442.025
(117.823)
|
1425.825
(117.823)
|
| Ketorolac, 24 hours, (n=1, 4, 3) |
32.961
(57.230)
|
53.432
(28.615)
|
27.189
(31.346)
|
| Ketorolac, 48 hours, (n=2, 8, 4) |
20.553
(7.971)
|
21.863
(3.862)
|
23.473
(5.520)
|
| Paracetamol, 24 hours (n=14, 20, 16) |
1311.246
(359.886)
|
1363.086
(283.808)
|
1380.481
(309.224)
|
| Paracetamol, 48 hours (n=22, 25, 17) |
1357.030
(371.095)
|
1368.880
(339.509)
|
1263.337
(443.695)
|
| Paracetamol, 72 hours (n=12, 13, 16) |
446.050
(445.588)
|
877.916
(403.657)
|
1128.355
(347.457)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Acetylsalicylic Acid, 72 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0656 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -1190.650 | |
| Confidence Interval |
() 95% -2754.304 to 373.004 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 123.062 |
|
| Estimation Comments | Mean Difference (Final Values) = Least Squares Mean Difference | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Acetylsalicylic Acid, 72 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9277 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 16.200 | |
| Confidence Interval |
() 95% -1789.352 to 1821.752 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 142.100 |
|
| Estimation Comments | Mean Difference (Final Values) = Least Squares Mean Difference | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Ketorolac, 24 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9350 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 5.771 | |
| Confidence Interval |
() 95% -263.972 to 275.515 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 62.692 |
|
| Estimation Comments | Mean Difference (Final Values) = Least Squares Mean Difference | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Ketorolac, 24 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6139 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 26.243 | |
| Confidence Interval |
() 95% -164.494 to 216.980 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 44.330 |
|
| Estimation Comments | Mean Difference (Final Values) = Least Squares Mean Difference | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Ketorolac, 48 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7760 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -2.920 | |
| Confidence Interval |
() 95% -25.451 to 19.611 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 9.960 |
|
| Estimation Comments | Mean Difference (Final Values) = Least Squares Mean Difference | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Ketorolac, 48 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8190 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -1.610 | |
| Confidence Interval |
() 95% -17.066 to 13.846 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 6.833 |
|
| Estimation Comments | Mean Difference (Final Values) = Least Squares Mean Difference | |
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Paracetamol, 24 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8603 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -69.235 | |
| Confidence Interval |
() 95% -861.171 to 722.700 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 390.483 |
|
| Estimation Comments | Mean Difference (Final Values) = Least Squares Mean Difference | |
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Paracetamol, 24 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9642 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -17.395 | |
| Confidence Interval |
() 95% -796.945 to 762.155 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 384.376 |
|
| Estimation Comments | Mean Difference (Final Values) = Least Squares Mean Difference | |
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Paracetamol, 48 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8476 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 93.693 | |
| Confidence Interval |
() 95% -880.865 to 1068.251 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 484.957 |
|
| Estimation Comments | Mean Difference (Final Values) = Least Squares Mean Difference | |
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Paracetamol, 48 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8185 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 105.543 | |
| Confidence Interval |
() 95% -813.584 to 1024.670 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 457.374 |
|
| Estimation Comments | Mean Difference (Final Values) = Least Squares Mean Difference | |
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Paracetamol, 72 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1792 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -682.304 | |
| Confidence Interval |
() 95% -1696.759 to 332.150 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 495.241 |
|
| Estimation Comments | Mean Difference (Final Values) = Least Squares Mean Difference | |
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Paracetamol, 72 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6216 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -250.439 | |
| Confidence Interval |
() 95% -1278.347 to 777.469 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 501.808 |
|
| Estimation Comments | Mean Difference (Final Values) = Least Squares Mean Difference | |
| Title | Analgesics Used Post Discharge (Acetylsalicylic Acid [Week 2] and Paracetamol [Weeks 2, 4, and 6] |
|---|---|
| Description | Weeks 2, 4, and 6 total daily doses were calculated by adding the cumulative doses during the 2 week period prior to the visit and dividing them by the number of days in the period. |
| Time Frame | Week 2, Week 4, Week 6/ET |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT. |
| Arm/Group Title | Pregabalin (150 mg) | Pregabalin (300 mg) | Placebo |
|---|---|---|---|
| Arm/Group Description | Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1. | Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1. | Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1. |
| Measure Participants | 7 | 14 | 7 |
| Acetylsalicylic Acid, Week 2 (n=6, 1, 2) |
498.613
(130.446)
|
797.463
(361.189)
|
992.613
(291.687)
|
| Paracetamol, Week 2 (n=7, 13, 7) |
603.496
(232.179)
|
665.574
(164.777)
|
630.787
(247.693)
|
| Paracetamol, Week 4 (n=5, 12, 6) |
792.434
(412.260)
|
779.226
(260.034)
|
593.498
(375.124)
|
| Paracetamol, Week 6/ET (n=6, 14, 5) |
1128.952
(290.993)
|
1098.840
(223.948)
|
1385.873
(334.859)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Acetylsalicylic Acid, Week 2. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1996 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -494.000 | |
| Confidence Interval |
() 95% -1452.720 to 464.720 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 301.253 |
|
| Estimation Comments | Mean Difference (Final Values) = Least Squares Mean Difference | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Acetylsalicylic Acid, Week 2. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6335 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -195.150 | |
| Confidence Interval |
() 95% -1369.338 to 979.038 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 368.958 |
|
| Estimation Comments | Mean Difference (Final Values) = Least Squares Mean Difference | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Paracetamol, Week 2 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9290 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -27.291 | |
| Confidence Interval |
() 95% -657.992 to 603.410 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 302.355 |
|
| Estimation Comments | Mean Difference (Final Values) = Least Squares Mean Difference | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Paracetamol, Week 2 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8937 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 34.787 | |
| Confidence Interval |
() 95% -501.241 to 570.815 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 256.969 |
|
| Estimation Comments | Mean Difference (Final Values) = Least Squares Mean Difference | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Paracetamol, Week 4 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6912 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 198.937 | |
| Confidence Interval |
() 95% -847.930 to 1245.804 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 491.153 |
|
| Estimation Comments | Mean Difference (Final Values) = Least Squares Mean Difference | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Paracetamol, Week 4 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6024 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 185.728 | |
| Confidence Interval |
() 95% -558.248 to 929.704 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 349.047 |
|
| Estimation Comments | Mean Difference (Final Values) = Least Squares Mean Difference | |
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Paracetamol, Week 6/ET | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5372 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -256.921 | |
| Confidence Interval |
() 95% -1120.551 to 606.709 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 407.391 |
|
| Estimation Comments | Mean Difference (Final Values) = Least Squares Mean Difference | |
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Paracetamol, Week 6/ET | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3948 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -287.032 | |
| Confidence Interval |
() 95% -982.843 to 408.778 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 328.227 |
|
| Estimation Comments | Mean Difference (Final Values) = Least Squares Mean Difference | |
| Title | Analgesics Used Post Discharge (Ibuprofen) for the Pregabalin 150 mg and Placebo Treatment Groups |
|---|---|
| Description | Weeks 2, 4, and 6 total daily doses were calculated by adding the cumulative doses during the 2 week period prior to the visit and dividing them by the number of days in the period. |
| Time Frame | Week 2, Week 4, Week 6/ET |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT. There were not enough subjects with data at Week 2 and Week 4 for Ibuprofen to calculate least squares mean values. |
| Arm/Group Title | Pregabalin (150 mg) | Placebo |
|---|---|---|
| Arm/Group Description | Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1. | Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1. |
| Measure Participants | 3 | 1 |
| Least Squares Mean (Standard Error) [mg] |
862.350
(584.827)
|
983.850
(1119.858)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Pregabalin (300 mg) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9341 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -121.500 | |
| Confidence Interval |
(2-Sided) 95% -14983.36 to 14740.362 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1169.654 |
|
| Estimation Comments | Mean Difference (Final Values) = Least Squares Mean Difference | |
| Title | Analgesics Used Post Discharge (Ibuprofen) for the Pregabalin 300 mg Treatment Group |
|---|---|
| Description | Weeks 2, 4, and 6 total daily doses were calculated by adding the cumulative doses during the 2 week period prior to the visit and dividing them by the number of days in the period. |
| Time Frame | Week 2, Week 4, Week 6/ET |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT. There were not enough subjects with data at Week 2 for Ibuprofen to calculate least squares mean values. |
| Arm/Group Title | Pregabalin (300 mg) |
|---|---|
| Arm/Group Description | Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1. |
| Measure Participants | 0 |
| Title | Analgesics Used Post Discharge (Acetylsalicylic Acid) for the Pregabalin 150 mg and Placebo Treatment Groups at Week 4 |
|---|---|
| Description | Week 4 total daily dose was calculated by adding the cumulative doses during the 2 week period prior to the visit and dividing them by the number of days in the period. |
| Time Frame | Week 4 |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT |
| Arm/Group Title | Pregabalin (150 mg) | Placebo |
|---|---|---|
| Arm/Group Description | Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1. | Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1. |
| Measure Participants | 5 | 1 |
| Median (Full Range) [mg] |
650.000
(0.000)
|
22.100
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Pregabalin (300 mg) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 302.900 | |
| Confidence Interval |
(2-Sided) 95% 302.900 to 302.900 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.000 |
|
| Estimation Comments | Mean Difference (Final Values) = Least Squares Mean Difference | |
| Title | Analgesics Used Post Discharge (Acetylsalicylic Acid) for the Pregabalin 300 mg Treatment Group at Week 4 |
|---|---|
| Description | Week 4 total daily dose was calculated by adding the cumulative doses during the 2 week period prior to the visit and dividing them by the number of days in the period. |
| Time Frame | Week 4 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Pregabalin (300 mg) |
|---|---|
| Arm/Group Description | Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1. |
| Measure Participants | 0 |
| Title | Analgesics Used Post Discharge (Acetylsalicylic Acid) for the Pregabalin 150 mg and Placebo Treatment Groups at Week 6/ET |
|---|---|
| Description | Week 6 total daily dose was calculated by adding the cumulative doses during the 2 week period prior to the visit and dividing them by the number of days in the period. |
| Time Frame | Week 6/ET |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT |
| Arm/Group Title | Pregabalin (150 mg) |
|---|---|
| Arm/Group Description | Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1. |
| Measure Participants | 5 |
| Least Squares Mean (Standard Error) [mg] |
513.163
(200.647)
|
| Title | Analgesics Used Post Discharge (Acetylsalicylic Acid) for the Pregabalin 300 mg and Placebo Treatment Groups at Week 6/ET |
|---|---|
| Description | Week 6 total daily dose was calculated by adding the cumulative doses during the 2 week period prior to the visit and dividing them by the number of days in the period. |
| Time Frame | Week 6/ET |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT |
| Arm/Group Title | Pregabalin (300 mg) | Placebo |
|---|---|---|
| Arm/Group Description | Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1. | Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1. |
| Measure Participants | 0 | 0 |
| Title | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the Opioid-Related Symptom Distress Scale (OR-SDS) - Frequency Composite Score |
|---|---|
| Description | The OR-SDS was used to assess subject-reported levels of frequency concerning 10 symptoms known to be associated with opioid medication usage: fatigue, drowsiness, inability to concentrate, nausea, dizziness, constipation, itching, difficulty with urination, confusion, and retching/vomiting. Symptom frequency was rated as: 1=rarely, 2=occasionally, 3=frequently, or 4=almost constantly. The average score for each symptom was calculated by taking the mean of patient-reported score. Total possible frequency score: 0 (less frequent) to 4 (more frequent). |
| Time Frame | 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, Discharge, Week 2, Week 4, Week 6/ET |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT. |
| Arm/Group Title | Pregabalin (150 mg) | Pregabalin (300 mg) | Placebo |
|---|---|---|---|
| Arm/Group Description | Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1. | Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1. | Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1. |
| Measure Participants | 87 | 86 | 81 |
| 24 hours (n=72, 69, 69) |
0.767
(0.069)
|
0.808
(0.072)
|
0.888
(0.074)
|
| 48 hours (n=83, 86, 76) |
0.782
(0.061)
|
0.779
(0.060)
|
0.908
(0.063)
|
| 72 hours (n=81, 77, 73) |
0.669
(0.064)
|
0.688
(0.066)
|
0.726
(0.069)
|
| 96 hours (n=49, 53, 54) |
0.623
(0.087)
|
0.656
(0.083)
|
0.676
(0.082)
|
| 120 hours (n=19, 17, 23) |
0.427
(0.086)
|
0.405
(0.087)
|
0.446
(0.087)
|
| Discharge (n=86, 85, 81) |
0.567
(0.056)
|
0.619
(0.056)
|
0.664
(0.058)
|
| Week 2 (n=87, 78, 79) |
0.535
(0.056)
|
0.525
(0.058)
|
0.513
(0.059)
|
| Week 4 (n=77, 69, 67) |
0.402
(0.048)
|
0.415
(0.050)
|
0.391
(0.053)
|
| Week 6/ET (n=78, 66, 71) |
0.249
(0.043)
|
0.386
(0.047)
|
0.239
(0.047)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | 24 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1661 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.121 | |
| Confidence Interval |
() 95% -0.293 to 0.051 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.087 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | 24 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3604 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.081 | |
| Confidence Interval |
() 95% -0.254 to 0.093 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.088 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | 48 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1299 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.126 | |
| Confidence Interval |
() 95% -0.290 to 0.037 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.083 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | 48 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1167 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.129 | |
| Confidence Interval |
() 95% -0.290 to 0.032 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.082 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | 72 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5271 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.057 | |
| Confidence Interval |
() 95% -0.234 to 0.120 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.090 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | 72 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6731 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.038 | |
| Confidence Interval |
() 95% -0.215 to 0.139 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.090 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | 96 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5936 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.053 | |
| Confidence Interval |
() 95% -0.247 to 0.142 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.098 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | 96 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8368 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.019 | |
| Confidence Interval |
() 95% -0.206 to 0.167 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.094 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | 120 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8659 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.019 | |
| Confidence Interval |
() 95% -0.242 to 0.204 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.111 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | 120 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7151 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.041 | |
| Confidence Interval |
() 95% -0.266 to 0.184 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.112 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Discharge | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2121 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.097 | |
| Confidence Interval |
() 95% -0.249 to 0.056 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.077 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Discharge | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5607 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.045 | |
| Confidence Interval |
() 95% -0.197 to 0.107 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.077 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 13
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Week 2 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7797 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.022 | |
| Confidence Interval |
() 95% -0.130 to 0.173 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.077 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 14
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Week 2 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8761 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.012 | |
| Confidence Interval |
() 95% -0.143 to 0.167 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.079 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 15
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Week 4 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8619 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.012 | |
| Confidence Interval |
() 95% -0.121 to 0.144 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.067 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 16
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Week 4 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7256 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.024 | |
| Confidence Interval |
() 95% -0.111 to 0.159 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.068 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 17
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Week 6/ET | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8659 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.010 | |
| Confidence Interval |
() 95% -0.110 to 0.131 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.061 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 18
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Week 6/ET | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0203 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.146 | |
| Confidence Interval |
() 95% 0.023 to 0.270 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.063 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
| Title | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Severity Composite Score |
|---|---|
| Description | The OR-SDS was used to assess subject-reported levels of severity concerning 10 symptoms known to be associated with opioid medication usage: fatigue, drowsiness, inability to concentrate, nausea, dizziness, constipation, itching, difficulty with urination, confusion, and retching/vomiting. Symptom severity was rated as: 1=slight, 2=moderate, 3=severe, or 4=very severe. The average score for each symptom was calculated by taking the mean of patient-reported score. Total possible severity score: 0 (less severe) to 4 (more severe). |
| Time Frame | 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, Discharge, Week 2, Week 4, Week 6/ET |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT |
| Arm/Group Title | Pregabalin (150 mg) | Pregabalin (300 mg) | Placebo |
|---|---|---|---|
| Arm/Group Description | Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1. | Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1. | Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1. |
| Measure Participants | 87 | 86 | 82 |
| 24 hours (n=72, 69, 69) |
0.579
(0.059)
|
0.590
(0.061)
|
0.621
(0.062)
|
| 48 hours (n=83, 86, 77) |
0.642
(0.051)
|
0.624
(0.050)
|
0.695
(0.053)
|
| 72 hours (n=81, 77, 73) |
0.539
(0.054)
|
0.534
(0.055)
|
0.562
(0.057)
|
| 96 hours (n=49, 53, 54) |
0.509
(0.070)
|
0.502
(0.067)
|
0.535
(0.066)
|
| 120 hours (n=19, 17, 23) |
0.366
(0.066)
|
0.334
(0.067)
|
0.391
(0.066)
|
| Discharge (n=86, 85, 82) |
0.451
(0.048)
|
0.495
(0.048)
|
0.488
(0.049)
|
| Week 2 (n=87, 78, 79) |
0.390
(0.043)
|
0.375
(0.045)
|
0.364
(0.045)
|
| Week 4 (n=77, 69, 67) |
0.269
(0.034)
|
0.308
(0.036)
|
0.247
(0.037)
|
| Week 6/ET (n=78, 66, 71) |
0.182
(0.034)
|
0.282
(0.037)
|
0.175
(0.037)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | 24 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5791 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.041 | |
| Confidence Interval |
() 95% -0.187 to 0.105 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.074 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | 24 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6829 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.031 | |
| Confidence Interval |
() 95% -0.178 to 0.117 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.075 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | 48 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4516 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.053 | |
| Confidence Interval |
() 95% -0.190 to 0.085 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.070 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | 48 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3014 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.071 | |
| Confidence Interval |
() 95% -0.207 to 0.064 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.069 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | 72 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7628 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.023 | |
| Confidence Interval |
() 95% -0.171 to 0.125 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.075 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | 72 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7110 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.028 | |
| Confidence Interval |
() 95% -0.176 to 0.120 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.075 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | 96 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7382 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.026 | |
| Confidence Interval |
() 95% -0.183 to 0.130 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.079 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | 96 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6586 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.034 | |
| Confidence Interval |
() 95% -0.183 to 0.116 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.076 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | 120 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7691 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.025 | |
| Confidence Interval |
() 95% -0.195 to 0.145 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.084 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | 120 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5070 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.057 | |
| Confidence Interval |
() 95% -0.229 to 0.115 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.085 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Discharge | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5802 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.036 | |
| Confidence Interval |
() 95% -0.166 to 0.093 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.066 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Discharge | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9190 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.007 | |
| Confidence Interval |
() 95% -0.122 to 0.136 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.065 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 13
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Week 2 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6559 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.026 | |
| Confidence Interval |
() 95% -0.090 to 0.143 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.059 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 14
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Week 2 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8552 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.011 | |
| Confidence Interval |
() 95% -0.108 to 0.130 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.060 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 15
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Week 4 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6364 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.023 | |
| Confidence Interval |
() 95% -0.072 to 0.117 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.048 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 16
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Week 4 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2127 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.061 | |
| Confidence Interval |
() 95% -0.035 to 0.157 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.049 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 17
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Week 6/ET | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8746 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.007 | |
| Confidence Interval |
() 95% -0.086 to 0.101 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.047 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 18
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Week 6/ET | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0286 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.107 | |
| Confidence Interval |
() 95% 0.011 to 0.202 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.048 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
| Title | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Degree of Bother Composite Score |
|---|---|
| Description | The OR-SDS was used to assess subject-reported level of degree of bother concerning 10 symptoms known to be associated with opioid medication usage: fatigue, drowsiness, inability to concentrate, nausea, dizziness, constipation, itching, difficulty with urination, confusion, and retching/vomiting. Symptom degree of bother was rated as: 1=not at all, 2=a little bit, 3=somewhat, 4=quite a bit, or 5=very much. Average score for each symptom was calculated by taking the mean of patient-reported score. Total possible degree of bother score: 0 (less degree of bother) to 5 (greater degree of bother). |
| Time Frame | 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, Discharge, Week 2, Week 4, Week 6/ET |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT |
| Arm/Group Title | Pregabalin (150 mg) | Pregabalin (300 mg) | Placebo |
|---|---|---|---|
| Arm/Group Description | Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1. | Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1. | Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1. |
| Measure Participants | 87 | 86 | 82 |
| 24 hours (n=72, 69, 69) |
0.671
(0.081)
|
0.788
(0.084)
|
0.836
(0.086)
|
| 48 hours (n=83, 86, 77) |
0.810
(0.067)
|
0.769
(0.066)
|
0.918
(0.070)
|
| 72 hours (n=81, 77, 73) |
0.686
(0.077)
|
0.694
(0.080)
|
0.822
(0.083)
|
| 96 hours (n=49, 53, 54) |
0.572
(0.096)
|
0.623
(0.092)
|
0.703
(0.090)
|
| 120 hours (n=19, 17, 23) |
0.565
(0.111)
|
0.439
(0.113)
|
0.574
(0.113)
|
| Discharge (n=86, 85, 82) |
0.575
(0.067)
|
0.616
(0.067)
|
0.697
(0.069)
|
| Week 2 (n=87, 78, 79) |
0.527
(0.063)
|
0.506
(0.066)
|
0.533
(0.067)
|
| Week 4 (n=77, 69, 67) |
0.395
(0.053)
|
0.433
(0.055)
|
0.354
(0.058)
|
| Week 6/ET (n=78, 66, 71) |
0.260
(0.049)
|
0.401
(0.053)
|
0.274
(0.053)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | 24 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1078 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.165 | |
| Confidence Interval |
() 95% -0.367 to 0.036 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.102 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | 24 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6406 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.048 | |
| Confidence Interval |
() 95% -0.252 to 0.155 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.103 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | 48 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2404 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.108 | |
| Confidence Interval |
() 95% -0.289 to 0.073 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.092 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | 48 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1005 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.149 | |
| Confidence Interval |
() 95% -0.327 to 0.029 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.090 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | 72 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2109 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.136 | |
| Confidence Interval |
() 95% -0.349 to 0.078 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.108 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | 72 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2399 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.128 | |
| Confidence Interval |
() 95% -0.342 to 0.086 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.108 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | 96 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2272 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.131 | |
| Confidence Interval |
() 95% -0.346 to 0.083 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.108 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | 96 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4417 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.080 | |
| Confidence Interval |
() 95% -0.285 to 0.125 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.104 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | 120 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9502 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.009 | |
| Confidence Interval |
() 95% -0.299 to 0.281 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.144 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | 120 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3550 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.135 | |
| Confidence Interval |
() 95% -0.426 to 0.156 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.144 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Discharge | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1888 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.122 | |
| Confidence Interval |
() 95% -0.304 to 0.060 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.092 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Discharge | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3774 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.081 | |
| Confidence Interval |
() 95% -0.262 to 0.100 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.092 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 13
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Week 2 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9452 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.006 | |
| Confidence Interval |
() 95% -0.178 to 0.166 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.087 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 14
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Week 2 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7663 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.026 | |
| Confidence Interval |
() 95% -0.201 to 0.148 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.089 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 15
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Week 4 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5777 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.041 | |
| Confidence Interval |
() 95% -0.104 to 0.186 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.074 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 16
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Week 4 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2916 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.079 | |
| Confidence Interval |
() 95% -0.069 to 0.227 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.075 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 17
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Week 6/ET | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8389 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.014 | |
| Confidence Interval |
() 95% -0.150 to 0.122 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.069 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 18
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Week 6/ET | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0734 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.127 | |
| Confidence Interval |
() 95% -0.012 to 0.266 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.070 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
| Title | The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Overall Composite Score |
|---|---|
| Description | The OR-SDS assessed subject-reported levels of frequency, severity and degree of bother for 10 symptoms known to be associated with opioid medication usage: fatigue, drowsiness, inability to concentrate, nausea, dizziness, constipation, itching, difficulty with urination, confusion, retching and vomiting. The overall composite score was the average across frequency, severity, and degree of bother scores. Total possible score: 0 (better) to 4.34 (worse). |
| Time Frame | 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, Discharge, Week 2, Week 4, Week 6/ET |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT |
| Arm/Group Title | Pregabalin (150 mg) | Pregabalin (300 mg) | Placebo |
|---|---|---|---|
| Arm/Group Description | Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1. | Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1. | Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1. |
| Measure Participants | 87 | 86 | 82 |
| 24 hours (n=72, 69, 69) |
0.669
(0.067)
|
0.727
(0.069)
|
0.778
(0.071)
|
| 48 hours (n=83, 86, 77) |
0.743
(0.056)
|
0.722
(0.055)
|
0.838
(0.059)
|
| 72 hours (n=81, 77, 73) |
0.630
(0.063)
|
0.637
(0.065)
|
0.703
(0.067)
|
| 96 hours (n=49, 53, 54) |
0.567
(0.082)
|
0.593
(0.079)
|
0.637
(0.077)
|
| 120 hours (n=19, 17, 23) |
0.453
(0.084)
|
0.393
(0.086)
|
0.471
(0.085)
|
| Discharge (n=86, 85, 82) |
0.530
(0.055)
|
0.575
(0.055)
|
0.615
(0.056)
|
| Week 2 (n=87, 78, 79) |
0.482
(0.052)
|
0.467
(0.055)
|
0.469
(0.056)
|
| Week 4 (n=77, 69, 67) |
0.354
(0.044)
|
0.384
(0.046)
|
0.329
(0.048)
|
| Week 6/ET (n=78, 66, 71) |
0.230
(0.041)
|
0.355
(0.045)
|
0.229
(0.045)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | 24 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1949 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.110 | |
| Confidence Interval |
() 95% -0.276 to 0.057 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.084 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | 24 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5431 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.052 | |
| Confidence Interval |
() 95% -0.220 to 0.116 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.085 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | 48 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2164 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.095 | |
| Confidence Interval |
() 95% -0.247 to 0.056 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.077 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | 48 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1251 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.117 | |
| Confidence Interval |
() 95% -0.266 to 0.033 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.076 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | 72 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4079 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.073 | |
| Confidence Interval |
() 95% -0.247 to 0.101 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.088 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | 72 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4562 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.066 | |
| Confidence Interval |
() 95% -0.240 to 0.108 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.088 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | 96 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4526 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.070 | |
| Confidence Interval |
() 95% -0.254 to 0.114 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.093 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | 96 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6186 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.045 | |
| Confidence Interval |
() 95% -0.221 to 0.132 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.089 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | 120 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8712 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.018 | |
| Confidence Interval |
() 95% -0.237 to 0.202 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.109 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | 120 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4784 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.078 | |
| Confidence Interval |
() 95% -0.300 to 0.143 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.110 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Discharge | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2635 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.084 | |
| Confidence Interval |
() 95% -0.232 to 0.064 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.075 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Discharge | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6009 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.039 | |
| Confidence Interval |
() 95% -0.187 to 0.108 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.075 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 13
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Week 2 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8559 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.013 | |
| Confidence Interval |
() 95% -0.130 to 0.156 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.073 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 14
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Week 2 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9841 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.001 | |
| Confidence Interval |
() 95% -0.147 to 0.144 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.074 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 15
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Week 4 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6771 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.025 | |
| Confidence Interval |
() 95% -0.095 to 0.146 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.061 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 16
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Week 4 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3717 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.056 | |
| Confidence Interval |
() 95% -0.067 to 0.178 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.062 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 17
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Week 6/ET | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9863 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.001 | |
| Confidence Interval |
() 95% -0.114 to 0.116 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.058 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 18
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Week 6/ET | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0355 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.126 | |
| Confidence Interval |
() 95% 0.009 to 0.243 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.059 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
| Title | Total Clinically Meaningful Event (CME) Score |
|---|---|
| Description | CMEs were defined using OR-SDS (assesses subject-reported levels of severity concerning 10 symptoms associated with opioid medication usage: fatigue, drowsiness, inability to concentrate, nausea, dizziness, constipation, itching, difficulty with urination, confusion and retching/vomiting). CME = any symptom rated as severe or very severe, with the exception of confusion. Confusion was defined as a CME if the severity score was at least moderate. Total score = the sum of CMEs across symptoms. Each CME = 1 point. Total CME score ranges from 0 to 9. |
| Time Frame | 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, Discharge, Week 2, Week 4, and Week 6/ET |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT. |
| Arm/Group Title | Pregabalin (150 mg) | Pregabalin (300 mg) | Placebo |
|---|---|---|---|
| Arm/Group Description | Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1. | Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1. | Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1. |
| Measure Participants | 87 | 86 | 82 |
| 24 hours (n=72, 69, 69) |
0.822
(0.161)
|
0.817
(0.166)
|
0.772
(0.171)
|
| 48 hours (n=83, 86, 87) |
0.814
(0.141)
|
0.834
(0.138)
|
0.789
(0.146)
|
| 72 hours (n=81, 77, 73) |
0.647
(0.134)
|
0.570
(0.138)
|
0.613
(0.144)
|
| 96 hours (n=49, 53, 54) |
0.440
(0.173)
|
0.489
(0.164)
|
0.284
(0.162)
|
| 120 hours (n=19, 17, 23) |
0.178
(0.089)
|
0.350
(0.091)
|
0.246
(0.090)
|
| Discharge (n=86, 85, 82) |
0.429
(0.113)
|
0.502
(0.114)
|
0.352
(0.117)
|
| Week 2 (n=87, 78, 79) |
0.328
(0.093)
|
0.311
(0.097)
|
0.171
(0.099)
|
| Week 4 (n=77, 69, 67) |
0.116
(0.059)
|
0.236
(0.062)
|
0.032
(0.064)
|
| Week 6/ET (n=78, 66, 71) |
0.059
(0.062)
|
0.260
(0.068)
|
0.051
(0.067)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | 24 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8071 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.049 | |
| Confidence Interval |
() 95% -0.350 to 0.449 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.202 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | 24 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8282 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.044 | |
| Confidence Interval |
() 95% -0.359 to 0.447 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.204 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | 48 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8972 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.025 | |
| Confidence Interval |
() 95% -0.353 to 0.403 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.192 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | 48 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8159 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.044 | |
| Confidence Interval |
() 95% -0.329 to 0.418 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.190 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | 72 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8577 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.034 | |
| Confidence Interval |
() 95% -0.337 to 0.405 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.188 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | 72 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8158 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.044 | |
| Confidence Interval |
() 95% -0.415 to 0.327 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.188 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | 96 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4243 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.156 | |
| Confidence Interval |
() 95% -0.229 to 0.541 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.195 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | 96 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2742 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.205 | |
| Confidence Interval |
() 95% -0.164 to 0.574 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.187 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | 120 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5569 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.069 | |
| Confidence Interval |
() 95% -0.302 to 0.165 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.116 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | 120 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3762 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.103 | |
| Confidence Interval |
() 95% -0.130 to 0.336 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.116 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Discharge | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6203 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.077 | |
| Confidence Interval |
() 95% -0.229 to 0.383 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.155 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Discharge | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3343 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.150 | |
| Confidence Interval |
() 95% -0.155 to 0.455 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.155 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 13
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Week 2 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2213 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.157 | |
| Confidence Interval |
() 95% -0.096 to 0.410 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.128 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 14
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Week 2 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2863 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.140 | |
| Confidence Interval |
() 95% -0.118 to 0.399 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.131 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 15
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Week 4 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3050 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.084 | |
| Confidence Interval |
() 95% -0.077 to 0.245 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.082 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 16
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Week 4 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0155 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.204 | |
| Confidence Interval |
() 95% 0.039 to 0.368 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.083 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 17
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Week 6/ET | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9243 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.008 | |
| Confidence Interval |
() 95% -0.164 to 0.181 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.087 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 18
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Week 6/ET | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0201 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.210 | |
| Confidence Interval |
() 95% 0.033 to 0.386 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.089 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
| Title | Pain Interference Index Score as Measured by the m-BPI-sf |
|---|---|
| Description | m-BPI-sf questionnaire (7-items) assessed pain interference with functional activities during the past 24 hours. Pain interference index = average of pain interference question (Q) 5A to 5G. Questions were asked as follows: how, during the past 24 hours, has pain interfered with general activity (Q5A), mood (Q5B), walking ability (Q5C), normal work (outside home and housework) (Q5D), relations with other people (Q5E), sleep (Q5F), enjoyment of life (Q5G). Scale: 0=does not interfere to 10=completely interferes. |
| Time Frame | Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6 |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT |
| Arm/Group Title | Pregabalin (150 mg) | Pregabalin (300 mg) | Placebo |
|---|---|---|---|
| Arm/Group Description | Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1. | Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1. | Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1. |
| Measure Participants | 86 | 80 | 80 |
| Discharge (n=83, 80, 74) |
3.427
(0.230)
|
3.488
(0.230)
|
3.887
(0.246)
|
| Week 2 (n=86, 78, 80) |
2.969
(0.236)
|
2.814
(0.245)
|
3.037
(0.251)
|
| Week 4 (n=77, 69, 67) |
2.162
(0.202)
|
1.996
(0.208)
|
2.094
(0.224)
|
| Week 6/ET (n=78, 67, 71) |
1.597
(0.199)
|
1.637
(0.214)
|
1.662
(0.215)
|
| Month 3 (n=30, 32, 35) |
1.139
(0.367)
|
1.335
(0.375)
|
1.629
(0.366)
|
| Month 6 (n=31, 25, 27) |
1.513
(0.264)
|
1.300
(0.241)
|
0.852
(0.253)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Discharge | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1537 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.460 | |
| Confidence Interval |
() 95% -1.093 to 0.173 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.321 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Discharge | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2208 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.398 | |
| Confidence Interval |
() 95% -1.038 to 0.241 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.324 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Week 2 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8355 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.068 | |
| Confidence Interval |
() 95% -0.707 to 0.572 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.325 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Week 2 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5024 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.222 | |
| Confidence Interval |
() 95% -0.875 to 0.430 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.331 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Week 4 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8116 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.067 | |
| Confidence Interval |
() 95% -0.489 to 0.624 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.282 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Week 4 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7325 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.099 | |
| Confidence Interval |
() 95% -0.667 to 0.469 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.288 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Week 6/ET | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8133 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.066 | |
| Confidence Interval |
() 95% -0.614 to 0.482 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.278 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Week 6/ET | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9307 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.025 | |
| Confidence Interval |
() 95% -0.588 to 0.538 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.285 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Month 3 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2682 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.490 | |
| Confidence Interval |
() 95% -1.364 to 0.385 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.439 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Month 3 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4784 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.294 | |
| Confidence Interval |
() 95% -1.116 to 0.528 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.413 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Month 6 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0255 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.661 | |
| Confidence Interval |
() 95% 0.084 to 1.239 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.298 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Month 6 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1591 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.448 | |
| Confidence Interval |
() 95% -0.180 to 1.076 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.314 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
| Title | Pain Interference With Relations With People as Measured by the m-BPI-sf |
|---|---|
| Description | m-BPI-sf questionnaire (7-items) assessed pain interference with functional activities during the past 24 hours. Q5E: Subject response to 'how, during the past 24 hours, pain has interfered with your relations with other people'. Scale: 0 = does not interfere to 10 = completely interferes. |
| Time Frame | Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6 |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT |
| Arm/Group Title | Pregabalin (150 mg) | Pregabalin (300 mg) | Placebo |
|---|---|---|---|
| Arm/Group Description | Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1. | Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1. | Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1. |
| Measure Participants | 86 | 80 | 80 |
| Discharge (n=83, 80, 74) |
1.837
(0.266)
|
1.716
(0.266)
|
2.624
(0.284)
|
| Week 2 (n=86, 78, 80) |
1.566
(0.231)
|
1.370
(0.240)
|
1.671
(0.246)
|
| Week 4 (n=77, 69, 67) |
1.004
(0.215)
|
1.162
(0.222)
|
1.187
(0.238)
|
| Week 6/ET (n=78, 67, 71) |
0.544
(0.171)
|
0.845
(0.184)
|
0.898
(0.185)
|
| Month 3 (n=30, 32, 35) |
0.253
(0.377)
|
0.861
(0.377)
|
1.364
(0.365)
|
| Month 6 (n=31, 25, 27) |
0.802
(0.245)
|
1.060
(0.226)
|
0.626
(0.235)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Discharge | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0359 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.786 | |
| Confidence Interval |
() 95% -1.520 to -0.052 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.372 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Discharge | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0161 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.907 | |
| Confidence Interval |
() 95% -1.644 to -0.170 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.374 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Week 2 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7416 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.105 | |
| Confidence Interval |
() 95% -0.733 to 0.523 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.319 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Week 2 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3527 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.301 | |
| Confidence Interval |
() 95% -0.939 to 0.336 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.324 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Week 4 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5419 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.184 | |
| Confidence Interval |
() 95% -0.776 to 0.409 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.300 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Week 4 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9333 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.026 | |
| Confidence Interval |
() 95% -0.628 to 0.577 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.305 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Week 6/ET | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1420 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.354 | |
| Confidence Interval |
() 95% -0.827 to 0.120 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.240 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Week 6/ET | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8290 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.053 | |
| Confidence Interval |
() 95% -0.535 to 0.429 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.245 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Month 3 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0138 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -1.111 | |
| Confidence Interval |
() 95% -1.989 to -0.233 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.441 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Month 3 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2300 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.503 | |
| Confidence Interval |
() 95% -1.332 to 0.325 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.416 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Month 6 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5151 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.175 | |
| Confidence Interval |
() 95% -0.360 to 0.711 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.268 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Month 6 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1460 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.433 | |
| Confidence Interval |
() 95% -0.155 to 1.022 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.295 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
| Title | Pain Interference With Enjoyment of Life as Measured by the m-BPI-sf |
|---|---|
| Description | m-BPI-sf questionnaire (7-items) assessed pain interference with functional activities during the past 24 hours. Q5G: Subject response to 'how, during the past 24 hours, pain has interfered with your enjoyment of life'. Scale: 0 = does not interfere to 10 = completely interferes. |
| Time Frame | Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6 |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT |
| Arm/Group Title | Pregabalin (150 mg) | Pregabalin (300 mg) | Placebo |
|---|---|---|---|
| Arm/Group Description | Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1. | Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1. | Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1. |
| Measure Participants | 86 | 80 | 80 |
| Discharge (n=83, 80, 74) |
3.487
(0.330)
|
3.769
(0.330)
|
3.744
(0.354)
|
| Week 2 (n=86, 78, 80) |
2.945
(0.313)
|
2.802
(0.325)
|
2.953
(0.334)
|
| Week 4 (n=77, 69, 67) |
2.152
(0.260)
|
2.042
(0.268)
|
1.768
(0.289)
|
| Week 6/ET (n=78, 67, 71) |
1.535
(0.247)
|
1.720
(0.266)
|
1.696
(0.267)
|
| Month 3 (n=30, 32, 35) |
0.944
(0.497)
|
1.467
(0.513)
|
1.368
(0.509)
|
| Month 6 (n=31, 25, 27) |
1.657
(0.404)
|
1.658
(0.367)
|
0.663
(0.389)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Discharge | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5786 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.258 | |
| Confidence Interval |
() 95% -1.170 to 0.655 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.463 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Discharge | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9570 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.025 | |
| Confidence Interval |
() 95% -0.895 to 0.946 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.467 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Week 2 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9860 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.008 | |
| Confidence Interval |
() 95% -0.862 to 0.847 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.434 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Week 2 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7336 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.151 | |
| Confidence Interval |
() 95% -1.021 to 0.720 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.442 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Week 4 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2939 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.384 | |
| Confidence Interval |
() 95% -0.336 to 1.104 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.365 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Week 4 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4615 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.274 | |
| Confidence Interval |
() 95% -0.459 to 1.008 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.372 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Week 6/ET | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6433 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.161 | |
| Confidence Interval |
() 95% -0.845 to 0.523 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.347 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Week 6/ET | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9466 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.024 | |
| Confidence Interval |
() 95% -0.678 to 0.726 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.356 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Month 3 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4967 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.424 | |
| Confidence Interval |
() 95% -1.660 to 0.812 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.621 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Month 3 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8659 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.099 | |
| Confidence Interval |
() 95% -1.060 to 1.257 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.582 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Month 6 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0311 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.994 | |
| Confidence Interval |
() 95% 0.093 to 1.895 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.451 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Month 6 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0441 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.995 | |
| Confidence Interval |
() 95% 0.027 to 1.962 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.485 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
| Title | Pain Interference With General Activity as Measured by the m-BPI-sf |
|---|---|
| Description | m-BPI-sf questionnaire (7-items) assessed pain interference with functional activities during the past 24 hours. Q5A: Subject response to 'how, during the past 24 hours, pain has interfered with your general activity. Scale: 0 = does not interfere to 10 = completely interferes. |
| Time Frame | Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6 |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT |
| Arm/Group Title | Pregabalin (150 mg) | Pregabalin (300 mg) | Placebo |
|---|---|---|---|
| Arm/Group Description | Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1. | Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1. | Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1. |
| Measure Participants | 86 | 80 | 80 |
| Discharge (n=83, 80, 74) |
3.794
(0.317)
|
4.499
(0.315)
|
4.764
(0.336)
|
| Week 2 (n=86, 78, 80) |
3.254
(0.278)
|
3.526
(0.288)
|
3.524
(0.294)
|
| Week 4 (n=77, 69, 67) |
2.470
(0.237)
|
2.417
(0.244)
|
2.427
(0.260)
|
| Week 6/ET (n=78, 67, 71) |
2.109
(0.245)
|
1.902
(0.263)
|
2.028
(0.263)
|
| Month 3 (n=30, 32, 35) |
1.861
(0.505)
|
1.547
(0.507)
|
1.969
(0.492)
|
| Month 6 (n=31, 25, 27) |
1.738
(0.412)
|
1.717
(0.376)
|
1.410
(0.394)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Discharge | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0284 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.969 | |
| Confidence Interval |
() 95% -1.835 to -0.104 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.439 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Discharge | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5516 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.265 | |
| Confidence Interval |
() 95% -1.141 to 0.611 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.444 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Week 2 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4790 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.270 | |
| Confidence Interval |
() 95% -1.020 to 0.480 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.380 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Week 2 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9947 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.003 | |
| Confidence Interval |
() 95% -0.765 to 0.770 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.390 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Week 4 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8943 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.044 | |
| Confidence Interval |
() 95% -0.605 to 0.692 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.329 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Week 4 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9767 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.010 | |
| Confidence Interval |
() 95% -0.674 to 0.654 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.336 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Week 6/ET | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8117 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.081 | |
| Confidence Interval |
() 95% -0.590 to 0.752 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.340 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Week 6/ET | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7216 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.125 | |
| Confidence Interval |
() 95% -0.818 to 0.567 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.351 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Month 3 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8558 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.108 | |
| Confidence Interval |
() 95% -1.286 to 1.070 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.592 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Month 3 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4501 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.422 | |
| Confidence Interval |
() 95% -1.530 to 0.685 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.556 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Month 6 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4682 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.328 | |
| Confidence Interval |
() 95% -0.570 to 1.227 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.450 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Month 6 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5347 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.307 | |
| Confidence Interval |
() 95% -0.675 to 1.289 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.492 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
| Title | Pain Interference With Mood as Measured by the m-BPI-sf |
|---|---|
| Description | m-BPI-sf questionnaire (7-items) assessed pain interference with functional activities during the past 24 hours. Q5B: Subject response to 'how, during the past 24 hours, pain has interfered with your mood'. Scale: 0 = does not interfere to 10 = completely interferes. |
| Time Frame | Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6 |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT |
| Arm/Group Title | Pregabalin (150 mg) | Pregabalin (300 mg) | Placebo |
|---|---|---|---|
| Arm/Group Description | Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1. | Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1. | Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1. |
| Measure Participants | 86 | 80 | 80 |
| Discharge (n=83, 80, 74) |
2.588
(0.292)
|
2.418
(0.291)
|
3.354
(0.310)
|
| Week 2 (n=86, 78, 80) |
2.640
(0.292)
|
2.115
(0.303)
|
2.554
(0.308)
|
| Week 4 (n=77, 69, 67) |
1.590
(0.253)
|
1.511
(0.261)
|
1.530
(0.279)
|
| Week 6/ET (n=78, 67, 71) |
1.053
(0.230)
|
1.171
(0.247)
|
1.325
(0.247)
|
| Month 3 (n=30, 32, 35) |
0.632
(0.328)
|
0.956
(0.339)
|
1.334
(0.322)
|
| Month 6 (n=31, 25, 27) |
1.201
(0.326)
|
0.832
(0.297)
|
0.369
(0.313)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Discharge | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0613 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.765 | |
| Confidence Interval |
() 95% -1.568 to 0.037 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.407 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Discharge | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0230 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.936 | |
| Confidence Interval |
() 95% -1.741 to -0.130 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.409 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Week 2 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8306 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.086 | |
| Confidence Interval |
() 95% -0.703 to 0.875 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.400 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Week 2 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2814 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.439 | |
| Confidence Interval |
() 95% -1.242 to 0.363 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.407 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Week 4 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8637 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.061 | |
| Confidence Interval |
() 95% -0.636 to 0.757 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.353 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Week 4 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9585 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.019 | |
| Confidence Interval |
() 95% -0.727 to 0.689 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.359 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Week 6/ET | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3975 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.272 | |
| Confidence Interval |
() 95% -0.906 to 0.361 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.321 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Week 6/ET | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6386 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.154 | |
| Confidence Interval |
() 95% -0.799 to 0.491 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.327 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Month 3 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0813 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.702 | |
| Confidence Interval |
() 95% -1.493 to 0.089 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.397 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Month 3 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3100 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.378 | |
| Confidence Interval |
() 95% -1.114 to 0.358 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.370 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Month 6 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0231 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.831 | |
| Confidence Interval |
() 95% 0.118 to 1.545 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.357 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Month 6 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2367 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.463 | |
| Confidence Interval |
() 95% -0.311 to 1.237 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.388 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
| Title | Pain Interference With Walking Ability as Measured by the m-BPI-sf |
|---|---|
| Description | m-BPI-sf questionnaire (7-items) assessed pain interference with functional activities during the past 24 hours. Q5C: Subject response to 'how, during the past 24 hours, pain has interfered with your walking ability'. Scale: 0 = does not interfere to 10 = completely interferes. |
| Time Frame | Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6 |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT |
| Arm/Group Title | Pregabalin (150 mg) | Pregabalin (300 mg) | Placebo |
|---|---|---|---|
| Arm/Group Description | Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1. | Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1. | Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1. |
| Measure Participants | 86 | 80 | 80 |
| Discharge (n=83, 80, 74) |
4.918
(0.320)
|
4.728
(0.319)
|
4.982
(0.342)
|
| Week 2 (n=86, 78, 80) |
3.297
(0.278)
|
3.344
(0.289)
|
3.425
(0.296)
|
| Week 4 (n=77, 69, 67) |
2.646
(0.259)
|
2.108
(0.267)
|
2.442
(0.286)
|
| Week 6/ET (n=78, 67, 71) |
2.004
(0.237)
|
1.886
(0.254)
|
1.742
(0.256)
|
| Month 3 (n=30, 32, 35) |
1.439
(0.419)
|
1.907
(0.434)
|
1.928
(0.414)
|
| Month 6 (n=31, 25, 27) |
1.573
(0.322)
|
1.391
(0.293)
|
1.126
(0.308)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Discharge | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8868 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.064 | |
| Confidence Interval |
() 95% -0.947 to 0.820 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.448 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Discharge | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5733 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.254 | |
| Confidence Interval |
() 95% -1.142 to 0.634 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.450 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Week 2 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7385 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.128 | |
| Confidence Interval |
() 95% -0.884 to 0.628 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.384 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Week 2 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8353 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.081 | |
| Confidence Interval |
() 95% -0.849 to 0.687 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.390 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Week 4 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5737 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.204 | |
| Confidence Interval |
() 95% -0.510 to 0.918 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.362 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Week 4 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3640 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.335 | |
| Confidence Interval |
() 95% -1.060 to 0.391 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.368 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Week 6/ET | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4315 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.262 | |
| Confidence Interval |
() 95% -0.393 to 0.917 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.332 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Week 6/ET | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6727 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.143 | |
| Confidence Interval |
() 95% -0.525 to 0.812 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.339 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Month 3 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3361 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.489 | |
| Confidence Interval |
() 95% -1.496 to 0.517 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.505 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Month 3 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9634 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.022 | |
| Confidence Interval |
() 95% -0.955 to 0.912 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.469 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Month 6 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2098 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.446 | |
| Confidence Interval |
() 95% -0.257 to 1.150 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.352 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Month 6 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4900 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.265 | |
| Confidence Interval |
() 95% -0.497 to 1.027 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.382 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
| Title | Pain Interference With Normal Work as Measured by the m-BPI-sf |
|---|---|
| Description | m-BPI-sf questionnaire (7-items) assessed pain interference with functional activities during the past 24 hours. Q5D: Subject response to 'how, during the past 24 hours, pain has interfered with your normal work (work outside the home and housework)'. Scale: 0 = does not interfere to 10 = completely interferes. |
| Time Frame | Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6 |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT |
| Arm/Group Title | Pregabalin (150 mg) | Pregabalin (300 mg) | Placebo |
|---|---|---|---|
| Arm/Group Description | Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1. | Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1. | Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1. |
| Measure Participants | 86 | 78 | 79 |
| Discharge (n=82, 77, 72) |
4.879
(0.390)
|
4.738
(0.395)
|
4.873
(0.418)
|
| Week 2 (n=86, 78, 79) |
4.010
(0.335)
|
3.539
(0.347)
|
3.831
(0.355)
|
| Week 4 (n=77, 69, 67) |
2.833
(0.275)
|
2.500
(0.285)
|
2.895
(0.305)
|
| Week 6/ET (n=78, 67, 71) |
2.133
(0.269)
|
2.152
(0.291)
|
2.040
(0.291)
|
| Month 3 (n=30, 32, 35) |
1.797
(0.510)
|
1.731
(0.520)
|
2.264
(0.507)
|
| Month 6 (n=31, 25, 27) |
1.627
(0.288)
|
1.349
(0.263)
|
1.029
(0.276)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Discharge | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9912 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.006 | |
| Confidence Interval |
() 95% -1.070 to 1.082 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.546 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Discharge | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8076 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.135 | |
| Confidence Interval |
() 95% -1.227 to 0.957 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.554 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Week 2 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6978 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.179 | |
| Confidence Interval |
() 95% -0.727 to 1.085 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.460 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Week 2 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5344 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.293 | |
| Confidence Interval |
() 95% -1.219 to 0.634 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.470 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Week 4 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8721 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.062 | |
| Confidence Interval |
() 95% -0.819 to 0.695 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.384 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Week 4 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3179 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.395 | |
| Confidence Interval |
() 95% -1.173 to 0.383 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.394 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Week 6/ET | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8037 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.094 | |
| Confidence Interval |
() 95% -0.648 to 0.835 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.376 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Week 6/ET | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7731 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.113 | |
| Confidence Interval |
() 95% -0.656 to 0.881 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.390 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Month 3 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4461 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.468 | |
| Confidence Interval |
() 95% -1.684 to 0.748 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.611 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Month 3 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3568 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.533 | |
| Confidence Interval |
() 95% -1.679 to 0.612 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.575 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Month 6 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0623 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.598 | |
| Confidence Interval |
() 95% -0.032 to 1.227 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.315 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Month 6 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3529 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.320 | |
| Confidence Interval |
() 95% -0.364 to 1.005 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.343 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
| Title | Pain Interference With Sleep as Measured by the m-BPI-sf |
|---|---|
| Description | m-BPI-sf questionnaire (7-items) assessed pain interference with functional activities during the past 24 hours. Q5F: Subject response to 'how, during the past 24 hours, pain has interfered with your sleep'. Scale: 0 = does not interfere to 10 = completely interferes. |
| Time Frame | Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6 |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT |
| Arm/Group Title | Pregabalin (150 mg) | Pregabalin (300 mg) | Placebo |
|---|---|---|---|
| Arm/Group Description | Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1. | Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1. | Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1. |
| Measure Participants | 86 | 80 | 80 |
| Discharge (n=83, 80, 74) |
2.696
(0.299)
|
2.642
(0.299)
|
3.307
(0.318)
|
| Week 2 (n=86, 78, 80) |
3.139
(0.333)
|
3.015
(0.345)
|
3.587
(0.353)
|
| Week 4 (n=77, 69, 67) |
2.478
(0.278)
|
2.166
(0.288)
|
2.668
(0.308)
|
| Week 6/ET (n=78, 67, 71) |
1.847
(0.275)
|
1.701
(0.296)
|
2.070
(0.296)
|
| Month 3 (n=30, 32, 35) |
1.276
(0.537)
|
0.941
(0.548)
|
1.499
(0.526)
|
| Month 6 (n=31, 25, 27) |
1.963
(0.482)
|
1.005
(0.439)
|
0.778
(0.464)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Discharge | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1448 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.611 | |
| Confidence Interval |
() 95% -1.434 to 0.212 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.417 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Discharge | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1148 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.665 | |
| Confidence Interval |
() 95% -1.494 to 0.163 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.420 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Week 2 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3285 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.448 | |
| Confidence Interval |
() 95% -1.350 to 0.454 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.458 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Week 2 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2205 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.572 | |
| Confidence Interval |
() 95% -1.490 to 0.346 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.466 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Week 4 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6266 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.190 | |
| Confidence Interval |
() 95% -0.958 to 0.578 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.389 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Week 4 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2077 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.502 | |
| Confidence Interval |
() 95% -1.284 to 0.281 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.397 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Week 6/ET | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5626 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.223 | |
| Confidence Interval |
() 95% -0.982 to 0.536 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.385 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Week 6/ET | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3507 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.368 | |
| Confidence Interval |
() 95% -1.145 to 0.408 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.394 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Month 3 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7276 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.224 | |
| Confidence Interval |
() 95% -1.498 to 1.050 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.640 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Month 3 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3530 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.558 | |
| Confidence Interval |
() 95% -1.748 to 0.631 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.598 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Month 6 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0283 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 1.186 | |
| Confidence Interval |
() 95% 0.130 to 2.242 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.529 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Month 6 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6934 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.227 | |
| Confidence Interval |
() 95% -0.918 to 1.372 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.573 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
| Title | Daily and Weekly Worst Pain During the Hospital Stay and Post Discharge Assessed by the Pain Numerical Rating Scale (NRS) |
|---|---|
| Description | Subject rated scale for worst pain over the last 24 hours. Scores ranged from 0 (no pain) to 10 (pain as bad as you can imagine). Weekly mean scores were calculated post-discharge. |
| Time Frame | 12 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours, 168 hours, and 192 hours during the hospital stay, Week 2, Week 4, Week 6/ET |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT. There were not enough subjects with data at 144, 168, and 192 hours to calculate least squares mean values. |
| Arm/Group Title | Pregabalin (150 mg) | Pregabalin (300 mg) | Placebo |
|---|---|---|---|
| Arm/Group Description | Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1. | Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1. | Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1. |
| Measure Participants | 82 | 79 | 74 |
| 12 hours (n=29, 28, 28) |
7.217
(0.597)
|
7.002
(0.649)
|
8.770
(0.635)
|
| 24 hours (n=82, 79, 74) |
7.477
(0.298)
|
7.290
(0.301)
|
7.201
(0.311)
|
| 48 hours (n=78, 82, 75) |
7.041
(0.267)
|
6.740
(0.264)
|
7.079
(0.279)
|
| 72 hours (n=56, 52, 55) |
6.322
(0.333)
|
5.977
(0.350)
|
5.964
(0.343)
|
| 96 hours (n=20, 21, 26) |
6.703
(0.624)
|
4.711
(0.618)
|
6.556
(0.598)
|
| 120 hours (n=5, 3, 9) |
5.915
(0.819)
|
4.346
(1.446)
|
7.056
(0.663)
|
| Week 2 (n=79, 72, 72) |
5.255
(0.209)
|
5.592
(0.223)
|
5.396
(0.229)
|
| Week 4 (n=76, 65, 67) |
4.134
(0.220)
|
4.043
(0.241)
|
4.280
(0.247)
|
| Week 6/ET (n=61, 55, 59) |
3.455
(0.267)
|
3.425
(0.276)
|
3.350
(0.292)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | 12 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0476 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -1.553 | |
| Confidence Interval |
() 95% -3.089 to -0.017 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.770 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | 12 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0237 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -1.768 | |
| Confidence Interval |
() 95% -3.293 to -0.243 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.764 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | 24 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4925 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.276 | |
| Confidence Interval |
() 95% -0.516 to 1.069 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.402 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | 24 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8299 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.089 | |
| Confidence Interval |
() 95% -0.727 to 0.905 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.414 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | 48 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9185 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.038 | |
| Confidence Interval |
() 95% -0.766 to 0.691 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.370 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | 48 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3619 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.339 | |
| Confidence Interval |
() 95% -1.070 to 0.392 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.371 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | 72 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4309 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.358 | |
| Confidence Interval |
() 95% -0.538 to 1.254 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.453 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | 72 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9778 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.013 | |
| Confidence Interval |
() 95% -0.895 to 0.921 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.459 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | 96 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8503 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.147 | |
| Confidence Interval |
() 95% -1.411 to 1.706 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.777 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | 96 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0183 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -1.845 | |
| Confidence Interval |
() 95% -3.364 to -0.326 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.757 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | 120 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2860 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -1.141 | |
| Confidence Interval |
() 95% -3.598 to 1.316 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.956 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | 120 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2040 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -2.710 | |
| Confidence Interval |
() 95% -7.479 to 2.060 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.856 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 13
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Week 2 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6332 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.141 | |
| Confidence Interval |
() 95% -0.722 to 0.440 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.295 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 14
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Week 2 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5183 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.196 | |
| Confidence Interval |
() 95% -0.402 to 0.794 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.303 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 15
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Week 4 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6341 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.146 | |
| Confidence Interval |
() 95% -0.750 to 0.458 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.306 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 16
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Week 4 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4607 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.236 | |
| Confidence Interval |
() 95% -0.868 to 0.395 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.320 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 17
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Week 6/ET | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7499 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.104 | |
| Confidence Interval |
() 95% -0.541 to 0.750 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.327 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 18
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Week 6/ET | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8231 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.075 | |
| Confidence Interval |
() 95% -0.584 to 0.733 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.333 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
| Title | Daily and Weekly Average Pain During the Hospital Stay and Post Discharge Assessed by the Pain NRS |
|---|---|
| Description | Subject rated scale for average pain intensity over the last 24 hours. Scores range from 0 (no pain) to 10 (pain as bad as you can imagine). Weekly mean scores were calculated post-discharge. |
| Time Frame | 12 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours, 168 hours, and 192 hours during the hospital stay, Week 2, Week 4, Week 6/ET |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT. There were not enough subjects with data at 144, 168, and 192 hours to calculate least squares mean values. |
| Arm/Group Title | Pregabalin (150 mg) | Pregabalin (300 mg) | Placebo |
|---|---|---|---|
| Arm/Group Description | Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1. | Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1. | Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1. |
| Measure Participants | 85 | 84 | 82 |
| 12 hours (n=29, 28, 28) |
5.712
(0.550)
|
4.845
(0.593)
|
6.748
(0.600)
|
| 24 hours (n=81, 79, 74) |
4.961
(0.255)
|
4.614
(0.257)
|
4.918
(0.266)
|
| 48 hours (n=78, 82, 75) |
4.518
(0.238)
|
4.309
(0.236)
|
4.515
(0.249)
|
| 72 hours (n=56, 51, 55) |
4.281
(0.280)
|
3.740
(0.298)
|
4.186
(0.290)
|
| 96 hours (n=20, 21, 26) |
4.842
(0.514)
|
3.126
(0.503)
|
4.741
(0.488)
|
| 120 hours (n=5, 3, 9) |
4.211
(1.002)
|
2.940
(1.566)
|
4.287
(0.759)
|
| Week 2 (n=79, 72, 71) |
3.691
(0.186)
|
3.974
(0.198)
|
3.987
(0.206)
|
| Week 4 (n=76, 65, 67) |
2.956
(0.180)
|
2.845
(0.197)
|
3.163
(0.203)
|
| Week 6/ET (n=60, 54, 59) |
2.374
(0.215)
|
2.385
(0.225)
|
2.389
(0.234)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | 12 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1486 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -1.036 | |
| Confidence Interval |
() 95% -2.452 to 0.379 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.709 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | 12 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0089 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -1.903 | |
| Confidence Interval |
() 95% -3.311 to -0.494 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.706 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | 24 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8995 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.044 | |
| Confidence Interval |
() 95% -0.635 to 0.722 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.344 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | 24 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3918 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.303 | |
| Confidence Interval |
() 95% -1.000 to 0.394 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.354 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | 48 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9942 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.002 | |
| Confidence Interval |
() 95% -0.648 to 0.652 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.330 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | 48 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5352 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.206 | |
| Confidence Interval |
() 95% -0.859 to 0.448 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.332 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | 72 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8055 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.094 | |
| Confidence Interval |
() 95% -0.662 to 0.850 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.382 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | 72 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2560 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.446 | |
| Confidence Interval |
() 95% -1.220 to 0.327 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.391 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | 96 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8744 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.102 | |
| Confidence Interval |
() 95% -1.184 to 1.387 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.641 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | 96 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0115 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -1.614 | |
| Confidence Interval |
() 95% -2.851 to -0.378 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.616 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | 120 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9497 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.077 | |
| Confidence Interval |
() 95% -3.047 to 2.893 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.155 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | 120 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5288 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -1.347 | |
| Confidence Interval |
() 95% -6.467 to 3.773 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.992 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 13
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Week 2 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2595 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.296 | |
| Confidence Interval |
() 95% -0.813 to 0.220 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.262 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 14
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Week 2 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9605 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.013 | |
| Confidence Interval |
() 95% -0.546 to 0.519 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.270 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 15
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Week 4 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4107 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.207 | |
| Confidence Interval |
() 95% -0.702 to 0.288 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.251 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 16
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Week 4 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2271 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.318 | |
| Confidence Interval |
() 95% -0.836 to 0.200 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.263 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 17
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Week 6/ET | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9552 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.015 | |
| Confidence Interval |
() 95% -0.535 to 0.506 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.263 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 18
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Week 6/ET | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9899 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.003 | |
| Confidence Interval |
() 95% -0.533 to 0.526 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.268 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
| Title | Current Pain During the Hospital Stay Assessed by the Pain NRS |
|---|---|
| Description | Subject rated scale for average pain intensity over the last 24 hours. Pain was assessed using the question "How much pain do you have right now?" Scores range from 0 (no pain) to 10 (most possible pain). |
| Time Frame | 4, 8, 12, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, 104, 112, 120, 128, 136, 144, 152, 160, 168, 176, 184, and 192 hours during the hospital stay |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT. There were not enough subjects with data at 112, 120, 128, 136, 144, 152, 160, 168, 176, 184, and 192 hours to calculate least squares mean values. |
| Arm/Group Title | Pregabalin (150 mg) | Pregabalin (300 mg) | Placebo |
|---|---|---|---|
| Arm/Group Description | Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1. | Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1. | Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1. |
| Measure Participants | 87 | 88 | 82 |
| 4 hours (n=84, 84, 78) |
4.940
(0.345)
|
3.554
(0.344)
|
4.363
(0.361)
|
| 8 hours (n=82, 79, 75) |
5.083
(0.305)
|
4.529
(0.312)
|
5.119
(0.323)
|
| 12 hours (n=66, 68, 64) |
4.779
(0.385)
|
4.068
(0.375)
|
4.784
(0.376)
|
| 24 hours (n=87, 88, 82) |
4.500
(0.265)
|
4.545
(0.262)
|
4.836
(0.277)
|
| 32 hours (n=79, 78, 69) |
4.450
(0.293)
|
4.507
(0.296)
|
4.345
(0.315)
|
| 40 hours (n=62, 55, 55) |
3.720
(0.401)
|
3.821
(0.412)
|
3.902
(0.408)
|
| 48 hours (n=78, 72, 70) |
4.095
(0.276)
|
4.069
(0.284)
|
3.785
(0.295)
|
| 56 hours (n=62, 56, 57) |
4.015
(0.329)
|
3.358
(0.345)
|
3.760
(0.343)
|
| 64 hours (n=46, 37, 45) |
4.220
(0.458)
|
3.492
(0.480)
|
4.578
(0.423)
|
| 72 hours (n=51, 45, 45) |
3.971
(0.344)
|
3.271
(0.379)
|
3.826
(0.385)
|
| 80 hours (n=19, 24, 24) |
5.312
(0.678)
|
2.403
(0.624)
|
4.285
(0.691)
|
| 88 hours (n=16, 13, 20) |
4.265
(0.714)
|
2.767
(0.803)
|
3.914
(0.730)
|
| 96 hours (n=16, 14, 20) |
3.525
(0.729)
|
2.532
(0.773)
|
2.658
(0.737)
|
| 104 hours (n=7, 3, 7) |
3.501
(0.908)
|
2.680
(1.382)
|
1.829
(0.972)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | 4 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2211 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.578 | |
| Confidence Interval |
() 95% -0.350 to 1.506 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.471 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | 4 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0916 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.809 | |
| Confidence Interval |
() 95% -1.750 to 0.132 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.477 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | 8 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9312 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.036 | |
| Confidence Interval |
() 95% -0.863 to 0.791 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.420 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | 8 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1658 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.591 | |
| Confidence Interval |
() 95% -1.428 to 0.247 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.425 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | 12 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9921 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.005 | |
| Confidence Interval |
() 95% -0.958 to 0.948 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.483 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | 12 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1367 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.715 | |
| Confidence Interval |
() 95% -1.660 to 0.229 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.479 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | 24 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3561 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.336 | |
| Confidence Interval |
() 95% -1.053 to 0.380 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.364 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | 24 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4260 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.291 | |
| Confidence Interval |
() 95% -1.012 to 0.429 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.366 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | 32 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7975 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.105 | |
| Confidence Interval |
() 95% -0.703 to 0.914 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.410 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | 32 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6947 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.162 | |
| Confidence Interval |
() 95% -0.650 to 0.974 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.412 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | 40 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6954 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.182 | |
| Confidence Interval |
() 95% -1.101 to 0.736 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.465 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | 40 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8665 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.081 | |
| Confidence Interval |
() 95% -1.032 to 0.870 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.481 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 13
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | 48 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4216 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.311 | |
| Confidence Interval |
() 95% -0.450 to 1.072 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.386 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 14
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | 48 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4673 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.285 | |
| Confidence Interval |
() 95% -0.487 to 1.056 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.391 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 15
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | 56 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5624 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.255 | |
| Confidence Interval |
() 95% -0.614 to 1.125 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.440 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 16
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | 56 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3705 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.402 | |
| Confidence Interval |
() 95% -1.286 to 0.482 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.448 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 17
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | 64 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4539 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.358 | |
| Confidence Interval |
() 95% -1.302 to 0.586 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.476 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 18
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | 64 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0373 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -1.086 | |
| Confidence Interval |
() 95% -2.107 to -0.065 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.515 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 19
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | 72 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7600 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.146 | |
| Confidence Interval |
() 95% -0.796 to 1.087 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.476 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 20
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | 72 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2506 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.555 | |
| Confidence Interval |
() 95% -1.507 to 0.397 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.481 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 21
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | 80 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2567 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 1.027 | |
| Confidence Interval |
() 95% -0.770 to 2.823 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.895 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 22
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | 80 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0167 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -1.882 | |
| Confidence Interval |
() 95% -3.408 to -0.356 |
|
| Parameter Dispersion |
Type: Standard Deviation Value: 0.760 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 23
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | 88 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6953 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.352 | |
| Confidence Interval |
() 95% -1.456 to 2.159 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.890 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 24
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | 88 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2080 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -1.147 | |
| Confidence Interval |
() 95% -2.962 to 0.668 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.894 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 25
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | 96 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3805 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.867 | |
| Confidence Interval |
() 95% -1.116 to 2.849 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.975 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 26
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | 96 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8900 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.126 | |
| Confidence Interval |
() 95% -1.965 to 1.713 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.905 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 27
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | 104 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1821 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 1.672 | |
| Confidence Interval |
() 95% -1.103 to 4.448 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.080 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 28
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | 104 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6505 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.851 | |
| Confidence Interval |
() 95% -3.693 to 5.395 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.768 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
| Title | Pain-Related Sleep Interference Post Surgery |
|---|---|
| Description | The NRS-Sleep: subject rated 11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]) rating how pain has interfered with sleep during the past 24 hours. Weekly mean scores were calculated post hospital discharge. |
| Time Frame | 24 hours, 48 hours, 72 hours, 96 hours 120 hours, 144 hours, 168 hours, and 192 hours post-surgery, Week 2, Week 4, Week 6/ET |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT. There were not enough subjects with data at 144, 168, and 192 hours to calculate least squares mean values. |
| Arm/Group Title | Pregabalin (150 mg) | Pregabalin (300 mg) | Placebo |
|---|---|---|---|
| Arm/Group Description | Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1. | Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1. | Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1. |
| Measure Participants | 86 | 86 | 81 |
| 24 hours (n=86, 86, 81) |
4.452
(0.359)
|
3.671
(0.364)
|
5.481
(0.376)
|
| 48 hours (n=82, 82, 77) |
3.830
(0.293)
|
3.408
(0.296)
|
4.027
(0.309)
|
| 72 hours (n=59, 58, 59) |
2.926
(0.332)
|
2.609
(0.349)
|
3.645
(0.345)
|
| 96 hours (n=20, 21, 24) |
4.087
(0.539)
|
1.645
(0.522)
|
3.213
(0.563)
|
| 120 hours (n=6, 4, 7) |
3.194
(1.665)
|
7.237
(2.563)
|
1.328
(1.598)
|
| Week 2 (n=80, 73, 71) |
3.837
(0.217)
|
4.128
(0.229)
|
4.256
(0.239)
|
| Week 4 (n=76, 65, 67) |
3.181
(0.216)
|
3.042
(0.236)
|
3.532
(0.241)
|
| Week 6/ET (n=61, 56, 57) |
2.484
(0.261)
|
2.592
(0.265)
|
2.748
(0.284)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | 24 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0388 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -1.029 | |
| Confidence Interval |
() 95% -2.004 to -0.053 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.495 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | 24 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0004 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -1.810 | |
| Confidence Interval |
() 95% -2.798 to -0.822 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.501 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | 48 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6274 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.197 | |
| Confidence Interval |
() 95% -0.995 to 0.601 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.405 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | 48 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1350 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.619 | |
| Confidence Interval |
() 95% -1.432 to 0.194 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.413 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | 72 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1106 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.719 | |
| Confidence Interval |
() 95% -1.605 to 0.166 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.448 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | 72 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0248 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -1.036 | |
| Confidence Interval |
() 95% -1.939 to -0.133 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.457 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | 96 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2335 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.874 | |
| Confidence Interval |
() 95% -0.582 to 2.330 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.725 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | 96 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0258 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -1.568 | |
| Confidence Interval |
() 95% -2.939 to -0.198 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.682 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | 120 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3878 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 1.866 | |
| Confidence Interval |
() 95% -3.207 to 6.939 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.973 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | 120 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1762 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 5.909 | |
| Confidence Interval |
() 95% -3.740 to 15.559 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 3.754 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Discharge | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1754 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.515 | |
| Confidence Interval |
() 95% -1.261 to 0.231 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.379 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Discharge | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1413 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.569 | |
| Confidence Interval |
() 95% -1.329 to 0.191 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.386 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 13
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Week 2 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1731 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.419 | |
| Confidence Interval |
() 95% -1.023 to 0.185 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.306 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 14
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Week 2 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6829 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.128 | |
| Confidence Interval |
() 95% -0.747 to 0.490 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.314 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 15
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Week 4 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2436 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.351 | |
| Confidence Interval |
() 95% -0.943 to 0.241 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.300 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 16
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Week 4 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1190 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.490 | |
| Confidence Interval |
() 95% -1.108 to 0.127 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.313 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 17
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Week 6/ET | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4117 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.264 | |
| Confidence Interval |
() 95% -0.897 to 0.369 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.321 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 18
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Week 6/ET | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6294 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.156 | |
| Confidence Interval |
() 95% -0.794 to 0.482 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.323 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
| Title | Change From Baseline in Visual Analogue Scale for Anxiety (VAS-Anxiety) Score Prior to Surgery |
|---|---|
| Description | VAS-Anxiety was administered to measure pre-operative anxiety. Score: 0 = no anxiety to 100 = worst imaginable anxiety. |
| Time Frame | Day 1, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, and 6 hours prior to surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT. There were not enough subjects with data at 6 hours to calculate least squares mean values. |
| Arm/Group Title | Pregabalin (150 mg) | Pregabalin (300 mg) | Placebo |
|---|---|---|---|
| Arm/Group Description | Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1. | Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1. | Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1. |
| Measure Participants | 83 | 79 | 78 |
| Day 1 (n=83, 79, 78) |
6.133
(2.395)
|
7.103
(2.450)
|
6.992
(2.523)
|
| 1 hour (n=68, 67, 59) |
6.974
(2.787)
|
3.272
(2.805)
|
6.085
(3.013)
|
| 2 hours (n=75, 76, 63) |
3.792
(2.860)
|
6.818
(2.844)
|
6.454
(3.126)
|
| 3 hours (n=52, 58, 63) |
7.477
(3.466)
|
7.588
(3.188)
|
7.313
(3.108)
|
| 4 hours (n=19, 17, 20) |
8.218
(5.803)
|
0.109
(6.150)
|
10.133
(5.527)
|
| 5 hours (n=3, 4, 8) |
71.190
(16.886)
|
29.819
(7.644)
|
-15.145
(6.572)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Day 1 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7958 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.859 | |
| Confidence Interval |
() 95% -7.391 to 5.673 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 3.315 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Day 1 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9733 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.111 | |
| Confidence Interval |
() 95% -6.436 to 6.659 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 3.322 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | 1 hour | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8220 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.889 | |
| Confidence Interval |
() 95% -6.898 to 8.675 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 3.946 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | 1 hour | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4736 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -2.813 | |
| Confidence Interval |
() 95% -10.542 to 4.917 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 3.917 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | 2 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5113 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -2.662 | |
| Confidence Interval |
() 95% -10.639 to 5.316 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 4.045 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | 2 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9266 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.365 | |
| Confidence Interval |
() 95% -7.425 to 8.154 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 3.950 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | 3 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9699 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.164 | |
| Confidence Interval |
() 95% -8.423 to 8.751 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 4.347 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | 3 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9482 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.275 | |
| Confidence Interval |
() 95% -8.085 to 8.635 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 4.232 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | 4 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7969 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -1.915 | |
| Confidence Interval |
() 95% -16.842 to 13.012 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 7.391 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | 4 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1991 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -10.023 | |
| Confidence Interval |
() 95% -25.533 to 5.487 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 7.680 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | 5 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0321 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 86.335 | |
| Confidence Interval |
() 95% 13.976 to 158.693 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 22.737 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | 5 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0353 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 44.964 | |
| Confidence Interval |
() 95% 5.837 to 84.091 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 12.295 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
| Title | Timed Up-and-Go (TUG) |
|---|---|
| Description | TUG: time taken in seconds to rise from a standard arm chair, walk to a line on the floor 3 meters away, turn, return and sit down again. |
| Time Frame | 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, Week 2, Week 4, Week 6/ET |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT. There were not enough subjects with data at 120 (Pregabalin 300 mg only), 144, 168, and 192 hours to calculate least squares mean values. |
| Arm/Group Title | Pregabalin (150 mg) | Pregabalin (300 mg) | Placebo |
|---|---|---|---|
| Arm/Group Description | Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1. | Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1. | Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1. |
| Measure Participants | 78 | 71 | 72 |
| 24 hours (n=45, 47, 46) |
76.153
(10.449)
|
79.973
(8.719)
|
82.964
(10.174)
|
| 48 hours (n=69, 70, 64) |
80.027
(8.601)
|
79.548
(8.111)
|
86.842
(8.927)
|
| 72 hours (n=46, 46, 46) |
66.228
(8.429)
|
68.373
(8.561)
|
80.142
(9.276)
|
| 96 hours (n=14, 14, 22) |
110.780
(45.437)
|
43.021
(36.751)
|
70.271
(37.742)
|
| 120 hours (n=5, 2, 5) |
52.591
(5.102)
|
NA
(NA)
|
34.078
(4.700)
|
| Week 2 (n=78, 71, 72) |
22.322
(2.087)
|
21.332
(2.091)
|
21.678
(2.113)
|
| Week 4 (n=73, 65, 63) |
18.072
(1.537)
|
18.145
(1.527)
|
16.535
(1.563)
|
| Week 6/ET (n=75, 60, 63) |
12.694
(1.226)
|
15.140
(1.437)
|
13.813
(1.408)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | 24 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5736 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -6.812 | |
| Confidence Interval |
() 95% -30.792 to 17.169 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 12.055 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | 24 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8003 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -2.991 | |
| Confidence Interval |
() 95% -26.438 to 20.455 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 11.786 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | 48 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5125 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -6.815 | |
| Confidence Interval |
() 95% -27.369 to 13.740 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 10.371 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | 48 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4773 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -7.294 | |
| Confidence Interval |
() 95% -27.563 to 12.976 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 10.227 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | 72 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2142 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -13.915 | |
| Confidence Interval |
() 95% -36.055 to 8.226 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 11.101 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | 72 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2989 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -11.769 | |
| Confidence Interval |
() 95% -34.197 to 10.659 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 11.245 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | 96 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3829 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 40.510 | |
| Confidence Interval |
() 95% -53.429 to 134.449 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 45.612 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | 96 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5531 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -27.250 | |
| Confidence Interval |
() 95% -120.59 to 66.092 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 45.322 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | 120 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2738 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 18.513 | |
| Confidence Interval |
() 95% -89.376 to 126.402 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 8.491 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Week 2 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7987 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.644 | |
| Confidence Interval |
() 95% -4.343 to 5.630 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.519 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Week 2 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8875 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.346 | |
| Confidence Interval |
() 95% -5.177 to 4.485 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.441 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Week 4 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4319 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 1.537 | |
| Confidence Interval |
() 95% -2.324 to 5.398 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.949 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 13
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Week 4 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4070 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 1.610 | |
| Confidence Interval |
() 95% -2.223 to 5.443 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.935 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 14
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Week 6/ET | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4968 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -1.119 | |
| Confidence Interval |
() 95% -4.371 to 2.133 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.641 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 15
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Week 6/ET | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4270 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 1.327 | |
| Confidence Interval |
() 95% -1.972 to 4.626 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.665 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
| Title | Range of Motion (ROM) Assessment of the Active Flexion of the Surgical Knee |
|---|---|
| Description | The degree of active (patient moving the knee) knee flexion and extension tolerated by each subject was recorded. Active ROM in the sitting position was assessed with a goniometer. |
| Time Frame | 24 hours, 48 hours, 72 hours, 96 hours, and 120 hours post surgery, Week 2, Week 4, Week 6/ET |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT. There were not enough subjects with data at 144, 168, and 192 hours to calculate least squares mean values. |
| Arm/Group Title | Pregabalin (150 mg) | Pregabalin (300 mg) | Placebo |
|---|---|---|---|
| Arm/Group Description | Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1. | Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1. | Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1. |
| Measure Participants | 76 | 78 | 69 |
| 24 hours (n=74, 71, 68) |
54.877
(2.194)
|
60.744
(2.248)
|
55.738
(2.287)
|
| 48 hours (n=76, 78, 67) |
69.981
(1.984)
|
73.370
(1.967)
|
69.178
(2.184)
|
| 72 hours (n=52, 52, 50) |
76.516
(2.274)
|
79.535
(2.348)
|
75.588
(2.406)
|
| 96 hours (n=17, 17, 24) |
78.624
(3.287)
|
79.500
(2.936)
|
74.194
(2.969)
|
| 120 hours (n=6, 3, 6) |
80.694
(4.890)
|
72.694
(7.881)
|
81.765
(5.625)
|
| Week 2 (n=73, 67, 69) |
89.917
(1.589)
|
90.332
(1.656)
|
87.992
(1.711)
|
| Week 4 (n=65, 63, 62) |
98.883
(1.870)
|
102.237
(1.914)
|
96.921
(2.017)
|
| Week 6/ET (n=67, 54, 63) |
105.352
(1.845)
|
106.252
(2.137)
|
103.980
(2.051)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | 24 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7742 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.862 | |
| Confidence Interval |
() 95% -6.775 to 5.052 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.999 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | 24 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0996 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 5.006 | |
| Confidence Interval |
() 95% -0.960 to 10.971 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 3.025 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | 48 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7738 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.803 | |
| Confidence Interval |
() 95% -4.698 to 6.304 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.790 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | 48 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1328 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 4.192 | |
| Confidence Interval |
() 95% -1.284 to 9.669 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.778 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | 72 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7585 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.928 | |
| Confidence Interval |
() 95% -5.027 to 6.882 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 3.012 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | 72 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1900 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 3.946 | |
| Confidence Interval |
() 95% -1.979 to 9.871 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.997 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | 96 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2365 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 4.430 | |
| Confidence Interval |
() 95% -3.004 to 11.865 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 3.693 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | 96 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1616 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 5.306 | |
| Confidence Interval |
() 95% -2.202 to 12.814 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 3.730 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | 120 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8819 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -1.071 | |
| Confidence Interval |
() 95% -17.98 to 15.838 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 6.911 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | 120 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4676 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -9.071 | |
| Confidence Interval |
() 95% -37.70 to 19.558 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 11.700 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Week 2 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3813 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 1.925 | |
| Confidence Interval |
() 95% -2.403 to 6.254 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.195 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Week 2 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2966 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 2.341 | |
| Confidence Interval |
() 95% -2.070 to 6.751 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.236 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 13
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Week 4 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4474 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 1.962 | |
| Confidence Interval |
() 95% -3.122 to 7.046 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.576 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 14
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Week 4 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0416 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 5.316 | |
| Confidence Interval |
() 95% 0.204 to 10.427 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.590 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 15
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Week 6/ET | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5935 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 1.372 | |
| Confidence Interval |
() 95% -3.694 to 6.438 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.566 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 16
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Week 6/ET | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3966 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 2.272 | |
| Confidence Interval |
() 95% -3.006 to 7.551 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.674 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
| Title | ROM Assessment of the Passive Flexion of the Surgical Knee |
|---|---|
| Description | The degree of passive (movement of the knee with the aid of physical therapist or designee) knee flexion and extension tolerated by each subject was recorded. Passive ROM in the sitting position was assessed with a goniometer. |
| Time Frame | 24 hours, 48 hours, 72 hours, 96 hours, and 120 hours post surgery, Week 2, Week 4, Week 6/ET |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT. There were not enough subjects with data at 144, 168, and 192 hours to calculate least squares mean values. |
| Arm/Group Title | Pregabalin (150 mg) | Pregabalin (300 mg) | Placebo |
|---|---|---|---|
| Arm/Group Description | Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1. | Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1. | Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1. |
| Measure Participants | 85 | 84 | 80 |
| 24 hours (n=81, 76, 73) |
66.720
(1.990)
|
71.523
(2.098)
|
64.991
(2.093)
|
| 48 hours (n=78, 80, 70) |
77.714
(1.695)
|
81.322
(1.675)
|
76.813
(1.809)
|
| 72 hours (n=53, 50, 53) |
84.154
(1.952)
|
88.119
(2.041)
|
80.984
(1.971)
|
| 96 hours (n=17, 17, 24) |
86.471
(3.553)
|
91.460
(3.174)
|
80.287
(3.210)
|
| 120 hours (n=5, 3, 6) |
92.160
(1.517)
|
97.160
(2.381)
|
79.218
(1.682)
|
| Week 2 (n=79, 71, 73) |
94.767
(1.520)
|
96.973
(1.606)
|
93.642
(1.647)
|
| Week 4 (n=72, 62, 65) |
104.548
(1.680)
|
107.703
(1.835)
|
101.932
(1.851)
|
| Week 6/ET (n=74, 60, 66) |
110.318
(1.629)
|
111.348
(1.884)
|
108.944
(1.848)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | 24 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5117 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 1.729 | |
| Confidence Interval |
() 95% -3.457 to 6.916 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.631 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | 24 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0154 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 6.532 | |
| Confidence Interval |
() 95% 1.258 to 11.805 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.675 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | 48 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7022 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.901 | |
| Confidence Interval |
() 95% -3.738 to 5.540 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.353 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | 48 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0557 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 4.509 | |
| Confidence Interval |
() 95% -0.110 to 9.129 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.343 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | 72 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2161 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 3.171 | |
| Confidence Interval |
() 95% -1.874 to 8.215 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.552 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | 72 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0058 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 7.135 | |
| Confidence Interval |
() 95% 2.098 to 12.172 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.548 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | 96 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1283 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 6.185 | |
| Confidence Interval |
() 95% -1.853 to 14.223 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 3.993 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | 96 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0080 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 11.173 | |
| Confidence Interval |
() 95% 3.056 to 19.291 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 4.033 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | 120 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0018 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 12.941 | |
| Confidence Interval |
() 95% 7.414 to 18.468 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.150 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | 120 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0038 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 17.941 | |
| Confidence Interval |
() 95% 8.859 to 27.023 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 3.533 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Week 2 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5953 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 1.125 | |
| Confidence Interval |
() 95% -3.045 to 5.296 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.115 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Week 2 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1267 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 3.331 | |
| Confidence Interval |
() 95% -0.952 to 7.613 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.172 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 13
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Week 4 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2647 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 2.617 | |
| Confidence Interval |
() 95% -1.997 to 7.231 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.339 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 14
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Week 4 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0181 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 5.771 | |
| Confidence Interval |
() 95% 0.995 to 10.548 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.421 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 15
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Week 6/ET | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5507 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 1.374 | |
| Confidence Interval |
() 95% -3.161 to 5.910 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.299 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 16
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Week 6/ET | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3164 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 2.404 | |
| Confidence Interval |
() 95% -2.317 to 7.124 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.393 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
| Title | Time From End of Surgery to Meet Hospital Discharge Criteria |
|---|---|
| Description | The analysis was performed by Kaplan-Meier method with log-rank test. |
| Time Frame | time from end of surgery up to 192 hours post surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT |
| Arm/Group Title | Pregabalin (150 mg) | Pregabalin (300 mg) | Placebo |
|---|---|---|---|
| Arm/Group Description | Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1. | Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1. | Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1. |
| Measure Participants | 83 | 84 | 82 |
| Mean (Standard Error) [hours] |
106.802
(6.059)
|
112.966
(7.707)
|
95.531
(3.385)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4365 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4023 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Title | Time From End of Surgery to Actual Discharge |
|---|---|
| Description | The analysis was performed by Kaplan-Meier method with log-rank test. |
| Time Frame | time from end of surgery up to 192 hours post surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT |
| Arm/Group Title | Pregabalin (150 mg) | Pregabalin (300 mg) | Placebo |
|---|---|---|---|
| Arm/Group Description | Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1. | Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1. | Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1. |
| Measure Participants | 78 | 82 | 75 |
| Mean (Standard Error) [hours] |
75.709
(2.798)
|
73.906
(2.404)
|
78.451
(2.715)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4024 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1910 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Title | Satisfaction With Current Pain Medication Measured by the Pain Treatment Satisfaction Scale (PTSS) |
|---|---|
| Description | Measure of subject satisfaction with treatment for acute or chronic pain. Response range: 1 (strongly agree) to 5 (strongly disagree). Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment. |
| Time Frame | Discharge, Week 2, Week 4, Week 6/ET |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT. |
| Arm/Group Title | Pregabalin (150 mg) | Pregabalin (300 mg) | Placebo |
|---|---|---|---|
| Arm/Group Description | Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1. | Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1. | Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1. |
| Measure Participants | 84 | 84 | 80 |
| Discharge (n=84, 84, 80) |
79.897
(1.802)
|
80.706
(1.809)
|
77.550
(1.890)
|
| Week 2 (n=22, 20, 18) |
85.274
(4.689)
|
85.294
(4.782)
|
80.148
(5.201)
|
| Week 4 (n=30, 27, 19) |
83.608
(3.012)
|
84.728
(3.010)
|
81.572
(3.765)
|
| Week 6/ET (n=32, 31, 40) |
74.618
(3.922)
|
76.925
(4.187)
|
71.962
(4.044)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Discharge | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3483 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 2.347 | |
| Confidence Interval |
() 95% -2.573 to 7.268 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.497 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Discharge | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2078 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 3.155 | |
| Confidence Interval |
() 95% -1.766 to 8.077 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.498 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Week 2 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4299 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 5.126 | |
| Confidence Interval |
() 95% -7.836 to 18.088 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 6.436 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Week 2 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4482 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 5.146 | |
| Confidence Interval |
() 95% -8.400 to 18.693 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 6.726 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Week 4 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6472 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 2.036 | |
| Confidence Interval |
() 95% -6.818 to 10.890 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 4.426 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Week 4 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4992 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 3.156 | |
| Confidence Interval |
() 95% -6.129 to 12.442 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 4.642 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Week 6/ET | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6072 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 2.656 | |
| Confidence Interval |
() 95% -7.578 to 12.891 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 5.149 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Week 6/ET | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3146 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 4.963 | |
| Confidence Interval |
() 95% -4.789 to 14.714 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 4.906 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
| Title | Satisfaction With Medication Characteristics Measured by the PTSS |
|---|---|
| Description | Measure of subject satisfaction with treatment for acute or chronic pain. Response range: 1 (strongly agree) to 5 (strongly disagree). Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment. |
| Time Frame | Discharge, Week 2, Week 4, Week 6/ET |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT. |
| Arm/Group Title | Pregabalin (150 mg) | Pregabalin (300 mg) | Placebo |
|---|---|---|---|
| Arm/Group Description | Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1. | Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1. | Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1. |
| Measure Participants | 84 | 84 | 80 |
| Discharge (n=84, 84, 80) |
85.733
(1.679)
|
85.732
(1.685)
|
81.556
(1.761)
|
| Week 2 (n=22, 20, 18) |
91.880
(4.676)
|
87.869
(4.769)
|
84.583
(5.187)
|
| Week 4 (n=30, 27, 19) |
88.492
(2.693)
|
90.571
(2.691)
|
84.323
(3.366)
|
| Week 6/ET (n=32, 31, 40) |
82.339
(3.729)
|
84.571
(3.980)
|
76.908
(3.845)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Discharge | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0739 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 4.177 | |
| Confidence Interval |
() 95% -0.407 to 8.760 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.326 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Discharge | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0740 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 4.176 | |
| Confidence Interval |
() 95% -0.409 to 8.761 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.327 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Week 2 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2615 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 7.298 | |
| Confidence Interval |
() 95% -5.628 to 20.224 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 6.418 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Week 2 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6266 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 3.286 | |
| Confidence Interval |
() 95% -10.22 to 16.795 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 6.707 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Week 4 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2963 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 4.170 | |
| Confidence Interval |
() 95% -3.747 to 12.086 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 3.958 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Week 4 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1375 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 6.248 | |
| Confidence Interval |
() 95% -2.054 to 14.550 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 4.151 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Week 6/ET | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2703 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 5.431 | |
| Confidence Interval |
() 95% -4.298 to 15.161 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 4.895 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Week 6/ET | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1040 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 7.663 | |
| Confidence Interval |
() 95% -1.607 to 16.933 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 4.664 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
| Title | Satisfaction With Medication Efficacy Measured by the PTSS |
|---|---|
| Description | Measure of subject satisfaction with treatment for acute or chronic pain. Response range: 1 (strongly agree) to 5 (strongly disagree). Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment. |
| Time Frame | Discharge, Week 2, Week 4, Week 6/ET |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT. |
| Arm/Group Title | Pregabalin (150 mg) | Pregabalin (300 mg) | Placebo |
|---|---|---|---|
| Arm/Group Description | Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1. | Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1. | Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1. |
| Measure Participants | 84 | 84 | 80 |
| Discharge (n=84, 84, 80) |
74.156
(2.276)
|
75.705
(2.284)
|
73.577
(2.387)
|
| Week 2 (n=22, 20, 18) |
78.669
(6.010)
|
82.724
(6.129)
|
75.713
(6.666)
|
| Week 4 (n=30, 27, 19) |
78.723
(3.811)
|
78.886
(3.808)
|
78.823
(4.763)
|
| Week 6/ET (n=32, 31, 40) |
66.887
(4.958)
|
69.367
(5.292)
|
67.015
(5.112)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Discharge | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8545 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.579 | |
| Confidence Interval |
() 95% -5.635 to 6.793 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 3.154 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Discharge | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5006 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 2.128 | |
| Confidence Interval |
() 95% -4.088 to 8.344 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 3.155 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Week 2 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7217 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 2.956 | |
| Confidence Interval |
() 95% -13.66 to 19.569 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 8.248 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Week 2 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4203 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 7.011 | |
| Confidence Interval |
() 95% -10.35 to 24.372 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 8.620 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Week 4 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9859 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.100 | |
| Confidence Interval |
() 95% -11.30 to 11.102 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 5.600 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Week 4 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9915 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.063 | |
| Confidence Interval |
() 95% -11.68 to 11.811 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 5.873 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Week 6/ET | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9843 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.128 | |
| Confidence Interval |
() 95% -13.06 to 12.808 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 6.508 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Week 6/ET | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7055 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 2.351 | |
| Confidence Interval |
() 95% -9.974 to 14.677 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 6.201 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
| Title | Overall Satisfaction Measured by the PTSS |
|---|---|
| Description | Measure of subject satisfaction with treatment for acute or chronic pain. Response range: 1 (strongly agree) to 5 (strongly disagree). Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment. |
| Time Frame | Discharge, Week 2, Week 4, and Week 6/ET |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT. |
| Arm/Group Title | Pregabalin (150 mg) | Pregabalin (300 mg) | Placebo |
|---|---|---|---|
| Arm/Group Description | Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1. | Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1. | Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1. |
| Measure Participants | 12 | 17 | 15 |
| Discharge (n=12, 17, 15) |
1.845
(0.247)
|
1.654
(0.202)
|
1.821
(0.219)
|
| Week 2 (n=6, 4, 4) |
2.333
(0.827)
|
1.667
(0.675)
|
1.833
(0.893)
|
| Week 4 (n=4, 3, 4) |
1.149
(0.615)
|
2.433
(0.679)
|
2.478
(0.629)
|
| Week 6/ET (n=2, 5, 6) |
1.526
(1.346)
|
4.174
(0.784)
|
3.878
(0.765)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Discharge | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9405 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.024 | |
| Confidence Interval |
() 95% -0.614 to 0.661 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.315 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Discharge | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5641 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.167 | |
| Confidence Interval |
() 95% -0.749 to 0.415 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.287 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Week 2 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5226 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.500 | |
| Confidence Interval |
() 95% -1.181 to 2.181 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.755 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Week 2 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8557 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.167 | |
| Confidence Interval |
() 95% -2.156 to 1.823 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.893 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Week 4 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1925 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -1.328 | |
| Confidence Interval |
() 95% -3.596 to 0.940 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.882 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Week 4 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9654 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.045 | |
| Confidence Interval |
() 95% -2.568 to 2.479 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.982 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Week 6/ET | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2350 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -2.352 | |
| Confidence Interval |
() 95% -6.712 to 2.008 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.782 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Week 6/ET | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7420 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.296 | |
| Confidence Interval |
() 95% -1.806 to 2.399 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.859 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
| Title | Overall Pain Relief Measured by the PTSS |
|---|---|
| Description | Measure of subject satisfaction with treatment for acute or chronic pain. Response range: 1 (strongly agree) to 5 (strongly disagree). Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment. |
| Time Frame | Discharge, Week 2, Week 4, and Week 6/ET |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT |
| Arm/Group Title | Pregabalin (150 mg) | Pregabalin (300 mg) | Placebo |
|---|---|---|---|
| Arm/Group Description | Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1. | Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1. | Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1. |
| Measure Participants | 12 | 17 | 15 |
| Discharge (n=12, 17, 15) |
2.260
(0.258)
|
1.696
(0.211)
|
2.051
(0.229)
|
| Week 2 (n=6, 4, 4) |
2.333
(0.827)
|
1.667
(0.675)
|
1.833
(0.893)
|
| Week 4 (n=4, 3, 4) |
1.418
(0.713)
|
2.612
(0.788)
|
2.537
(0.730)
|
| Week 6/ET (n=2, 5, 6) |
2.067
(1.403)
|
4.233
(0.817)
|
3.900
(0.797)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Discharge | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5299 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.208 | |
| Confidence Interval |
() 95% -0.458 to 0.874 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.329 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Discharge | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2442 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.355 | |
| Confidence Interval |
() 95% -0.964 to 0.253 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.300 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Week 2 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5226 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.500 | |
| Confidence Interval |
() 95% -1.181 to 2.181 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.755 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Week 2 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8557 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.167 | |
| Confidence Interval |
() 95% -2.156 to 1.823 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.893 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Week 4 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3240 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -1.119 | |
| Confidence Interval |
() 95% -3.751 to 1.512 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.024 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Week 4 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9503 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.075 | |
| Confidence Interval |
() 95% -2.853 to 3.003 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.139 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Week 6/ET | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3618 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -1.833 | |
| Confidence Interval |
() 95% -6.379 to 2.712 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.858 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Week 6/ET | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7226 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.333 | |
| Confidence Interval |
() 95% -1.859 to 2.525 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.896 |
|
| Estimation Comments | Mean difference (final values) = Least squares mean difference | |
| Title | Number of Subjects With Global Evaluation of Study Medication Scores |
|---|---|
| Description | The Global Evaluation of Study Medication is a subject-administered single item instrument that records the subject's overall impression (global evaluation) of the study medication by asking the following question: how would you rate the study medication you received for pain? The subject chooses based on a scale of 1 (poor), 2 (fair), 3 (good), or 4 (excellent). |
| Time Frame | Discharge, Week 2, Week 4, and Week 6/ET |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT |
| Arm/Group Title | Pregabalin (150 mg) | Pregabalin (300 mg) | Placebo |
|---|---|---|---|
| Arm/Group Description | Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1. | Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1. | Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1. |
| Measure Participants | 85 | 84 | 78 |
| Discharge, Excellent (n=85, 84, 78) |
31
31.6%
|
27
28.1%
|
19
19.4%
|
| Discharge, Good (n=85, 84, 78) |
31
31.6%
|
46
47.9%
|
39
39.8%
|
| Discharge, Fair (n=85, 84, 78) |
14
14.3%
|
6
6.3%
|
12
12.2%
|
| Discharge, Poor (n=85, 84, 78) |
9
9.2%
|
5
5.2%
|
8
8.2%
|
| Week 2, Excellent (n=22, 20, 18) |
6
6.1%
|
10
10.4%
|
5
5.1%
|
| Week 2, Good (n=22, 20, 18) |
11
11.2%
|
4
4.2%
|
9
9.2%
|
| Week 2, Fair (n=22, 20, 18) |
3
3.1%
|
4
4.2%
|
1
1%
|
| Week 2, Poor (n=22, 20, 18) |
2
2%
|
2
2.1%
|
3
3.1%
|
| Week 4, Excellent (n=30, 27, 19) |
13
13.3%
|
9
9.4%
|
7
7.1%
|
| Week 4, Good (n=30, 27, 19) |
11
11.2%
|
12
12.5%
|
8
8.2%
|
| Week 4, Fair (n=30, 27, 19) |
4
4.1%
|
3
3.1%
|
3
3.1%
|
| Week 4, Poor (n=30, 27, 19) |
2
2%
|
3
3.1%
|
1
1%
|
| Week 6/ET, Excellent (n=32, 31, 40) |
3
3.1%
|
7
7.3%
|
5
5.1%
|
| Week 6/ET, Good (n=32, 31, 40) |
17
17.3%
|
9
9.4%
|
19
19.4%
|
| Week 6/ET, Fair (n=32, 31, 40) |
6
6.1%
|
5
5.2%
|
7
7.1%
|
| Week 6/ET, Poor (n=32, 31, 40) |
6
6.1%
|
10
10.4%
|
9
9.2%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Discharge | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2473 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Discharge | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0239 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Week 2 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6118 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Week 2 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6730 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Week 4 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5954 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Week 4 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7784 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Week 6/ET | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7293 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Week 6/ET | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5202 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
| Title | Number of Subjects With Persistent Pain Based on 11-Point Verbal Rating Scale (VRS) |
|---|---|
| Description | The presence of persistent pain was evaluated on the 11-point VRS. The subject answered the question: how much pain did you experience in the last 24 hours in your operated knee? A zero score of VRS was the only number considered as a "no." Any positive score (1-10) of VRS was consider as "yes." |
| Time Frame | Month 3, Month 6 (phone call) |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT |
| Arm/Group Title | Pregabalin (150 mg) | Pregabalin (300 mg) | Placebo |
|---|---|---|---|
| Arm/Group Description | Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1. | Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1. | Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1. |
| Measure Participants | 65 | 59 | 61 |
| Month 3, Yes (n=65, 59, 61) |
22
22.4%
|
22
22.9%
|
27
27.6%
|
| Month 3, No (n=65, 59, 61) |
43
43.9%
|
37
38.5%
|
34
34.7%
|
| Month 6, Yes (n=64, 62, 61) |
19
19.4%
|
15
15.6%
|
14
14.3%
|
| Month 6, No (n=64, 62, 61) |
45
45.9%
|
47
49%
|
47
48%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Month 3 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1509 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Month 3 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3822 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (150 mg), Placebo |
|---|---|---|
| Comments | Month 6 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2825 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (300 mg), Placebo |
|---|---|---|
| Comments | Month 6 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7733 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
| Title | Neuropathic Pain Symptom Inventory (NPSI) |
|---|---|
| Description | NPSI: subject rated questionnaire to evaluate 5 dimensions of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia). Includes 10 descriptors ranging from 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each relevant dimension. Total score is calculated as the sum of scores of the 10 descriptors, range: 0-100. Higher score indicates greater intensity of pain. |
| Time Frame | Month 3, Month 6 (phone call) |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT |
| Arm/Group Title | Pregabalin (150 mg) | Pregabalin (300 mg) | Placebo |
|---|---|---|---|
| Arm/Group Description | Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1. | Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1. | Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1. |
| Measure Participants | 23 | 24 | 29 |
| Burning Spontaneous Pain, Month 3, (n=23, 24, 29) |
1.348
(2.479)
|
0.792
(2.085)
|
0.828
(1.947)
|
| Burning Spontaneous Pain, Month 6, (n=22, 15, 15) |
1.091
(2.114)
|
1.400
(2.324)
|
0.667
(1.113)
|
| Pressing Spontaneous Pain, Month 3, (n=23, 24, 29) |
1.457
(2.083)
|
0.958
(1.574)
|
0.948
(1.496)
|
| Pressing Spontaneous Pain, Month 6, (n=22, 15, 15) |
1.409
(2.158)
|
1.333
(1.655)
|
0.633
(1.445)
|
| Paroxysmal Pain, Month 3, (n=23, 24, 29) |
0.804
(1.042)
|
1.688
(2.417)
|
1.086
(1.909)
|
| Paroxysmal Pain, Month 6, (n=22, 15, 15) |
1.205
(2.711)
|
1.133
(2.175)
|
0.533
(1.246)
|
| Evoked Pain, Month 3, (n=23, 24, 29) |
1.174
(1.700)
|
1.319
(2.004)
|
0.931
(1.344)
|
| Evoked Pain, Month 6, (n=22, 15, 15) |
0.636
(0.937)
|
1.667
(2.402)
|
0.711
(1.298)
|
| Paresthesia/Dysesthesia, Month 3, (n=23, 24, 29) |
0.848
(1.473)
|
0.604
(1.406)
|
0.690
(1.160)
|
| Paresthesia/Dysesthesia, Month 6, (n=22, 15, 15) |
0.773
(1.674)
|
0.500
(1.086)
|
0.033
(0.129)
|
| Total Score, Month 3, (n=23, 24, 29) |
0.058
(0.061)
|
0.055
(0.075)
|
0.045
(0.059)
|
| Total Score, Month 6, (n=22, 15, 15) |
0.051
(0.074)
|
0.061
(0.078)
|
0.027
(0.036)
|
Adverse Events
| Time Frame | ||||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||
| Arm/Group Title | Pregabalin (150 mg) | Pregabalin (300 mg) | Placebo | |||
| Arm/Group Description | Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1. | Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1. | Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1. | |||
All Cause Mortality |
||||||
| Pregabalin (150 mg) | Pregabalin (300 mg) | Placebo | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
| Pregabalin (150 mg) | Pregabalin (300 mg) | Placebo | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 11/98 (11.2%) | 11/96 (11.5%) | 5/98 (5.1%) | |||
| Cardiac disorders | ||||||
| Cardiac failure congestive | 0/98 (0%) | 1/96 (1%) | 0/98 (0%) | |||
| General disorders | ||||||
| Chest pain | 0/98 (0%) | 0/96 (0%) | 1/98 (1%) | |||
| Oedema peripheral | 1/98 (1%) | 0/96 (0%) | 0/98 (0%) | |||
| Pyrexia | 1/98 (1%) | 0/96 (0%) | 0/98 (0%) | |||
| Hepatobiliary disorders | ||||||
| Porcelain gallbladder | 0/98 (0%) | 1/96 (1%) | 0/98 (0%) | |||
| Immune system disorders | ||||||
| Anaphylactic reaction | 0/98 (0%) | 1/96 (1%) | 0/98 (0%) | |||
| Infections and infestations | ||||||
| Cellulitis | 1/98 (1%) | 0/96 (0%) | 0/98 (0%) | |||
| Urinary tract infection | 0/98 (0%) | 0/96 (0%) | 1/98 (1%) | |||
| Injury, poisoning and procedural complications | ||||||
| Device dislocation | 1/98 (1%) | 0/96 (0%) | 0/98 (0%) | |||
| Fall | 2/98 (2%) | 0/96 (0%) | 0/98 (0%) | |||
| Joint injury | 1/98 (1%) | 0/96 (0%) | 0/98 (0%) | |||
| Wound dehiscence | 0/98 (0%) | 0/96 (0%) | 1/98 (1%) | |||
| Investigations | ||||||
| Bacterial culture positive | 0/98 (0%) | 0/96 (0%) | 1/98 (1%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| Arthralgia | 1/98 (1%) | 0/96 (0%) | 0/98 (0%) | |||
| Haemarthrosis | 0/98 (0%) | 1/96 (1%) | 0/98 (0%) | |||
| Joint range of motion decreased | 1/98 (1%) | 1/96 (1%) | 0/98 (0%) | |||
| Nervous system disorders | ||||||
| Cerebrovascular accident | 1/98 (1%) | 0/96 (0%) | 0/98 (0%) | |||
| Psychiatric disorders | ||||||
| Alcohol withdrawal syndrome | 0/98 (0%) | 0/96 (0%) | 1/98 (1%) | |||
| Depression | 0/98 (0%) | 1/96 (1%) | 0/98 (0%) | |||
| Renal and urinary disorders | ||||||
| Renal failure acute | 0/98 (0%) | 0/96 (0%) | 1/98 (1%) | |||
| Urinary retention | 1/98 (1%) | 0/96 (0%) | 0/98 (0%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| Pulmonary embolism | 1/98 (1%) | 3/96 (3.1%) | 0/98 (0%) | |||
| Respiratory depression | 0/98 (0%) | 0/96 (0%) | 1/98 (1%) | |||
| Surgical and medical procedures | ||||||
| Muscle flap operation | 0/98 (0%) | 0/96 (0%) | 1/98 (1%) | |||
| Vascular disorders | ||||||
| Deep vein thrombosis | 0/98 (0%) | 2/96 (2.1%) | 0/98 (0%) | |||
| Haematoma | 1/98 (1%) | 0/96 (0%) | 1/98 (1%) | |||
| Hypotension | 1/98 (1%) | 1/96 (1%) | 0/98 (0%) | |||
| Thrombosed varicose vein | 1/98 (1%) | 0/96 (0%) | 0/98 (0%) | |||
| Thrombosis | 1/98 (1%) | 0/96 (0%) | 0/98 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| Pregabalin (150 mg) | Pregabalin (300 mg) | Placebo | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 76/98 (77.6%) | 76/96 (79.2%) | 81/98 (82.7%) | |||
| Blood and lymphatic system disorders | ||||||
| Anaemia | 6/98 (6.1%) | 3/96 (3.1%) | 9/98 (9.2%) | |||
| Haemorrhagic anaemia | 4/98 (4.1%) | 3/96 (3.1%) | 4/98 (4.1%) | |||
| Eye disorders | ||||||
| Vision blurred | 0/98 (0%) | 7/96 (7.3%) | 0/98 (0%) | |||
| Gastrointestinal disorders | ||||||
| Constipation | 24/98 (24.5%) | 12/96 (12.5%) | 30/98 (30.6%) | |||
| Diarrhoea | 1/98 (1%) | 4/96 (4.2%) | 3/98 (3.1%) | |||
| Dry mouth | 2/98 (2%) | 4/96 (4.2%) | 1/98 (1%) | |||
| Dyspepsia | 2/98 (2%) | 3/96 (3.1%) | 5/98 (5.1%) | |||
| Nausea | 29/98 (29.6%) | 31/96 (32.3%) | 51/98 (52%) | |||
| Vomiting | 14/98 (14.3%) | 15/96 (15.6%) | 25/98 (25.5%) | |||
| General disorders | ||||||
| Fatigue | 20/98 (20.4%) | 15/96 (15.6%) | 19/98 (19.4%) | |||
| Oedema | 1/98 (1%) | 4/96 (4.2%) | 2/98 (2%) | |||
| Oedema peripheral | 7/98 (7.1%) | 9/96 (9.4%) | 11/98 (11.2%) | |||
| Pyrexia | 13/98 (13.3%) | 16/96 (16.7%) | 5/98 (5.1%) | |||
| Infections and infestations | ||||||
| Urinary tract infection | 4/98 (4.1%) | 2/96 (2.1%) | 4/98 (4.1%) | |||
| Injury, poisoning and procedural complications | ||||||
| Anaemia postoperative | 7/98 (7.1%) | 7/96 (7.3%) | 3/98 (3.1%) | |||
| Postoperative fever | 2/98 (2%) | 3/96 (3.1%) | 4/98 (4.1%) | |||
| Procedural nausea | 5/98 (5.1%) | 2/96 (2.1%) | 1/98 (1%) | |||
| Procedural pain | 6/98 (6.1%) | 7/96 (7.3%) | 5/98 (5.1%) | |||
| Investigations | ||||||
| Body temperature increased | 4/98 (4.1%) | 5/96 (5.2%) | 1/98 (1%) | |||
| Haematocrit decreased | 5/98 (5.1%) | 4/96 (4.2%) | 3/98 (3.1%) | |||
| Haemoglobin decreased | 6/98 (6.1%) | 5/96 (5.2%) | 3/98 (3.1%) | |||
| Metabolism and nutrition disorders | ||||||
| Hypokalaemia | 1/98 (1%) | 3/96 (3.1%) | 5/98 (5.1%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| Arthralgia | 0/98 (0%) | 2/96 (2.1%) | 4/98 (4.1%) | |||
| Back pain | 6/98 (6.1%) | 2/96 (2.1%) | 1/98 (1%) | |||
| Joint swelling | 0/98 (0%) | 3/96 (3.1%) | 4/98 (4.1%) | |||
| Muscular weakness | 0/98 (0%) | 4/96 (4.2%) | 0/98 (0%) | |||
| Pain in extremity | 7/98 (7.1%) | 2/96 (2.1%) | 6/98 (6.1%) | |||
| Nervous system disorders | ||||||
| Disturbance in attention | 10/98 (10.2%) | 11/96 (11.5%) | 11/98 (11.2%) | |||
| Dizziness | 20/98 (20.4%) | 25/96 (26%) | 16/98 (16.3%) | |||
| Headache | 7/98 (7.1%) | 3/96 (3.1%) | 9/98 (9.2%) | |||
| Hypoaesthesia | 3/98 (3.1%) | 4/96 (4.2%) | 2/98 (2%) | |||
| Somnolence | 24/98 (24.5%) | 22/96 (22.9%) | 20/98 (20.4%) | |||
| Psychiatric disorders | ||||||
| Anxiety | 2/98 (2%) | 4/96 (4.2%) | 6/98 (6.1%) | |||
| Confusional state | 9/98 (9.2%) | 10/96 (10.4%) | 5/98 (5.1%) | |||
| Insomnia | 8/98 (8.2%) | 12/96 (12.5%) | 17/98 (17.3%) | |||
| Renal and urinary disorders | ||||||
| Dysuria | 5/98 (5.1%) | 4/96 (4.2%) | 5/98 (5.1%) | |||
| Skin and subcutaneous tissue disorders | ||||||
| Pruritus | 15/98 (15.3%) | 12/96 (12.5%) | 21/98 (21.4%) | |||
| Vascular disorders | ||||||
| Hypertension | 4/98 (4.1%) | 3/96 (3.1%) | 7/98 (7.1%) | |||
| Hypotension | 12/98 (12.2%) | 11/96 (11.5%) | 5/98 (5.1%) | |||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Pfizer has the right to review disclosures, requesting a delay of < 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), < 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
| Name/Title | Pfizer ClinicalTrials.gov Call Center |
|---|---|
| Organization | Pfizer, Inc. |
| Phone | 1-800-718-1021 |
| ClinicalTrials.govCallCenter@pfizer.com |
Responsible Party:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
ClinicalTrials.gov Identifier:
NCT00442546
Other Study ID Numbers:
- A0081133
First Posted:
Mar 2, 2007
Last Update Posted:
Jan 22, 2021
Last Verified:
Oct 1, 2018