Study Of The Efficacy And Safety Of Pregabalin Compared To Placebo For Treatment Of Post-Surgical Pain From Hysterectomy
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00468845
Collaborator
(none)
501
42
3
40
11.9
0.3
Study Details
Study Description
Brief Summary
To assess the efficacy of pregabalin compared to placebo on pain following hysterectomy , measured using subject reported assessments of pain.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
501 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Multiple Dose, Randomized, Double-Blind Multicenter Study Of The Efficacy And Safety Of Pregabalin Compared To Placebo In The Treatment Of Patients With Post-Surgical Pain From Hysterectomy
Study Start Date
:
Jun 1, 2007
Actual Primary Completion Date
:
May 1, 2010
Actual Study Completion Date
:
Oct 1, 2010
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1
|
Drug: pregabalin (Lyrica)
150 mg/day double blind (divided doses)
|
| Experimental: 2
|
Drug: pregabalin (Lyrica)
300 mg/day double blind (divided doses)
|
| Placebo Comparator: 3
|
Drug: matched placebo
matched placebo
|
Outcome Measures
Primary Outcome Measures
- Worst Pain Using the Modified Brief Pain Inventory - Short Form (m-BPI-sf) [Day 2 (24 hours post surgery [PS])]
Modified Brief Pain Inventory - Short Form (m-BPI-sf): participant rated 11-point Likert rating scale ranged from 0 (no pain) to 10 (worst pain imaginable). Least Square (LS) Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.
Secondary Outcome Measures
- Current Pain - Pain With Movement Caused by Sitting [Day 1 (day of surgery), up to 7 days PS, Discharge, 2 and 4 weeks PS]
Participant sat upright from supine position, followed by 120 second (sec) rest period, during which participant asked to rate pain with movement. Assessment performed 3 times each day of hospital stay, with 1 daily assessment at 24 (+/- 2) hour interval from end of surgery. Current pain reported on 11 point Likert scale 0 (no pain) to 10 (worst pain imaginable). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.
- Current Pain - Pain With Movement Caused by Peak Expiratory (PEF) Test [Day 1, up to 7 days PS, 2 and 4 weeks PS]
Current pain with movement caused by peak expiratory flow (PEF) test as reported by participant on 11 point Likert scale 0 (no pain) to 10 (worst pain). Assessment performed 3 times each day of hospital stay, with 1 daily assessment at 24 (+/- 2) hour interval from end of surgery. PEF test performed 3 times, with 120sec rest periods in between. At beginning of each rest period, participant asked to rate pain caused by forced expiration. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.
- Area Under the Curve (AUC) Pain - Pain With Movement Caused by Sitting [48 +/- 4 hours PS]
Time-normalized AUC of pain with movement caused by sitting reported by participants. Participant sat upright from supine position, followed by a 120sec rest period, during which the participant asked to rate pain with movement. Assessment performed 3 times each day of hospital stay, with 1 daily assessment at 24 (+/- 2) hour interval from end of surgery. Current pain reported on 11 point Likert scale 0 (no pain) to 10 (worst pain imaginable). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.
- Area Under the Curve (AUC) Pain - Pain With Movement Caused by Peak Expiratory Flow (PEF) Test [48 +/- 4 hours PS]
Time-normalized AUC of pain reported by participants with movement caused by PEF test. Pain reported by participant on 11 point Likert scale 0 (no pain) to 10 (worst pain). PEF test performed 3 times, with 120sec rest periods in between. At beginning of each rest period, participant asked to rate pain caused by forced expiration. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.
- Current Pain at Rest [8, 16, 24, 32, 40, 48 hours PS]
Pain reported by participants at rest (numeric rating scale (NRS) - Current Pain) on an 11 point Likert scale 0 (no pain) - 10 (worst pain). Pain at rest during the hospital stay was assessed just before each Pain with Movement assessment. Assessment performed 3 times each day of hospital stay, with 1 of daily assessments at 24 (+/- 2 ) hour intervals from end of surgery. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.
- Area Under the Curve (AUC) of Pain at Rest During the First Two Days of Hospital Stay [48 +/- 4 hours PS]
Time-normalized AUC of pain reported by participants on 11 point Likert scale 0 (no pain) to 10 (worst pain). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.
- Total Cumulative Dose of Opioids Following Surgery [24, 48 Hours PS, Discharge (day 3 up to day 7 PS)]
Total cumulative dose was calculated as milligram (mg) of morphine equivalent and included opioids administered by any route. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.
- Integrated Analgesic Score [0-24, 24-48, 48-72 hours PS]
The integrated analgesic score (a combination of opioid use and either worst pain, or pain at rest, or pain caused by sitting, or pain caused by forced expiration as defined by Silverman et al 1993) was the sum of percent differences from mean rank for pain and opioids and ranged from -200 to 200 where lower values represent improvement. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.
- Non-opioid Rescue Medication - Paracetamol [24, 48, 72 hours PS, Discharge (day 3 up to day 7 PS), Week 1, 2, 3, 4 PS,]
The amounts of non-opioid rescue medications, paracetamol, used by the participants during the study, including anti-emetic medications.
- Anxiety Before and After Surgery [Surgery day before first dose and 1 hour after first dose, Day 1, 2, 3, 4, 5 PS and Discharge (day 3 up to day 7 PS)]
Participant anxiety reported on Visual Anxiety Scale (VAS), 0 (not at all anxious) to 100 (extremely anxious). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata
- Non-opioid Rescue Medication - Ibuprofen [24, 48, 72 hours PS, Discharge (day 3 up to day 7 PS), Week 1, 2, 3, 4 PS]
The amounts of non-opioid rescue medications, ibuprofen, used by the participants during the study, including anti-emetic medications.
- Percent Change From Baseline in Peak Expiratory Flow [Baseline, every 8 hours (up to 232 hours) PS, and Discharge (Day 3-7 PS flexible)]
Change from baseline= PEF at x hours minus PEF at baseline; possible values ranged from 0-900 liters/minute (higher values indicated better lung function). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.
- Timed Up-and-Go (TUG) [Day 1, 2, 3, 4, 5 PS and Discharge (day 3 up to day 7 PS)]
Functional mobility test performed once a day at 24 hour intervals from surgery after the pain with movement assessment. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.
- Average Daily Pain [Day 2, 3, 4, 5, 6, 7, PS; week 2, 3, 4 PS]
Post-discharge average pain as measured in daily participant diaries NRS an 11 point Likert scale ranged from 0 (no pain) to 10 (worst pain). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.
- Worst Daily Pain [Discharge (day 3 up to day 7 PS), Day 7, 14, 28 PS]
Post-discharge worst pain as measured in daily participant diaries NRS an 11 point Likert scale that ranged from 0 (no pain) to 10 (pain as bad as you can imagine). LS Means from ANOVA model with terms of treatment, pooled center, salpingo-oophorectomy strata and baseline worst pain score.
- Sleep Interference [Daily post hospital discharge ( Day 2-7 PS), Week 2, 3, 4 PS]
Sleep interference post surgery measured daily in participant diaries; NRS of how pain interfered with sleep during the last 24 hours, ranged from 0 (does not interfere) to 10 (completely interferes). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.
- Brief Pain Inventory-Short Form (m-BPI-sf): Pain Interference Index Scores [Baseline, Discharge (day 3 up to day 7 PS), Day 7, 14, 28 PS]
m-BPI-sf: participant-rated 11 point Likert rating scale ranging from 0 (does not interfere) to 10 (completely interferes) with functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.
- Brief Pain Inventory-Short Form (m-BPI-sf): Pain Severity Index Scores [Baseline, Discharge (day 3 up to day 7 PS), Day 7, 14, 28 PS]
m-BPI-sf: participant rated 11-point Likert rating scale ranging from 0 (no pain) to 10 (worst pain possible). Pain severity index is the mean of item scores 2, 3, and 4 (pain right now, worst pain, and average pain level). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.
- Participant Satisfaction With Study Medication - Surgery Day [Day 1]
Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1.
- Participant Satisfaction With Study Medication - Day 1 PS [Day 1 PS]
Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1.
- Participant Satisfaction With Study Medication - Day 2 PS [Day 2 PS]
Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1.
- Participant Satisfaction With Study Medication - Day 3 PS [Day 3 PS]
Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1.
- Participant Satisfaction With Study Medication - Day 4 PS [Day 4 PS]
Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1.
- Participant Satisfaction With Study Medication - Day 5 PS [Day 5 PS]
Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1.
- Participant Satisfaction With Study Medication - Discharge [Discharge (day 3 up to day 7 PS)]
Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1.
- Participant Satisfaction With Study Medication - Day 7 PS [Day 7 PS]
Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1.
- Participant Satisfaction With Study Medication - Day 14 PS [Day 14 PS]
Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1.
- Participant Satisfaction With Study Medication - Day 28 PS [Day 28 PS]
Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1.
- Pain Treatment Satisfaction Scale (PTSS): Satisfaction With Current Pain Medication [Discharge (day 3 up to day 7 PS), Day 28 PS]
Satisfaction with current pain medication ranged from 0 (worst possible response) to100 (best possible response). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.
- Pain Treatment Satisfaction Scale (PTSS): Impact of Current Pain Medication [Discharge (day 3 up to day 7 PS), Day 28 PS]
Impact of current pain medication response scale: 0 (worst possible response) to 100 (best possible response). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.
- Quality of Life Using EuroQol (EQ-5D) Health State Profile [Discharge (day 3 up to day 7 PS) and day 28 PS]
Participant rated questionnaire assessed current health for 6 domains: mobility/self-care/ usual activities/pain/discomfort/anxiety and depression. Scoring developed by EuroQol Group assigned a utility value for each domain in the profile. Scores ranged from 1 better health (no problems) to 3 worst health (eg, "confined to bed"). Score transformed and resulted in a total score range -0.594 to 1.000; higher score=better health state. Health profile scores estimated using Dolan computational algorithms 1997 and 2001. LS Means adjusted for treatment/pooled center/salpingo-oophorectomy strata.
- Time to Meet Hospital Discharge Criteria [Day 1 up to Day 7 PS]
Mean time from end of surgery to meet protocol defined hospital discharge criteria: participant no longer received parental opioids, was able to dress and mobilize without assistance, and had normal intake of food and fluids.
- Time to Actual Discharge [Day 1 up to Day 7 PS]
Mean time from end of surgery to actual hospital discharge. Participant was expected to remain at the hospital for a minimum of 2 days following surgery.
- Incidence of Chronic Post-operative Pain [3 and 6 Months PS]
Chronic post-operative pain as a result of abdominal hysterectomy as reported by participants on PS questionaire of pain within last 24 hours in area affected by surgery.
- Total Clinically Meaningful Event (CME) Score [Surgery Day, Day 1, 2, 3, 4, 5 PS, Discharge (day 3 up to day 7 PS), Day 7, 14, 28 PS]
Total CME score calculated by summing the number of Clinically Meaningful Events (CMEs) across symptoms. CME for each symptom will be defined using the Opioid-Related Symptom Distress Scale (OR-SDS) a participant rated scale of symptoms within the last 24 hours. Total CME score could range from 0 to 9. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.
Other Outcome Measures
- Percentage of Participants With Wound Healing Complications - Discharge [Discharge (day 3 up to day 7 PS)]
Pre-specified adverse events of wound healing complications based on Center for Disease Control and Prevention, 1999, guidelines for prevention of surgical site infection (SSI) wound healing complications included: superficial incisional SSI, deep incisional SSI, organ/space SSI or non-infections wound healing complication.
- Percentage of Participants With Wound Healing Complications - Day 7 PS [Day 7 PS]
Pre-specified adverse events of wound healing complications based on Center for Disease Control and Prevention, 1999, guidelines for prevention of surgical site infection (SSI) wound healing complications included: superficial incisional SSI, deep incisional SSI, organ/space SSI or non-infections wound healing complication.
- Percentage of Participants With Wound Healing Complications - Day 14 PS [Day 14 PS]
Pre-specified adverse events of wound healing complications based on Center for Disease Control and Prevention, 1999, guidelines for prevention of surgical site infection (SSI) wound healing complications included: superficial incisional SSI, deep incisional SSI, organ/space SSI or non-infections wound healing complication.
- Percentage of Participants With Wound Healing Complications - Day 28 PS [Day 28 PS]
Pre-specified adverse events of wound healing complications based on Center for Disease Control and Prevention, 1999, guidelines for prevention of surgical site infection (SSI) wound healing complications included: superficial incisional SSI, deep incisional SSI, organ/space SSI or non-infections wound healing complication.
- Percentage of Participants With Wound Healing Complications - End of Treatment [Day 1 up to Day 28 PS]
Pre-specified adverse events of wound healing complications based on Center for Disease Control and Prevention, 1999, guidelines for prevention of surgical site infection (SSI) wound healing complications included: superficial incisional SSI, deep incisional SSI, organ/space SSI or non-infections wound healing complication.
- Incision Length Correlated With Worst Pain [Day 1]
Incision length (cm) correlated with worst pain. Worst pain ranged from 0 (no pain) to 10 (worst pain imaginable). LS Means adjusted for treatment, pooled center, salpingo-oophorectomy strata.
- Neuropathic Pain Symptom Inventory (NPSI) [Discharge (day 3 up to day 7 PS)]
Pain characteristics in participants who reported pain (mBPI-sf, NPSI); NPSI a participant rated questionnaire to evaluate different symptoms of neuropathic pain, burning spontaneous pain, pressing spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dysesthesia at discharge. NPSI Total Score ranged from 0 to 0.5; NPSI subscales pain ranged from 0 (no pain) to 10 (worst pain). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.
Eligibility Criteria
Criteria
Ages Eligible for Study:
25 Years
to 70 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
The subject will have elective total abdominal hysterectomy using a transverse incision with or without bilateral salpingo-oophorectomy. The total hysterectomy may, however, be cervix-sparing.
-
The subject is expected to remain at the hospital (or intermediate care facility) for a minimum of 2 days following surgery.
-
The subject's preoperative health is graded as the American Society of Anesthesiologist P1 to P2.
Exclusion Criteria:
-
Subjects having vaginal hysterectomy (whether laparoscopically assisted or not)
-
Subjects having additional procedures (such as those involving the bladder) at the same time as the total abdominal hysterectomy
-
The use of nerve block, spinal anesthesia or epidural anesthesia for post-surgical pain control
-
Subjects who have been using any opioid medications 2 weeks or more continuously within 3 months prior to the screening visit.
-
The subject has taken any NSAID or any analgesic other than acetaminophen within 3 days prior to surgery or is unwilling to abstain from NSAIDs or other analgesics, except as specified in the protocol, during the study. (Subjects taking <325 mg per day of aspirin at a stable dose for at least 30 days before the first dose of study medication will be allowed to continue their aspirin regimen for the duration of the study).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pfizer Investigational Site | Mobile | Alabama | United States | 36608 |
| 2 | Pfizer Investigational Site | Glendale | Arizona | United States | 85308 |
| 3 | Pfizer Investigational Site | Phoenix | Arizona | United States | 85020 |
| 4 | Pfizer Investigational Site | Phoenix | Arizona | United States | 85023 |
| 5 | Pfizer Investigational Site | Phoenix | Arizona | United States | 85027 |
| 6 | Pfizer Investigational Site | Glendale | California | United States | 91206 |
| 7 | Pfizer Investigational Site | Pasadena | California | United States | 91105 |
| 8 | Pfizer Investigational Site | Miami | Florida | United States | 33136-1096 |
| 9 | Pfizer Investigational Site | Miami | Florida | United States | 33136 |
| 10 | Pfizer Investigational Site | Philadelphia | Pennsylvania | United States | 19104 |
| 11 | Pfizer Investigational Site | Pittsburgh | Pennsylvania | United States | 15213 |
| 12 | Pfizer Investigational Site | Pittsburgh | Pennsylvania | United States | 15232 |
| 13 | Pfizer Investigational Site | Houston | Texas | United States | 77024 |
| 14 | Pfizer Investigational Site | Houston | Texas | United States | 77054 |
| 15 | Pfizer Investigational Site | Calgary | Alberta | Canada | T2N 2T9 |
| 16 | Pfizer Investigational Site | Montreal | Quebec | Canada | H2X 3J4 |
| 17 | Pfizer Investigational Site | Sherbrooke | Quebec | Canada | J1H 5N4 |
| 18 | Pfizer Investigational Site | Praha 5 | Czechia | 150 06 | |
| 19 | Pfizer Investigational Site | Kowloon | Hong Kong | 0 | |
| 20 | Pfizer Investigational Site | Shatin | Hong Kong | ||
| 21 | Pfizer Investigational Site | Johannesburg | Gauteng | South Africa | 1829 |
| 22 | Pfizer Investigational Site | Krugersdorp | Gauteng | South Africa | 1752 |
| 23 | Pfizer Investigational Site | Pretoria | Gauteng | South Africa | 0157 |
| 24 | Pfizer Investigational Site | Newcastle | KwaZulu Natal | South Africa | 2940 |
| 25 | Pfizer Investigational Site | Ladysmith | KZN | South Africa | 3370 |
| 26 | Pfizer Investigational Site | Cape Town | Western Cape | South Africa | 7500 |
| 27 | Pfizer Investigational Site | Parktown | South Africa | 2193 | |
| 28 | Pfizer Investigational Site | Cadiz | Spain | 11009 | |
| 29 | Pfizer Investigational Site | Madrid | Spain | 28031 | |
| 30 | Pfizer Investigational Site | Madrid | Spain | 28046 | |
| 31 | Pfizer Investigational Site | Valencia | Spain | 46010 | |
| 32 | Pfizer Investigational Site | Lund | Sweden | 221 85 | |
| 33 | Pfizer Investigational Site | Orebro | Sweden | 701 85 | |
| 34 | Pfizer Investigational Site | Stockholm | Sweden | 182 88 | |
| 35 | Pfizer Investigational Site | Bangkoknoi | Bangkok | Thailand | 10700 |
| 36 | Pfizer Investigational Site | Muang | Chiang Mai | Thailand | 50200 |
| 37 | Pfizer Investigational Site | Muang | Khon Kaen | Thailand | 40002 |
| 38 | Pfizer Investigational Site | Leicester | Leicestershire | United Kingdom | LE1 5WW |
| 39 | Pfizer Investigational Site | Edinburgh | Scotland | United Kingdom | EH16 4SA |
| 40 | Pfizer Investigational Site | Birmingham | United Kingdom | ||
| 41 | Pfizer Investigational Site | Liverpool | United Kingdom | L8 7SS | |
| 42 | Pfizer Investigational Site | Livingstone | United Kingdom | EH54 6PP |
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:
NCT00468845
Other Study ID Numbers:
- A0081153
First Posted:
May 3, 2007
Last Update Posted:
Feb 10, 2021
Last Verified:
Jun 1, 2011
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 150mg | Pregabalin 300 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | Pregabalin 75 mg twice a day (150 mg/day total) | Pregabalin 150 mg twice a day (300 mg/day total) | Matching placebo capsule |
| Period Title: Overall Study | |||
| STARTED | 162 | 170 | 169 |
| Received Treatment | 161 | 166 | 167 |
| COMPLETED | 141 | 136 | 139 |
| NOT COMPLETED | 21 | 34 | 30 |
Baseline Characteristics
| Arm/Group Title | Pregabalin 150mg | Pregabalin 300 mg | Placebo | Total |
|---|---|---|---|---|
| Arm/Group Description | Pregabalin 75 mg twice a day (150 mg/day total) | Pregabalin 150 mg twice a day (300 mg/day total) | Matching placebo capsule | Total of all reporting groups |
| Overall Participants | 162 | 170 | 169 | 501 |
| Age, Customized (participants) [Number] | ||||
| 25-44 years |
77
47.5%
|
76
44.7%
|
88
52.1%
|
241
48.1%
|
| 45-70 years |
84
51.9%
|
90
52.9%
|
79
46.7%
|
253
50.5%
|
| Unspecified |
1
0.6%
|
4
2.4%
|
2
1.2%
|
7
1.4%
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
162
100%
|
170
100%
|
169
100%
|
501
100%
|
| Male |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Outcome Measures
| Title | Worst Pain Using the Modified Brief Pain Inventory - Short Form (m-BPI-sf) |
|---|---|
| Description | Modified Brief Pain Inventory - Short Form (m-BPI-sf): participant rated 11-point Likert rating scale ranged from 0 (no pain) to 10 (worst pain imaginable). Least Square (LS) Means adjusted for treatment, pooled center and salpingo-oophorectomy strata. |
| Time Frame | Day 2 (24 hours post surgery [PS]) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Modified intent-to-treat (mITT) population: participants who received at least 1 dose study drug, had at least 1 post baseline safety and efficacy evaluation, took all pre-surgery medication, had no complications during surgery with discontinuation, no PS infection with additional hospitalization/readmission, had primary efficacy measurement PS |
| Arm/Group Title | Pregabalin 150mg | Pregabalin 300 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | Pregabalin 75 mg twice a day (150 mg/day total) | Pregabalin 150 mg twice a day (300 mg/day total) | Matching placebo capsule |
| Measure Participants | 151 | 149 | 156 |
| Least Squares Mean (Standard Error) [Units on a scale] |
7.1
(0.18)
|
7.2
(0.18)
|
7.4
(0.18)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1378 |
| Comments | Weighted Z-score test method of Fisher (1998) and Cui et al (1999)applied to maintain alpha level. A step down procedure for multiple comparisons to control the maximum experiment wise type I error rate at 0.05 level. 300mg tested prior to 150mg. | |
| Method | ANOVA | |
| 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 | 0.4710 |
| Comments | Weighted Z-score test method of Fisher (1998) and Cui et al (1999)applied to maintain alpha level. A step down procedure for multiple comparisons to control the maximum experiment wise type I error rate at 0.05 level. 300mg tested prior to 150mg. | |
| Method | ANOVA | |
| Comments | ||
| Title | Current Pain - Pain With Movement Caused by Sitting |
|---|---|
| Description | Participant sat upright from supine position, followed by 120 second (sec) rest period, during which participant asked to rate pain with movement. Assessment performed 3 times each day of hospital stay, with 1 daily assessment at 24 (+/- 2) hour interval from end of surgery. Current pain reported on 11 point Likert scale 0 (no pain) to 10 (worst pain imaginable). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata. |
| Time Frame | Day 1 (day of surgery), up to 7 days PS, Discharge, 2 and 4 weeks PS |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed; Results presented for only those timepoints PS where at least 4 participants in each treatment arm completed the questionnaire at baseline and respective time point. |
| Arm/Group Title | Pregabalin 150mg | Pregabalin 300 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | Pregabalin 75 mg twice a day (150 mg/day total) | Pregabalin 150 mg twice a day (300 mg/day total) | Matching placebo capsule |
| Measure Participants | 147 | 141 | 149 |
| 24 Hours PS (n=147, 141, 149) |
5.21
(0.188)
|
5.53
(0.194)
|
5.28
(0.189)
|
| 48 Hours PS (n=142, 141, 142) |
3.57
(0.185)
|
3.71
(0.189)
|
3.67
(0.189)
|
| 72 Hours PS (n=83, 90, 75) |
2.80
(0.239)
|
3.04
(0.225)
|
3.20
(0.257)
|
| 96 Hours PS (n=29, 31, 26) |
2.31
(0.425)
|
3.20
(0.383)
|
3.20
(0.444)
|
| 120 Hours PS (n=14, 15, 12) |
2.89
(0.584)
|
2.84
(0.527)
|
2.36
(0.633)
|
| 144 Hours PS (n=2, 5, 5) |
1.86
(1.496)
|
1.26
(1.177)
|
2.00
(1.010)
|
| Discharge (n=141, 135, 144) |
2.67
(0.175)
|
2.99
(0.181)
|
2.42
(0.176)
|
| Day 14 (n=126, 120, 128) |
1.08
(0.140)
|
1.37
(0.145)
|
1.30
(0.143)
|
| Day 28 (n=138, 138, 142) |
0.70
(0.126)
|
0.91
(0.129)
|
0.76
(0.127)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | 24 hours PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7752 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | 24 hours PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3375 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | 48 hours PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7029 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | 48 hours PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8618 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | 72 hours PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2117 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | 72 hours PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6255 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | 96 hours PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0942 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | 96 hours PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9907 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | 120 hours PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4678 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | 120 hours PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5500 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | 144 hours PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9333 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | 144 hours PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7396 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 13
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | Discharge | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2932 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 14
| 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 | 0.0164 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 15
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | Day 14 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2468 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 16
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | Day 14 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7022 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 17
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | Day 28 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7257 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 18
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | Day 28 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3854 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
| Title | Current Pain - Pain With Movement Caused by Peak Expiratory (PEF) Test |
|---|---|
| Description | Current pain with movement caused by peak expiratory flow (PEF) test as reported by participant on 11 point Likert scale 0 (no pain) to 10 (worst pain). Assessment performed 3 times each day of hospital stay, with 1 daily assessment at 24 (+/- 2) hour interval from end of surgery. PEF test performed 3 times, with 120sec rest periods in between. At beginning of each rest period, participant asked to rate pain caused by forced expiration. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata. |
| Time Frame | Day 1, up to 7 days PS, 2 and 4 weeks PS |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed; Results presented for only those timepoints PS where at least 4 participants in each treatment arm completed the questionnaire at baseline and respective time point. |
| Arm/Group Title | Pregabalin 150mg | Pregabalin 300 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | Pregabalin 75 mg twice a day (150 mg/day total) | Pregabalin 150 mg twice a day (300 mg/day total) | Matching placebo capsule |
| Measure Participants | 146 | 143 | 148 |
| 24 hours PS (n=146, 142, 148) |
4.83
(0.202)
|
4.92
(0.209)
|
4.97
(0.207)
|
| 48 hours PS (n=141, 143, 140) |
3.22
(0.204)
|
3.47
(0.205)
|
3.46
(0.210)
|
| 72 hours PS (n=83, 90, 74) |
2.62
(0.242)
|
2.69
(0.228)
|
3.04
(0.263)
|
| 96 hours PS (n=28, 31, 25) |
1.88
(0.465)
|
3.05
(0.414)
|
3.28
(0.487)
|
| 120 hours PS (n=13, 14, 11) |
1.97
(0.685)
|
2.10
(0.609)
|
1.45
(0.740)
|
| 144 hours PS (n=2, 5, 3) |
3.67
(2.472)
|
0.67
(1.453)
|
1.67
(1.764)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | 24 hours PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5997 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | 24 hours PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8582 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | 48 hours PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3704 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | 48 hours PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9747 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | 72 hours PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2033 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | 72 hours PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2752 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | 96 hours PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0183 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | 96 hours PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6906 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | 120 hours PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5446 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | 120 hours PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4852 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | 144 hours PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5879 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | 144 hours PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7699 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
| Title | Area Under the Curve (AUC) Pain - Pain With Movement Caused by Sitting |
|---|---|
| Description | Time-normalized AUC of pain with movement caused by sitting reported by participants. Participant sat upright from supine position, followed by a 120sec rest period, during which the participant asked to rate pain with movement. Assessment performed 3 times each day of hospital stay, with 1 daily assessment at 24 (+/- 2) hour interval from end of surgery. Current pain reported on 11 point Likert scale 0 (no pain) to 10 (worst pain imaginable). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata. |
| Time Frame | 48 +/- 4 hours PS |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT; N=number of evaluable participants analyzed |
| Arm/Group Title | Pregabalin 150mg | Pregabalin 300 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | Pregabalin 75 mg twice a day (150 mg/day total) | Pregabalin 150 mg twice a day (300 mg/day total) | Matching placebo capsule |
| Measure Participants | 147 | 140 | 150 |
| Least Squares Mean (Standard Error) [Units on a scale] |
4.87
(0.155)
|
5.01
(0.161)
|
4.87
(0.157)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9676 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
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 | 0.4944 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
| Title | Area Under the Curve (AUC) Pain - Pain With Movement Caused by Peak Expiratory Flow (PEF) Test |
|---|---|
| Description | Time-normalized AUC of pain reported by participants with movement caused by PEF test. Pain reported by participant on 11 point Likert scale 0 (no pain) to 10 (worst pain). PEF test performed 3 times, with 120sec rest periods in between. At beginning of each rest period, participant asked to rate pain caused by forced expiration. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata. |
| Time Frame | 48 +/- 4 hours PS |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT; N=number of evaluable participants analyzed |
| Arm/Group Title | Pregabalin 150mg | Pregabalin 300 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | Pregabalin 75 mg twice a day (150 mg/day total) | Pregabalin 150 mg twice a day (300 mg/day total) | Matching placebo capsule |
| Measure Participants | 148 | 142 | 146 |
| Least Squares Mean (Standard Error) [Units on a scale] |
4.45
(0.167)
|
4.64
(0.174)
|
4.61
(0.173)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4801 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
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 | 0.8832 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
| Title | Current Pain at Rest |
|---|---|
| Description | Pain reported by participants at rest (numeric rating scale (NRS) - Current Pain) on an 11 point Likert scale 0 (no pain) - 10 (worst pain). Pain at rest during the hospital stay was assessed just before each Pain with Movement assessment. Assessment performed 3 times each day of hospital stay, with 1 of daily assessments at 24 (+/- 2 ) hour intervals from end of surgery. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata. |
| Time Frame | 8, 16, 24, 32, 40, 48 hours PS |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed |
| Arm/Group Title | Pregabalin 150mg | Pregabalin 300 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | Pregabalin 75 mg twice a day (150 mg/day total) | Pregabalin 150 mg twice a day (300 mg/day total) | Matching placebo capsule |
| Measure Participants | 151 | 147 | 154 |
| 8 Hours PS (n=123, 125, 126) |
5.13
(0.232)
|
5.39
(0.231)
|
5.47
(0.225)
|
| 16 Hours PS (n=94, 88, 107) |
4.06
(0.256)
|
4.55
(0.273)
|
4.30
(0.245)
|
| 24 Hours PS (n=151, 147, 154) |
3.79
(0.179)
|
3.76
(0.184)
|
3.93
(0.180)
|
| 32 Hours PS (n=127, 127, 136) |
3.37
(0.207)
|
3.31
(0.212)
|
3.55
(0.204)
|
| 40 Hours PS (n=93, 97, 100) |
2.97
(0.265)
|
2.71
(0.265)
|
2.98
(0.263)
|
| 48 Hours PS (n=142, 143, 140) |
2.60
(0.173)
|
2.26
(0.174)
|
2.65
(0.179)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | 8 Hours PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2125 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | 8 Hour PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7602 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | 16 Hours PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4053 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | 16 Hours PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4147 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | 24 Hours PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5556 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | 24 Hours PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4820 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | 32 Hours PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5088 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | 32 Hours PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3900 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | 40 Hours PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9659 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | 40 Hours PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3968 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | 48 Hours PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8308 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | 48 Hours PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0902 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
| Title | Area Under the Curve (AUC) of Pain at Rest During the First Two Days of Hospital Stay |
|---|---|
| Description | Time-normalized AUC of pain reported by participants on 11 point Likert scale 0 (no pain) to 10 (worst pain). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata. |
| Time Frame | 48 +/- 4 hours PS |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT; N=number of evaluable participants analyzed |
| Arm/Group Title | Pregabalin 150mg | Pregabalin 300 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | Pregabalin 75 mg twice a day (150 mg/day total) | Pregabalin 150 mg twice a day (300 mg/day total) | Matching placebo capsule |
| Measure Participants | 151 | 147 | 154 |
| Least Squares Mean (Standard Error) [Units on a scale] |
3.62
(0.143)
|
3.58
(0.147)
|
3.76
(0.144)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4388 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
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 | 0.3364 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
| Title | Total Cumulative Dose of Opioids Following Surgery |
|---|---|
| Description | Total cumulative dose was calculated as milligram (mg) of morphine equivalent and included opioids administered by any route. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata. |
| Time Frame | 24, 48 Hours PS, Discharge (day 3 up to day 7 PS) |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed |
| Arm/Group Title | Pregabalin 150mg | Pregabalin 300 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | Pregabalin 75 mg twice a day (150 mg/day total) | Pregabalin 150 mg twice a day (300 mg/day total) | Matching placebo capsule |
| Measure Participants | 150 | 147 | 153 |
| 24 hours PS (n=150, 147, 153) |
113.38
(7.078)
|
111.27
(7.211)
|
124.44
(7.160)
|
| 48 hours PS (n=150, 147, 151) |
148.67
(9.218)
|
144.95
(9.391)
|
168.31
(9.372)
|
| Till Discharge (n=147, 143, 144) |
164.28
(11.161)
|
167.01
(11.410)
|
195.32
(11.569)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | 24 hours PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2409 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | 24 hours PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1654 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | 48 hours PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1110 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | 48 hours PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0598 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | Till Discharge | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0398 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | Till Discharge | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0623 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
| Title | Integrated Analgesic Score |
|---|---|
| Description | The integrated analgesic score (a combination of opioid use and either worst pain, or pain at rest, or pain caused by sitting, or pain caused by forced expiration as defined by Silverman et al 1993) was the sum of percent differences from mean rank for pain and opioids and ranged from -200 to 200 where lower values represent improvement. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata. |
| Time Frame | 0-24, 24-48, 48-72 hours PS |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed |
| Arm/Group Title | Pregabalin 150mg | Pregabalin 300 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | Pregabalin 75 mg twice a day (150 mg/day total) | Pregabalin 150 mg twice a day (300 mg/day total) | Matching placebo capsule |
| Measure Participants | 150 | 145 | 151 |
| 0-24 Hours PS (n=150, 145, 151) |
-6.58
(6.795)
|
-11.66
(6.991)
|
3.36
(6.906)
|
| 24-48 Hours PS (n=141, 142, 139) |
-5.51
(6.979)
|
-18.84
(7.051)
|
5.48
(7.210)
|
| 48-72 Hours PS (n=81, 89, 74) |
3.23
(9.884)
|
-6.93
(9.271)
|
19.85
(10.568)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | 0-24 Hours PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2730 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | 0-24 Hours PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1015 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | 24-48 Hours PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2438 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | 24-48 Hours PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0102 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | 48-72 Hours PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2063 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | 48-72 Hours PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0387 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
| Title | Non-opioid Rescue Medication - Paracetamol |
|---|---|
| Description | The amounts of non-opioid rescue medications, paracetamol, used by the participants during the study, including anti-emetic medications. |
| Time Frame | 24, 48, 72 hours PS, Discharge (day 3 up to day 7 PS), Week 1, 2, 3, 4 PS, |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed |
| Arm/Group Title | Pregabalin 150mg | Pregabalin 300 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | Pregabalin 75 mg twice a day (150 mg/day total) | Pregabalin 150 mg twice a day (300 mg/day total) | Matching placebo capsule |
| Measure Participants | 150 | 147 | 155 |
| 24 Hours PS (n=150, 147, 155) |
1.16
(0.098)
|
1.21
(0.100)
|
1.22
(0.098)
|
| 48 Hours PS (n=150, 147, 154) |
3.23
(0.195)
|
3.20
(0.199)
|
3.55
(0.195)
|
| 72 Hours PS (n=150, 147,149) |
5.07
(0.294)
|
5.08
(0.300)
|
5.68
(0.301)
|
| 1st Week PS (n=142, 142, 145) |
10.76
(0.732)
|
10.57
(0.739)
|
12.63
(0.740)
|
| 2nd Week PS (n=139, 135, 143) |
17.89
(1.711)
|
16.79
(1.747)
|
19.70
(1.731)
|
| 3rd Week PS (n=131, 124, 134) |
23.56
(2.654)
|
22.12
(2.748)
|
24.35
(2.695)
|
| 4th Week PS (n=95, 94, 103) |
27.10
(3.313)
|
25.62
(3.437)
|
25.63
(3.301)
|
| Till Discharge (n=147, 143, 147) |
5.45
(0.390)
|
5.78
(0.399)
|
6.05
(0.399)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | 24 hours PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5995 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | 24 Hours PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9104 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | 48 Hours PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2177 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | 48 hours PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1770 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | 72 hours PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1229 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | 72 hours PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1274 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | 1st Week PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0568 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | 1st Week PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0354 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | 2nd Week PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4269 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | 2nd Week PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2058 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | 3rd Week PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8215 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | 3rd Week PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5331 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 13
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | 4th Week PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7365 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 14
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | 4th Week PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9989 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 15
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | Till Discharge | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2501 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 16
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | Till Discharge | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6021 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
| Title | Anxiety Before and After Surgery |
|---|---|
| Description | Participant anxiety reported on Visual Anxiety Scale (VAS), 0 (not at all anxious) to 100 (extremely anxious). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata |
| Time Frame | Surgery day before first dose and 1 hour after first dose, Day 1, 2, 3, 4, 5 PS and Discharge (day 3 up to day 7 PS) |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed |
| Arm/Group Title | Pregabalin 150mg | Pregabalin 300 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | Pregabalin 75 mg twice a day (150 mg/day total) | Pregabalin 150 mg twice a day (300 mg/day total) | Matching placebo capsule |
| Measure Participants | 150 | 149 | 154 |
| Surgery Day (prior to first dose)(n=149, 144, 151) |
31.9
(2.38)
|
28.4
(2.45)
|
33.3
(2.40)
|
| Surgery Day (1 hour after dosing)(n=138, 139, 146) |
29.5
(2.39)
|
29.7
(2.39)
|
30.9
(2.38)
|
| Day 1 PS (n=150, 149, 154) |
15.6
(1.75)
|
16.1
(1.78)
|
18.6
(1.77)
|
| Day 2 PS (n=112, 120, 118) |
12.6
(2.05)
|
13.4
(1.98)
|
13.8
(2.03)
|
| Day 3 PS (n=44, 40, 35) |
17.2
(3.17)
|
11.2
(2.93)
|
13.9
(3.20)
|
| Day 4 PS (n=17, 20, 15) |
9.0
(3.22)
|
4.2
(2.72)
|
9.3
(3.51)
|
| Day 5 PS (n=7, 13, 7) |
11.6
(8.31)
|
4.5
(5.39)
|
15.1
(8.46)
|
| Discharge (n=143, 144, 148) |
10.2
(1.50)
|
8.3
(1.50)
|
8.8
(1.50)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | Surgery day (prior to first dose) | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6613 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | Surgery day (prior to first dose) | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1311 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | Surgery day (1 hour after dosing) | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6574 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | Surgery day (1 hour after dosing) | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6949 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | Day 1 PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2008 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | Day 1 PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3022 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | Day 2 PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6382 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | Day 2 PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8624 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | Day 3 PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3858 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | Day 3 PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4814 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | Day 4 PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9520 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | Day 4 PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2315 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 13
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | Day 5 PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7061 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 14
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | Day 5 PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2908 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 15
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | Discharge | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4782 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 16
| 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 | 0.8130 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
| Title | Non-opioid Rescue Medication - Ibuprofen |
|---|---|
| Description | The amounts of non-opioid rescue medications, ibuprofen, used by the participants during the study, including anti-emetic medications. |
| Time Frame | 24, 48, 72 hours PS, Discharge (day 3 up to day 7 PS), Week 1, 2, 3, 4 PS |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed |
| Arm/Group Title | Pregabalin 150mg | Pregabalin 300 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | Pregabalin 75 mg twice a day (150 mg/day total) | Pregabalin 150 mg twice a day (300 mg/day total) | Matching placebo capsule |
| Measure Participants | 150 | 147 | 155 |
| 24 Hours PS (n=150, 147, 155) |
0.01
(0.014)
|
0.03
(0.014)
|
0.01
(0.014)
|
| 48 Hours PS (n=150, 147, 154) |
0.08
(0.037)
|
0.15
(0.038)
|
0.12
(0.038)
|
| 72 Hours PS (n=150, 147, 149) |
0.14
(0.064)
|
0.27
(0.065)
|
0.24
(0.066)
|
| 1st Week PS (n=142, 142, 145) |
0.51
(0.208)
|
0.87
(0.210)
|
0.97
(0.211)
|
| 2nd Week PS (n=140, 135, 143) |
1.22
(0.413)
|
1.94
(0.423)
|
1.88
(0.420)
|
| 3rd Week PS (n=132, 124, 134) |
1.95
(0.665)
|
2.99
(0.692)
|
2.83
(0.679)
|
| 4th Week PS (n=95, 94, 103) |
2.42
(1.041)
|
4.30
(1.080)
|
3.84
(1.038)
|
| Till Discharge (n=147, 143, 147) |
0.18
(0.074)
|
0.38
(0.076)
|
0.26
(0.076)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | 24 hours PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8940 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | 24 hours PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5938 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | 48 hours PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4306 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | 48 hours PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5899 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | 72 hours PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2209 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | 72 hours PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7145 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | 1st Week PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1022 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | 1st Week PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7243 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | 2nd Week PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2310 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | 2nd Week PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9192 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | 3rd Week PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3214 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | 3rd Week PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8641 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 13
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | 4th Week PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3024 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 14
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | 4th Week PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7359 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 15
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | Till Discharge | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4303 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 16
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | Till Discharge | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2133 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
| Title | Percent Change From Baseline in Peak Expiratory Flow |
|---|---|
| Description | Change from baseline= PEF at x hours minus PEF at baseline; possible values ranged from 0-900 liters/minute (higher values indicated better lung function). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata. |
| Time Frame | Baseline, every 8 hours (up to 232 hours) PS, and Discharge (Day 3-7 PS flexible) |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed; Results presented for only those timepoints PS where at least 4 participants in each treatment arm completed the questionnaire at baseline and respective time point. |
| Arm/Group Title | Pregabalin 150mg | Pregabalin 300 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | Pregabalin 75 mg twice a day (150 mg/day total) | Pregabalin 150 mg twice a day (300 mg/day total) | Matching placebo capsule |
| Measure Participants | 116 | 114 | 121 |
| Baseline (n=116, 114, 121) |
0
(0)
|
0
(0)
|
0
(0)
|
| 8 Hours PS (n=84, 79, 83) |
-39.25
(3.081)
|
-35.35
(3.307)
|
-41.29
(3.242)
|
| 16 Hours PS (n=72, 62, 76) |
-37.37
(3.454)
|
-36.49
(3.764)
|
-36.48
(3.395)
|
| 24 Hours PS (n=115, 112, 117) |
-28.92
(3.084)
|
-26.53
(3.212)
|
-29.46
(3.058)
|
| 32 Hours PS (n=104, 105, 106) |
-24.53
(3.510)
|
-25.66
(3.644)
|
-28.92
(3.632)
|
| 40 Hours PS (n=70, 73, 79) |
-24.18
(3.575)
|
-25.70
(3.663)
|
-25.07
(3.449)
|
| 48 Hours PS (n=108, 112, 111) |
-16.71
(3.203)
|
-13.62
(3.255)
|
-21.70
(3.162)
|
| 56 Hours PS (n=78, 85, 82) |
-17.11
(3.760)
|
-15.40
(3.771)
|
-21.12
(3.726)
|
| 64 Hours PS (n=52, 51, 54) |
-15.04
(4.672)
|
-14.20
(5.028)
|
-17.18
(4.392)
|
| 72 Hours PS (n=61, 68, 60) |
-18.12
(5.270)
|
-12.97
(4.792)
|
-20.81
(5.059)
|
| 80 Hours PS (n=30, 24, 24) |
-17.23
(7.290)
|
-3.01
(7.750)
|
-8.17
(7.443)
|
| 88 Hours PS (n=18, 15, 19) |
-10.08
(8.257)
|
-2.30
(8.818)
|
-9.71
(6.636)
|
| 96 Hours PS (n=20, 22, 21) |
-1.45
(9.063)
|
5.26
(8.585)
|
2.36
(9.110)
|
| 104 Hours PS (n=9, 12, 12) |
-12.79
(10.574)
|
0.69
(9.428)
|
-4.94
(10.210)
|
| 112 Hours PS (n=5, 10, 9) |
-15.61
(15.629)
|
8.49
(10.863)
|
-11.61
(10.700)
|
| 120 Hours PS (n=10, 12, 10) |
-12.36
(11.386)
|
-8.14
(10.307)
|
-6.98
(12.201)
|
| 128 Hours PS (n=4, 9, 7) |
-6.72
(13.735)
|
-4.76
(8.166)
|
-14.32
(10.711)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | 8 hours PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5682 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | 8 hours PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1005 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | 16 hours PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8261 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | 16 hours PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9981 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | 24 hours PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8884 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | 24 hours PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4507 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | 32 hours PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2994 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | 32 hours PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4371 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | 40 hours PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8295 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | 40 hours PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8783 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | 48 hours PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2161 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | 48 hours PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0440 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 13
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | 56 hours PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3855 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 14
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | 56 hours PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2010 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 15
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | 64 hours PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7104 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 16
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | 64 hours PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6107 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 17
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | 72 hours PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6705 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 18
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | 72 hours PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2083 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 19
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | 80 hours PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3234 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 20
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | 80 hours PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5938 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 21
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | 88 hours PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9711 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 22
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | 88 hours PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4869 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 23
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | 96 hours PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7439 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 24
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | 96 hours PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8045 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 25
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | 104 hours PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5925 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 26
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | 104 hours PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6830 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 27
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | 112 hours PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8266 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 28
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | 112 hours PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1929 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 29
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | 120 hours PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7071 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 30
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | 120 hours PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9367 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 31
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | 128 hours PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6046 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 32
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | 128 hours PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5119 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
| Title | Timed Up-and-Go (TUG) |
|---|---|
| Description | Functional mobility test performed once a day at 24 hour intervals from surgery after the pain with movement assessment. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata. |
| Time Frame | Day 1, 2, 3, 4, 5 PS and Discharge (day 3 up to day 7 PS) |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed |
| Arm/Group Title | Pregabalin 150mg | Pregabalin 300 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | Pregabalin 75 mg twice a day (150 mg/day total) | Pregabalin 150 mg twice a day (300 mg/day total) | Matching placebo capsule |
| Measure Participants | 130 | 134 | 134 |
| Day 1 PS (n=85, 85, 93) |
39.77
(2.558)
|
42.79
(2.769)
|
38.54
(2.611)
|
| Day 2 PS (n=107, 105, 105) |
31.82
(1.776)
|
33.06
(1.878)
|
29.25
(1.845)
|
| Day 3 PS (n=43, 35, 31) |
34.07
(2.779)
|
33.48
(2.781)
|
31.38
(2.960)
|
| Day 4 PS (n=16, 18, 13) |
42.26
(4.591)
|
37.31
(4.065)
|
40.43
(5.275)
|
| Day 5 PS (n=7, 10, 7) |
31.27
(5.295)
|
23.06
(3.704)
|
32.18
(5.326)
|
| Discharge (n=130, 134, 134) |
28.11
(1.604)
|
30.05
(1.569)
|
26.40
(1.582)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | Day 1 PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6966 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | Day 1 PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1808 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | Day 2 PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2616 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | Day 2 PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1014 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | Day 3 PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4401 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | Day 3 PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5615 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | Day 4 PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7615 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | Day 4 PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6204 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | Day 5 PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8766 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | Day 5 PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1717 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | Discharge | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4065 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
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 | 0.0746 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
| Title | Average Daily Pain |
|---|---|
| Description | Post-discharge average pain as measured in daily participant diaries NRS an 11 point Likert scale ranged from 0 (no pain) to 10 (worst pain). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata. |
| Time Frame | Day 2, 3, 4, 5, 6, 7, PS; week 2, 3, 4 PS |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed |
| Arm/Group Title | Pregabalin 150mg | Pregabalin 300 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | Pregabalin 75 mg twice a day (150 mg/day total) | Pregabalin 150 mg twice a day (300 mg/day total) | Matching placebo capsule |
| Measure Participants | 134 | 131 | 139 |
| Day 2 PS (n=29, 21, 25) |
3.9
(0.48)
|
4.3
(0.55)
|
3.1
(0.59)
|
| Day 3 PS (n=97, 94, 98) |
3.0
(0.22)
|
3.2
(0.23)
|
2.8
(0.23)
|
| Day 4 PS (n=126, 114, 125) |
2.7
(0.19)
|
2.9
(0.21)
|
2.8
(0.20)
|
| Day 5 PS (n=133, 117, 133) |
2.5
(0.18)
|
2.6
(0.20)
|
2.6
(0.19)
|
| Day 6 PS (n=133, 125, 138) |
2.3
(0.18)
|
2.5
(0.19)
|
2.4
(0.18)
|
| Day 7 PS (n=132, 130, 135) |
2.1
(0.17)
|
2.3
(0.17)
|
2.2
(0.17)
|
| 2nd Week PS (Average) (n=134, 131, 139) |
1.7
(0.14)
|
2.0
(0.14)
|
1.7
(0.14)
|
| 3rd Week PS (Average) (n=114, 110, 114) |
1.3
(0.15)
|
1.7
(0.15)
|
1.3
(0.16)
|
| 4th Week PS (Average) (n=87, 87, 82) |
1.2
(0.18)
|
1.6
(0.19)
|
1.2
(0.20)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | Day 2 PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2201 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | Day 2 PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0606 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | Day 3 PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5303 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | Day 3 PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2227 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | Day 4 PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8237 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | Day 4 PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7476 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | Day 5 PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6882 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | Day 5 PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9689 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | Day 6 PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5010 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | Day 6 PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9143 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | Day 7 PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7381 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | Day 7 PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5336 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 13
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | 2nd Week PS (Average) | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6479 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 14
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | 2nd Week PS (Average) | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1133 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 15
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | 3rd Week PS (Average) | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7637 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 16
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | 3rd Week PS (Average) | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1056 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 17
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | 4th Week PS (Average) | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8079 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 18
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | 4th Week PS (Average) | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0917 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
| Title | Worst Daily Pain |
|---|---|
| Description | Post-discharge worst pain as measured in daily participant diaries NRS an 11 point Likert scale that ranged from 0 (no pain) to 10 (pain as bad as you can imagine). LS Means from ANOVA model with terms of treatment, pooled center, salpingo-oophorectomy strata and baseline worst pain score. |
| Time Frame | Discharge (day 3 up to day 7 PS), Day 7, 14, 28 PS |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed |
| Arm/Group Title | Pregabalin 150mg | Pregabalin 300 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | Pregabalin 75 mg twice a day (150 mg/day total) | Pregabalin 150 mg twice a day (300 mg/day total) | Matching placebo capsule |
| Measure Participants | 141 | 143 | 143 |
| Discharge (n=140, 143, 138) |
4.3
(0.22)
|
4.4
(0.22)
|
4.2
(0.22)
|
| Day 7 (n=123, 121, 125) |
3.2
(0.24)
|
3.4
(0.24)
|
3.5
(0.23)
|
| Day 14 (n=129, 125, 130) |
1.8
(0.19)
|
2.4
(0.19)
|
2.5
(0.19)
|
| Day 28 (n=141, 142, 143) |
1.2
(0.15)
|
1.7
(0.15)
|
1.4
(0.15)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | Discharge | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7511 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
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 | 0.6742 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | Day 7 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3808 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | Day 7 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7021 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | Day 14 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0045 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | Day 14 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7916 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | Day 28 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3682 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | Day 28 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1419 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
| Title | Sleep Interference |
|---|---|
| Description | Sleep interference post surgery measured daily in participant diaries; NRS of how pain interfered with sleep during the last 24 hours, ranged from 0 (does not interfere) to 10 (completely interferes). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata. |
| Time Frame | Daily post hospital discharge ( Day 2-7 PS), Week 2, 3, 4 PS |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed |
| Arm/Group Title | Pregabalin 150mg | Pregabalin 300 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | Pregabalin 75 mg twice a day (150 mg/day total) | Pregabalin 150 mg twice a day (300 mg/day total) | Matching placebo capsule |
| Measure Participants | 134 | 131 | 139 |
| Day 2 PS (n=21, 18, 20) |
2.4
(0.65)
|
3.6
(0.67)
|
3.2
(0.77)
|
| Day 3 PS (n=88, 89, 87) |
2.6
(0.32)
|
2.3
(0.33)
|
2.6
(0.33)
|
| Day 4 PS (n=122, 111, 119) |
2.3
(0.24)
|
2.5
(0.27)
|
2.5
(0.26)
|
| Day 5 PS (n=133, 117, 132) |
2.1
(0.22)
|
2.2
(0.24)
|
2.5
(0.22)
|
| Day 6 PS (n=133, 127, 138) |
1.7
(0.22)
|
1.9
(0.23)
|
2.1
(0.22)
|
| Day 7 PS (n=132, 131, 138) |
1.7
(0.22)
|
2.0
(0.22)
|
2.1
(0.22)
|
| 2nd Week PS (Average) (n=134, 131, 139) |
1.3
(0.16)
|
1.7
(0.17)
|
1.5
(0.16)
|
| 3rd Week PS (Average) (n=115, 112, 113) |
1.0
(0.16)
|
1.3
(0.16)
|
1.0
(0.17)
|
| 4th Week PS (Average) (n=87, 87, 81) |
1.0
(0.21)
|
1.4
(0.21)
|
0.9
(0.22)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | Day 2 PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3323 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | Day 2 PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5662 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | Day 3 PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9538 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | Day 3 PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4592 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | Day 4 PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4793 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | Day 4 PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8517 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | Day 5 PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1829 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | Day 5 PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3544 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | Day 6 PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1718 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | Day 6 PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5078 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | Day 7 PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2443 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | Day 7 PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8296 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 13
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | 2nd Week PS (Average) | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3243 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 14
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | 2nd Week PS (Average) | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3755 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 15
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | 3rd Week PS (Average) | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9584 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 16
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | 3rd Week PS (Average) | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1187 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 17
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | 4th Week PS (Average) | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7915 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 18
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | 4th Week PS (Average) | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0703 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
| Title | Brief Pain Inventory-Short Form (m-BPI-sf): Pain Interference Index Scores |
|---|---|
| Description | m-BPI-sf: participant-rated 11 point Likert rating scale ranging from 0 (does not interfere) to 10 (completely interferes) with functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata. |
| Time Frame | Baseline, Discharge (day 3 up to day 7 PS), Day 7, 14, 28 PS |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed |
| Arm/Group Title | Pregabalin 150mg | Pregabalin 300 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | Pregabalin 75 mg twice a day (150 mg/day total) | Pregabalin 150 mg twice a day (300 mg/day total) | Matching placebo capsule |
| Measure Participants | 149 | 147 | 154 |
| Baseline (n=149, 147, 154) |
0
(0)
|
0
(0)
|
0
(0)
|
| Discharge (n=133, 131, 130) |
2.57
(0.194)
|
2.62
(0.198)
|
2.90
(0.200)
|
| Day 7 (n=121, 119, 123) |
1.96
(0.201)
|
2.09
(0.206)
|
2.52
(0.198)
|
| Day 28 (n=140, 141, 142) |
0.85
(0.122)
|
1.01
(0.122)
|
1.07
(0.123)
|
| Day 14 (n=129, 123, 126) |
1.20
(0.148)
|
1.41
(0.152)
|
1.68
(0.152)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | Discharge; | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1975 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
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 | 0.2784 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | Day 7 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0271 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | Day 7 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0881 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | Day 14 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0159 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | Day 14 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1870 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | Day 28 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1752 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | Day 28 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6923 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
| Title | Percentage of Participants With Wound Healing Complications - Discharge |
|---|---|
| Description | Pre-specified adverse events of wound healing complications based on Center for Disease Control and Prevention, 1999, guidelines for prevention of surgical site infection (SSI) wound healing complications included: superficial incisional SSI, deep incisional SSI, organ/space SSI or non-infections wound healing complication. |
| Time Frame | Discharge (day 3 up to day 7 PS) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population all participants who were administered at least one dose of double blind medication, and for whom at least one post-baseline safety evaluation was obtained were included. |
| Arm/Group Title | Pregabalin 150mg | Pregabalin 300 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | Pregabalin 75 mg twice a day (150 mg/day total) | Pregabalin 150 mg twice a day (300 mg/day total) | Matching placebo capsule |
| Measure Participants | 161 | 166 | 167 |
| Superficial Incision SSI |
3.1
1.9%
|
1.2
0.7%
|
0.6
0.4%
|
| Deep Incision SSI |
0
0%
|
0
0%
|
0
0%
|
| Organ/space SSI |
0
0%
|
0
0%
|
0
0%
|
| Non-infectious Wound Healing |
0
0%
|
1.2
0.7%
|
0
0%
|
| Title | Percentage of Participants With Wound Healing Complications - Day 7 PS |
|---|---|
| Description | Pre-specified adverse events of wound healing complications based on Center for Disease Control and Prevention, 1999, guidelines for prevention of surgical site infection (SSI) wound healing complications included: superficial incisional SSI, deep incisional SSI, organ/space SSI or non-infections wound healing complication. |
| Time Frame | Day 7 PS |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population |
| Arm/Group Title | Pregabalin 150mg | Pregabalin 300 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | Pregabalin 75 mg twice a day (150 mg/day total) | Pregabalin 150 mg twice a day (300 mg/day total) | Matching placebo capsule |
| Measure Participants | 161 | 166 | 167 |
| Superficial Incision SSI |
1.9
1.2%
|
2.5
1.5%
|
0.6
0.4%
|
| Deep Incision SSI |
0.6
0.4%
|
0
0%
|
0
0%
|
| Organ/space SSI |
0
0%
|
0
0%
|
0
0%
|
| Non-infectious Wound Healing |
3.8
2.3%
|
1.9
1.1%
|
0.6
0.4%
|
| Title | Brief Pain Inventory-Short Form (m-BPI-sf): Pain Severity Index Scores |
|---|---|
| Description | m-BPI-sf: participant rated 11-point Likert rating scale ranging from 0 (no pain) to 10 (worst pain possible). Pain severity index is the mean of item scores 2, 3, and 4 (pain right now, worst pain, and average pain level). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata. |
| Time Frame | Baseline, Discharge (day 3 up to day 7 PS), Day 7, 14, 28 PS |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed |
| Arm/Group Title | Pregabalin 150mg | Pregabalin 300 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | Pregabalin 75 mg twice a day (150 mg/day total) | Pregabalin 150 mg twice a day (300 mg/day total) | Matching placebo capsule |
| Measure Participants | 149 | 147 | 155 |
| Baseline (n=149, 147, 155) |
0
(0)
|
0
(0)
|
0
(0)
|
| Discharge (n=140, 141, 138) |
2.62
(0.137)
|
2.60
(0.137)
|
2.53
(0.141)
|
| Day 7 (n=122, 121, 125) |
2.05
(0.172)
|
2.16
(0.177)
|
2.20
(0.169)
|
| Day 14 (n=129, 124, 130) |
1.19
(0.137)
|
1.63
(0.142)
|
1.61
(0.138)
|
| Day 28 (n=141, 142, 143) |
0.79
(0.110)
|
0.98
(0.110)
|
0.83
(0.110)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | Discharge | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6295 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
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 | 0.6890 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | Day 7 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5094 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | Day 7 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8741 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | Day 14 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0214 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | Day 14 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9366 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | Day 28 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7833 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | Day 28 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2983 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
| Title | Percentage of Participants With Wound Healing Complications - Day 14 PS |
|---|---|
| Description | Pre-specified adverse events of wound healing complications based on Center for Disease Control and Prevention, 1999, guidelines for prevention of surgical site infection (SSI) wound healing complications included: superficial incisional SSI, deep incisional SSI, organ/space SSI or non-infections wound healing complication. |
| Time Frame | Day 14 PS |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population |
| Arm/Group Title | Pregabalin 150mg | Pregabalin 300 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | Pregabalin 75 mg twice a day (150 mg/day total) | Pregabalin 150 mg twice a day (300 mg/day total) | Matching placebo capsule |
| Measure Participants | 161 | 166 | 167 |
| Superficial Incision SSI |
5.0
3.1%
|
2.5
1.5%
|
2.4
1.4%
|
| Deep Incision SSI |
0.6
0.4%
|
0
0%
|
0
0%
|
| Organ/space SSI |
0.6
0.4%
|
0
0%
|
0
0%
|
| Non-infectious Wound Healing |
4.4
2.7%
|
2.5
1.5%
|
0.6
0.4%
|
| Title | Percentage of Participants With Wound Healing Complications - Day 28 PS |
|---|---|
| Description | Pre-specified adverse events of wound healing complications based on Center for Disease Control and Prevention, 1999, guidelines for prevention of surgical site infection (SSI) wound healing complications included: superficial incisional SSI, deep incisional SSI, organ/space SSI or non-infections wound healing complication. |
| Time Frame | Day 28 PS |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population |
| Arm/Group Title | Pregabalin 150mg | Pregabalin 300 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | Pregabalin 75 mg twice a day (150 mg/day total) | Pregabalin 150 mg twice a day (300 mg/day total) | Matching placebo capsule |
| Measure Participants | 161 | 166 | 167 |
| Superficial Incision SSI |
1.9
1.2%
|
1.9
1.1%
|
1.2
0.7%
|
| Deep Incision SSI |
0
0%
|
0
0%
|
0
0%
|
| Organ/space SSI |
0
0%
|
0
0%
|
0.6
0.4%
|
| Non-infectious Wound Healing |
2.5
1.5%
|
2.5
1.5%
|
0
0%
|
| Title | Participant Satisfaction With Study Medication - Surgery Day |
|---|---|
| Description | Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1. |
| Time Frame | Day 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT; N=number of evaluable participants analyzed |
| Arm/Group Title | Pregabalin 150mg | Pregabalin 300 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | Pregabalin 75 mg twice a day (150 mg/day total) | Pregabalin 150 mg twice a day (300 mg/day total) | Matching placebo capsule |
| Measure Participants | 28 | 32 | 40 |
| Excellent |
14.3
8.8%
|
3.1
1.8%
|
20.0
11.8%
|
| Good |
42.9
26.5%
|
62.5
36.8%
|
35.0
20.7%
|
| Fair |
39.3
24.3%
|
31.3
18.4%
|
30.0
17.8%
|
| Poor |
3.6
2.2%
|
3.1
1.8%
|
15.0
8.9%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | Surgery Day | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6861 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | Cochran-Mantel-Haenszel (CMH) test adjusted for pooled centers and salpingo-oophorectomy strata. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | Surgery Day | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9905 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | CMH test adjusted for pooled centers and salpingo-oophorectomy strata. | |
| Title | Participant Satisfaction With Study Medication - Day 1 PS |
|---|---|
| Description | Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1. |
| Time Frame | Day 1 PS |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT; N=number of evaluable participants analyzed |
| Arm/Group Title | Pregabalin 150mg | Pregabalin 300 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | Pregabalin 75 mg twice a day (150 mg/day total) | Pregabalin 150 mg twice a day (300 mg/day total) | Matching placebo capsule |
| Measure Participants | 150 | 148 | 154 |
| Excellent |
13.3
8.2%
|
17.6
10.4%
|
16.2
9.6%
|
| Good |
56.0
34.6%
|
47.3
27.8%
|
45.5
26.9%
|
| Fair |
26.7
16.5%
|
29.1
17.1%
|
30.5
18%
|
| Poor |
4.0
2.5%
|
6.1
3.6%
|
7.8
4.6%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | Day 1 PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4264 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | CMH test adjusted for pooled centers and salpingo-oophorectomy strata. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | Day 1 PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3045 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | CMH test adjusted for pooled centers and salpingo-oophorectomy strata. | |
| Title | Participant Satisfaction With Study Medication - Day 2 PS |
|---|---|
| Description | Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1. |
| Time Frame | Day 2 PS |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT; N=number of evaluable participants analyzed; |
| Arm/Group Title | Pregabalin 150mg | Pregabalin 300 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | Pregabalin 75 mg twice a day (150 mg/day total) | Pregabalin 150 mg twice a day (300 mg/day total) | Matching placebo capsule |
| Measure Participants | 114 | 119 | 117 |
| Excellent |
21.9
13.5%
|
17.6
10.4%
|
16.2
9.6%
|
| Good |
49.1
30.3%
|
54.6
32.1%
|
47.0
27.8%
|
| Fair |
25.4
15.7%
|
21.8
12.8%
|
29.1
17.2%
|
| Poor |
3.5
2.2%
|
5.9
3.5%
|
7.7
4.6%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | Day 2 PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0714 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | CMH test adjusted for pooled centers and salpingo-oophorectomy strata. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | Day 2 PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4455 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | CMH test adjusted for pooled centers and salpingo-oophorectomy strata. | |
| Title | Participant Satisfaction With Study Medication - Day 3 PS |
|---|---|
| Description | Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1. |
| Time Frame | Day 3 PS |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT; N=number of evaluable participants analyzed |
| Arm/Group Title | Pregabalin 150mg | Pregabalin 300 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | Pregabalin 75 mg twice a day (150 mg/day total) | Pregabalin 150 mg twice a day (300 mg/day total) | Matching placebo capsule |
| Measure Participants | 44 | 40 | 34 |
| Excellent |
15.9
9.8%
|
17.5
10.3%
|
17.6
10.4%
|
| Good |
52.3
32.3%
|
47.5
27.9%
|
50.0
29.6%
|
| Fair |
31.8
19.6%
|
30.0
17.6%
|
29.4
17.4%
|
| Poor |
0
0%
|
5.0
2.9%
|
2.9
1.7%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | Day 3 PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7418 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | CMH test adjusted for pooled centers and salpingo-oophorectomy strata. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | Day 3 PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5154 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | CMH test adjusted for pooled centers and salpingo-oophorectomy strata. | |
| Title | Participant Satisfaction With Study Medication - Day 4 PS |
|---|---|
| Description | Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1. |
| Time Frame | Day 4 PS |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT; N=number of evaluable participants analyzed |
| Arm/Group Title | Pregabalin 150mg | Pregabalin 300 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | Pregabalin 75 mg twice a day (150 mg/day total) | Pregabalin 150 mg twice a day (300 mg/day total) | Matching placebo capsule |
| Measure Participants | 17 | 19 | 14 |
| Excellent |
17.6
10.9%
|
5.3
3.1%
|
14.3
8.5%
|
| Good |
52.9
32.7%
|
57.9
34.1%
|
42.9
25.4%
|
| Fair |
29.4
18.1%
|
31.6
18.6%
|
28.6
16.9%
|
| Poor |
0
0%
|
5.3
3.1%
|
14.3
8.5%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | Day 4 PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6715 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | CMH test adjusted for pooled centers and salpingo-oophorectomy strata. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | Day 4 PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9013 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | CMH test adjusted for pooled centers and salpingo-oophorectomy strata. | |
| Title | Participant Satisfaction With Study Medication - Day 5 PS |
|---|---|
| Description | Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1. |
| Time Frame | Day 5 PS |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT; N=number of evaluable participants analyzed |
| Arm/Group Title | Pregabalin 150mg | Pregabalin 300 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | Pregabalin 75 mg twice a day (150 mg/day total) | Pregabalin 150 mg twice a day (300 mg/day total) | Matching placebo capsule |
| Measure Participants | 7 | 13 | 7 |
| Excellent |
0
0%
|
7.7
4.5%
|
14.3
8.5%
|
| Good |
71.4
44.1%
|
53.8
31.6%
|
42.9
25.4%
|
| Fair |
28.6
17.7%
|
38.5
22.6%
|
28.6
16.9%
|
| Poor |
0
0%
|
0
0%
|
14.3
8.5%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | Day 5 PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9126 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | CMH test adjusted for pooled centers and salpingo-oophorectomy strata. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | Day 5 PS | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 1.0000 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | CMH test adjusted for pooled centers and salpingo-oophorectomy strata. | |
| Title | Participant Satisfaction With Study Medication - Discharge |
|---|---|
| Description | Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1. |
| Time Frame | Discharge (day 3 up to day 7 PS) |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT; N=number of evaluable participants analyzed |
| Arm/Group Title | Pregabalin 150mg | Pregabalin 300 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | Pregabalin 75 mg twice a day (150 mg/day total) | Pregabalin 150 mg twice a day (300 mg/day total) | Matching placebo capsule |
| Measure Participants | 142 | 145 | 148 |
| Excellent |
29.6
18.3%
|
26.2
15.4%
|
26.4
15.6%
|
| Good |
48.6
30%
|
51.0
30%
|
39.9
23.6%
|
| Fair |
16.9
10.4%
|
17.9
10.5%
|
25.0
14.8%
|
| Poor |
4.9
3%
|
4.8
2.8%
|
8.8
5.2%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | Discharge | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1233 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | CMH test adjusted for pooled centers and salpingo-oophorectomy strata. | |
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 | 0.1666 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | CMH test adjusted for pooled centers and salpingo-oophorectomy strata. | |
| Title | Participant Satisfaction With Study Medication - Day 7 PS |
|---|---|
| Description | Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1. |
| Time Frame | Day 7 PS |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT; N=number of evaluable participants analyzed |
| Arm/Group Title | Pregabalin 150mg | Pregabalin 300 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | Pregabalin 75 mg twice a day (150 mg/day total) | Pregabalin 150 mg twice a day (300 mg/day total) | Matching placebo capsule |
| Measure Participants | 123 | 122 | 127 |
| Excellent |
36.6
22.6%
|
36.9
21.7%
|
25.2
14.9%
|
| Good |
38.2
23.6%
|
37.7
22.2%
|
39.4
23.3%
|
| Fair |
15.4
9.5%
|
17.2
10.1%
|
26.0
15.4%
|
| Poor |
9.8
6%
|
8.2
4.8%
|
9.4
5.6%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | Day 7 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0361 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | CMH test adjusted for pooled centers and salpingo-oophorectomy strata. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | Day 7 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0797 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | CMH test adjusted for pooled centers and salpingo-oophorectomy strata. | |
| Title | Participant Satisfaction With Study Medication - Day 14 PS |
|---|---|
| Description | Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1. |
| Time Frame | Day 14 PS |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT; N=number of evaluable participants analyzed |
| Arm/Group Title | Pregabalin 150mg | Pregabalin 300 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | Pregabalin 75 mg twice a day (150 mg/day total) | Pregabalin 150 mg twice a day (300 mg/day total) | Matching placebo capsule |
| Measure Participants | 130 | 126 | 131 |
| Excellent |
40.0
24.7%
|
42.9
25.2%
|
31.3
18.5%
|
| Good |
42.3
26.1%
|
37.3
21.9%
|
33.6
19.9%
|
| Fair |
11.5
7.1%
|
16.7
9.8%
|
24.4
14.4%
|
| Poor |
6.2
3.8%
|
3.2
1.9%
|
10.7
6.3%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | Day 14 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0206 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | CMH test adjusted for pooled centers and salpingo-oophorectomy strata. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | Day 14 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0011 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | CMH test adjusted for pooled centers and salpingo-oophorectomy strata. | |
| Title | Percentage of Participants With Wound Healing Complications - End of Treatment |
|---|---|
| Description | Pre-specified adverse events of wound healing complications based on Center for Disease Control and Prevention, 1999, guidelines for prevention of surgical site infection (SSI) wound healing complications included: superficial incisional SSI, deep incisional SSI, organ/space SSI or non-infections wound healing complication. |
| Time Frame | Day 1 up to Day 28 PS |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population |
| Arm/Group Title | Pregabalin 150mg | Pregabalin 300 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | Pregabalin 75 mg twice a day (150 mg/day total) | Pregabalin 150 mg twice a day (300 mg/day total) | Matching placebo capsule |
| Measure Participants | 161 | 166 | 167 |
| Superficial Incision SSI |
0
0%
|
1.2
0.7%
|
0
0%
|
| Deep Incision SSI |
0
0%
|
0
0%
|
0
0%
|
| Organ/space SSI |
0
0%
|
0
0%
|
0
0%
|
| Non-infectious Wound Healing |
0
0%
|
0
0%
|
0
0%
|
| Title | Incision Length Correlated With Worst Pain |
|---|---|
| Description | Incision length (cm) correlated with worst pain. Worst pain ranged from 0 (no pain) to 10 (worst pain imaginable). LS Means adjusted for treatment, pooled center, salpingo-oophorectomy strata. |
| Time Frame | Day 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT |
| Arm/Group Title | Pregabalin 150mg | Pregabalin 300 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | Pregabalin 75 mg twice a day (150 mg/day total) | Pregabalin 150 mg twice a day (300 mg/day total) | Matching placebo capsule |
| Measure Participants | 151 | 149 | 156 |
| Least Squares Mean (Standard Error) [Centimeter (cm)] |
7.1074
(0.2010)
|
7.2324
(0.1966)
|
7.4437
(0.1977)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | 24 hours | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3506 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
| Title | Participant Satisfaction With Study Medication - Day 28 PS |
|---|---|
| Description | Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1. |
| Time Frame | Day 28 PS |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT; N=number of evaluable participants analyzed |
| Arm/Group Title | Pregabalin 150mg | Pregabalin 300 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | Pregabalin 75 mg twice a day (150 mg/day total) | Pregabalin 150 mg twice a day (300 mg/day total) | Matching placebo capsule |
| Measure Participants | 139 | 142 | 143 |
| Excellent |
42.4
26.2%
|
40.1
23.6%
|
34.3
20.3%
|
| Good |
41.7
25.7%
|
34.5
20.3%
|
35.0
20.7%
|
| Fair |
9.4
5.8%
|
16.2
9.5%
|
23.8
14.1%
|
| Poor |
6.5
4%
|
9.2
5.4%
|
7.0
4.1%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | Day 28 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0287 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | CMH test adjusted for pooled centers and salpingo-oophorectomy strata. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | Day 28 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2270 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | CMH test adjusted for pooled centers and salpingo-oophorectomy strata. | |
| Title | Pain Treatment Satisfaction Scale (PTSS): Satisfaction With Current Pain Medication |
|---|---|
| Description | Satisfaction with current pain medication ranged from 0 (worst possible response) to100 (best possible response). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata. |
| Time Frame | Discharge (day 3 up to day 7 PS), Day 28 PS |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed |
| Arm/Group Title | Pregabalin 150mg | Pregabalin 300 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | Pregabalin 75 mg twice a day (150 mg/day total) | Pregabalin 150 mg twice a day (300 mg/day total) | Matching placebo capsule |
| Measure Participants | 138 | 137 | 139 |
| Medication Subscale/Discharge (n=138, 137, 139) |
79.43
(1.717)
|
78.45
(1.747)
|
76.71
(1.776)
|
| Medication Subscale/Day 28 (n=133, 134, 137) |
82.52
(1.619)
|
80.16
(1.601)
|
78.26
(1.615)
|
| Characteristic Subscale/Discharge (n=138,136,138) |
82.15
(1.565)
|
81.88
(1.597)
|
79.58
(1.623)
|
| Characteristic Subscale/Day 28 (n=133, 133, 137) |
84.82
(1.448)
|
83.16
(1.438)
|
81.69
(1.445)
|
| Efficacy Subscale/Discharge (n=138, 137, 139) |
76.68
(2.264)
|
75.04
(2.304)
|
73.77
(2.342)
|
| Efficacy Subscale/Day 28 (n=133, 134, 136) |
80.20
(2.161)
|
76.92
(2.138)
|
74.82
(2.166)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | Medication Subscale at Discharge | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1872 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | Medication Subscale at Discharge | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3994 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | Medication Subscale at Day 28 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0422 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | Medication Subscale at Day 28 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3647 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | Characteristics at Discharge | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1729 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | Characteristics at Discharge | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2234 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | Characteristics at Day 28 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0950 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | Characteristics at Day 28 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4345 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | Efficacy at Discharge | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2840 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | Efficacy at Discharge | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6404 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | Efficacy at Day 28 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0550 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | Efficacy at Day 28 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4531 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
| Title | Pain Treatment Satisfaction Scale (PTSS): Impact of Current Pain Medication |
|---|---|
| Description | Impact of current pain medication response scale: 0 (worst possible response) to 100 (best possible response). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata. |
| Time Frame | Discharge (day 3 up to day 7 PS), Day 28 PS |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed |
| Arm/Group Title | Pregabalin 150mg | Pregabalin 300 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | Pregabalin 75 mg twice a day (150 mg/day total) | Pregabalin 150 mg twice a day (300 mg/day total) | Matching placebo capsule |
| Measure Participants | 139 | 141 | 141 |
| Discharge (n=139, 141, 140) |
72.73
(2.080)
|
66.28
(2.099)
|
72.82
(2.159)
|
| Day 28 (n=133, 135, 141) |
76.41
(2.180)
|
69.53
(2.181)
|
69.05
(2.156)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | Discharge | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9712 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
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 | 0.0112 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | Day 28 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0090 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | Day 28 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8650 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
| Title | Quality of Life Using EuroQol (EQ-5D) Health State Profile |
|---|---|
| Description | Participant rated questionnaire assessed current health for 6 domains: mobility/self-care/ usual activities/pain/discomfort/anxiety and depression. Scoring developed by EuroQol Group assigned a utility value for each domain in the profile. Scores ranged from 1 better health (no problems) to 3 worst health (eg, "confined to bed"). Score transformed and resulted in a total score range -0.594 to 1.000; higher score=better health state. Health profile scores estimated using Dolan computational algorithms 1997 and 2001. LS Means adjusted for treatment/pooled center/salpingo-oophorectomy strata. |
| Time Frame | Discharge (day 3 up to day 7 PS) and day 28 PS |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed |
| Arm/Group Title | Pregabalin 150mg | Pregabalin 300 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | Pregabalin 75 mg twice a day (150 mg/day total) | Pregabalin 150 mg twice a day (300 mg/day total) | Matching placebo capsule |
| Measure Participants | 140 | 143 | 142 |
| EQ-5D 1997, Discharge (n=138, 141, 138) |
0.57
(0.021)
|
0.61
(0.021)
|
0.58
(0.022)
|
| EQ-5D 1997, Day 28 (n=140, 143, 142) |
0.81
(0.014)
|
0.78
(0.014)
|
0.78
(0.014)
|
| EQ-5D 2001, Discharge (n=138, 141, 138) |
0.59
(0.018)
|
0.62
(0.018)
|
0.60
(0.019)
|
| EQ-5D 2001, Day 28 (n=140, 143, 142) |
0.81
(0.014)
|
0.78
(0.014)
|
0.78
(0.014)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | EQ-5D 1997 Discharge | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8914 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | EQ-5D 1997 Discharge | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2214 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | EQ-5D 1997 Day 28 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1008 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | EQ-5D 1997 Day 28 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9135 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | EQ-5D 2001 Discharge | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5609 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | EQ-5D 2001 Discharge | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4047 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | EQ-5D 2001 Day 28 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1663 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | EQ-5D 2001 Day 28 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8364 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
| Title | Time to Meet Hospital Discharge Criteria |
|---|---|
| Description | Mean time from end of surgery to meet protocol defined hospital discharge criteria: participant no longer received parental opioids, was able to dress and mobilize without assistance, and had normal intake of food and fluids. |
| Time Frame | Day 1 up to Day 7 PS |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT |
| Arm/Group Title | Pregabalin 150mg | Pregabalin 300 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | Pregabalin 75 mg twice a day (150 mg/day total) | Pregabalin 150 mg twice a day (300 mg/day total) | Matching placebo capsule |
| Measure Participants | 151 | 149 | 156 |
| Mean (Standard Error) [Hours] |
57.670
(2.829)
|
60.751
(2.678)
|
58.745
(2.786)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | Kaplan-Meier method was used for survival distribution estimation; | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7218 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | Kaplan-Meier method was used for survival distribution estimation; | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4425 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Title | Time to Actual Discharge |
|---|---|
| Description | Mean time from end of surgery to actual hospital discharge. Participant was expected to remain at the hospital for a minimum of 2 days following surgery. |
| Time Frame | Day 1 up to Day 7 PS |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT |
| Arm/Group Title | Pregabalin 150mg | Pregabalin 300 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | Pregabalin 75 mg twice a day (150 mg/day total) | Pregabalin 150 mg twice a day (300 mg/day total) | Matching placebo capsule |
| Measure Participants | 151 | 149 | 156 |
| Mean (Standard Error) [Hours] |
79.339
(2.547)
|
85.221
(3.935)
|
78.740
(2.441)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | Kaplan-Meier method was used for survival distribution estimation; | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7889 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | Kaplan-Meier method was used for survival distribution estimation; | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1565 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Title | Neuropathic Pain Symptom Inventory (NPSI) |
|---|---|
| Description | Pain characteristics in participants who reported pain (mBPI-sf, NPSI); NPSI a participant rated questionnaire to evaluate different symptoms of neuropathic pain, burning spontaneous pain, pressing spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dysesthesia at discharge. NPSI Total Score ranged from 0 to 0.5; NPSI subscales pain ranged from 0 (no pain) to 10 (worst pain). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata. |
| Time Frame | Discharge (day 3 up to day 7 PS) |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed |
| Arm/Group Title | Pregabalin 150mg | Pregabalin 300 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | Pregabalin 75 mg twice a day (150 mg/day total) | Pregabalin 150 mg twice a day (300 mg/day total) | Matching placebo capsule |
| Measure Participants | 139 | 145 | 143 |
| Total subscale(n=132, 131, 136) |
0.073
(0.0057)
|
0.070
(0.0057)
|
0.076
(0.0058)
|
| Burning Spontaneous subscale (n=139, 145, 143) |
1.86
(0.235)
|
1.80
(0.231)
|
1.75
(0.235)
|
| Pressing Spontaneous subscale (n=139, 145, 143) |
1.74
(0.166)
|
1.60
(0.164)
|
1.57
(0.168)
|
| Paroxysmal pain subscale (n=138, 140, 143) |
1.08
(0.155)
|
0.95
(0.154)
|
1.18
(0.156)
|
| Evoked Pain subscale (n=134, 135, 142) |
2.14
(0.177)
|
2.27
(0.177)
|
2.27
(0.175)
|
| Paresthesia/dysesthesia (n=136, 140, 141) |
0.46
(0.129)
|
0.67
(0.127)
|
0.91
(0.128)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | Total subscale | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6211 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | Total subscale | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3687 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | Burning Spontaneous subscale | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7078 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | Burning Spontaneous subscale | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8696 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | Pressing Spontaneous subscale | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4320 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | Pressing Spontaneous subscale | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8843 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | Paroxysmal pain subscale | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6215 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | Paroxysmal pain subscale | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2722 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | Evoked Pain subscale | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5500 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | Evoked Pain subscale | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9942 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | Paresthesia/dysesthesia | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0075 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | Paresthesia/dysesthesia | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1464 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
| Title | Incidence of Chronic Post-operative Pain |
|---|---|
| Description | Chronic post-operative pain as a result of abdominal hysterectomy as reported by participants on PS questionaire of pain within last 24 hours in area affected by surgery. |
| Time Frame | 3 and 6 Months PS |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed. Participants reported as no chronic pain in the 3 month visit were carried over to the missing data at 6 month visit. |
| Arm/Group Title | Pregabalin 150mg | Pregabalin 300 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | Pregabalin 75 mg twice a day (150 mg/day total) | Pregabalin 150 mg twice a day (300 mg/day total) | Matching placebo capsule |
| Measure Participants | 138 | 127 | 141 |
| Months 3 PS (n =136, 127, 138) |
12.5
7.7%
|
17.3
10.2%
|
10.1
6%
|
| Months 6 PS (n =138, 127, 141) |
6.5
4%
|
6.3
3.7%
|
4.3
2.5%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | Incidence of chronic PS pain at Month 3 PS. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9877 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | p-values are derived from CMH test adjusted for pooled centers and salpingo-oophorectomy strata | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | Incidence of chronic PS pain at Month 3 PS. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1334 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | p-values are derived from CMH test adjusted for pooled centers and salpingo-oophorectomy strata | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | Incidence of chronic PS pain at Month 6 PS. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3566 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | p-values are derived from CMH test adjusted for pooled centers and salpingo-oophorectomy strata | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | Incidence of chronic PS pain at Month 6 PS. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6262 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | p-values are derived from CMH test adjusted for pooled centers and salpingo-oophorectomy strata | |
| Title | Total Clinically Meaningful Event (CME) Score |
|---|---|
| Description | Total CME score calculated by summing the number of Clinically Meaningful Events (CMEs) across symptoms. CME for each symptom will be defined using the Opioid-Related Symptom Distress Scale (OR-SDS) a participant rated scale of symptoms within the last 24 hours. Total CME score could range from 0 to 9. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata. |
| Time Frame | Surgery Day, Day 1, 2, 3, 4, 5 PS, Discharge (day 3 up to day 7 PS), Day 7, 14, 28 PS |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed |
| Arm/Group Title | Pregabalin 150mg | Pregabalin 300 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | Pregabalin 75 mg twice a day (150 mg/day total) | Pregabalin 150 mg twice a day (300 mg/day total) | Matching placebo capsule |
| Measure Participants | 148 | 147 | 154 |
| Surgery Day (n=26, 25, 32) |
0.9
(0.29)
|
0.8
(0.30)
|
0.9
(0.26)
|
| Day 1 PS (n=148, 147, 154) |
1.1
(0.13)
|
1.1
(0.13)
|
1.2
(0.13)
|
| Day 2 PS (n=108, 116, 114) |
0.6
(0.12)
|
0.6
(0.12)
|
0.7
(0.12)
|
| Day 3 PS (n=38, 36, 32) |
0.5
(0.19)
|
0.7
(0.17)
|
0.3
(0.19)
|
| Day 4 PS (n=14, 16, 11) |
0.0
(0.19)
|
0.4
(0.15)
|
0.3
(0.22)
|
| Day 5 PS (n=5, 9, 6) |
0.4
(0.19)
|
0.1
(0.13)
|
0.3
(0.18)
|
| Discharge (n=133, 132, 133) |
0.4
(0.09)
|
0.4
(0.09)
|
0.3
(0.09)
|
| Day 7 PS (n=119, 117, 120) |
0.2
(0.06)
|
0.4
(0.06)
|
0.2
(0.06)
|
| Day 14 PS (n=119, 116, 124) |
0.1
(0.06)
|
0.2
(0.06)
|
0.1
(0.06)
|
| Day 28 PS (n=129, 135, 136) |
0.0
(0.06)
|
0.2
(0.06)
|
0.2
(0.06)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | Surgery day; | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9463 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | Surgery day; | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7347 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | Day 1 PS; | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4132 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | Day 1 PS; | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4929 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | Day 2 PS; | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6003 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | Day 2 PS; | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9343 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | Day 3 PS; | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3838 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | Day 3 PS; | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1351 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | Day 4 PS; | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3343 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | Day 4 PS; | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7948 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | Day 5 PS; | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8090 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | Day 5 PS; | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4035 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 13
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | Discharge | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6009 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 14
| 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 | 0.7597 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 15
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | Day 7 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7804 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 16
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | Day 7 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0463 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 17
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | Day 14 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4951 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 18
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | Day 14 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3030 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 19
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 150mg, Placebo |
|---|---|---|
| Comments | Day 28 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0104 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Statistical Analysis 20
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin 300 mg, Placebo |
|---|---|---|
| Comments | Day 28 | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6978 |
| Comments | ||
| Method | ANOVA | |
| Comments | LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata. | |
Adverse Events
| Time Frame | ||||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||
| Arm/Group Title | Pregabalin 150mg | Pregabalin 300 mg | Placebo | |||
| Arm/Group Description | Pregabalin 75 mg twice a day (150 mg/day total) | Pregabalin 150 mg twice a day (300 mg/day total) | Matching placebo capsule | |||
All Cause Mortality |
||||||
| Pregabalin 150mg | Pregabalin 300 mg | Placebo | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
| Pregabalin 150mg | Pregabalin 300 mg | Placebo | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 9/161 (5.6%) | 11/166 (6.6%) | 15/167 (9%) | |||
| Blood and lymphatic system disorders | ||||||
| Anaemia | 0/161 (0%) | 1/166 (0.6%) | 0/167 (0%) | |||
| Cardiac disorders | ||||||
| Atrioventricular block complete | 0/161 (0%) | 0/166 (0%) | 1/167 (0.6%) | |||
| Tachycardia | 0/161 (0%) | 1/166 (0.6%) | 0/167 (0%) | |||
| Gastrointestinal disorders | ||||||
| Abdominal distension | 0/161 (0%) | 0/166 (0%) | 1/167 (0.6%) | |||
| Abdominal pain | 1/161 (0.6%) | 0/166 (0%) | 1/167 (0.6%) | |||
| Abdominal pain lower | 0/161 (0%) | 1/166 (0.6%) | 0/167 (0%) | |||
| Constipation | 0/161 (0%) | 0/166 (0%) | 1/167 (0.6%) | |||
| Gastritis | 1/161 (0.6%) | 0/166 (0%) | 0/167 (0%) | |||
| Ileus | 1/161 (0.6%) | 0/166 (0%) | 0/167 (0%) | |||
| Intestinal obstruction | 0/161 (0%) | 0/166 (0%) | 1/167 (0.6%) | |||
| Rectal perforation | 0/161 (0%) | 0/166 (0%) | 1/167 (0.6%) | |||
| Umbilical hernia | 1/161 (0.6%) | 0/166 (0%) | 0/167 (0%) | |||
| General disorders | ||||||
| Chest pain | 0/161 (0%) | 0/166 (0%) | 1/167 (0.6%) | |||
| Impaired healing | 0/161 (0%) | 1/166 (0.6%) | 0/167 (0%) | |||
| Pyrexia | 1/161 (0.6%) | 1/166 (0.6%) | 1/167 (0.6%) | |||
| Infections and infestations | ||||||
| Incision site infection | 0/161 (0%) | 0/166 (0%) | 1/167 (0.6%) | |||
| Pneumonia | 0/161 (0%) | 0/166 (0%) | 1/167 (0.6%) | |||
| Postoperative wound infection | 2/161 (1.2%) | 1/166 (0.6%) | 1/167 (0.6%) | |||
| Pyelonephritis | 0/161 (0%) | 0/166 (0%) | 1/167 (0.6%) | |||
| Sepsis | 0/161 (0%) | 1/166 (0.6%) | 0/167 (0%) | |||
| Urinary tract infection | 0/161 (0%) | 1/166 (0.6%) | 1/167 (0.6%) | |||
| Wound infection | 0/161 (0%) | 1/166 (0.6%) | 1/167 (0.6%) | |||
| Injury, poisoning and procedural complications | ||||||
| Abdominal wound dehiscence | 0/161 (0%) | 0/166 (0%) | 1/167 (0.6%) | |||
| Post procedural haematoma | 1/161 (0.6%) | 1/166 (0.6%) | 0/167 (0%) | |||
| Postoperative ileus | 1/161 (0.6%) | 0/166 (0%) | 0/167 (0%) | |||
| Ureteric injury | 0/161 (0%) | 0/166 (0%) | 1/167 (0.6%) | |||
| Wound complication | 0/161 (0%) | 0/166 (0%) | 1/167 (0.6%) | |||
| Investigations | ||||||
| Liver function test abnormal | 1/161 (0.6%) | 0/166 (0%) | 0/167 (0%) | |||
| Oxygen saturation decreased | 1/161 (0.6%) | 0/166 (0%) | 0/167 (0%) | |||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
| Cervix carcinoma | 0/161 (0%) | 1/166 (0.6%) | 0/167 (0%) | |||
| Endometrial cancer | 0/161 (0%) | 1/166 (0.6%) | 0/167 (0%) | |||
| Renal and urinary disorders | ||||||
| Dysuria | 0/161 (0%) | 0/166 (0%) | 1/167 (0.6%) | |||
| Ureteric stenosis | 0/161 (0%) | 1/166 (0.6%) | 0/167 (0%) | |||
| Reproductive system and breast disorders | ||||||
| Pelvic haematoma | 0/161 (0%) | 0/166 (0%) | 1/167 (0.6%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| Dyspnoea | 0/161 (0%) | 1/166 (0.6%) | 0/167 (0%) | |||
| Hypoxia | 0/161 (0%) | 0/166 (0%) | 1/167 (0.6%) | |||
| Vascular disorders | ||||||
| Haematoma | 0/161 (0%) | 1/166 (0.6%) | 0/167 (0%) | |||
| Hypertension | 0/161 (0%) | 1/166 (0.6%) | 0/167 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| Pregabalin 150mg | Pregabalin 300 mg | Placebo | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 125/161 (77.6%) | 128/166 (77.1%) | 124/167 (74.3%) | |||
| Blood and lymphatic system disorders | ||||||
| Anaemia | 9/161 (5.6%) | 5/166 (3%) | 5/167 (3%) | |||
| Cardiac disorders | ||||||
| Tachycardia | 4/161 (2.5%) | 6/166 (3.6%) | 3/167 (1.8%) | |||
| Eye disorders | ||||||
| Vision blurred | 2/161 (1.2%) | 4/166 (2.4%) | 0/167 (0%) | |||
| Gastrointestinal disorders | ||||||
| Abdominal distension | 6/161 (3.7%) | 5/166 (3%) | 3/167 (1.8%) | |||
| Abdominal pain | 6/161 (3.7%) | 4/166 (2.4%) | 10/167 (6%) | |||
| Constipation | 46/161 (28.6%) | 49/166 (29.5%) | 45/167 (26.9%) | |||
| Diarrhoea | 4/161 (2.5%) | 2/166 (1.2%) | 7/167 (4.2%) | |||
| Dyspepsia | 5/161 (3.1%) | 6/166 (3.6%) | 6/167 (3.6%) | |||
| Flatulence | 16/161 (9.9%) | 10/166 (6%) | 13/167 (7.8%) | |||
| Nausea | 67/161 (41.6%) | 60/166 (36.1%) | 76/167 (45.5%) | |||
| Retching | 0/161 (0%) | 6/166 (3.6%) | 4/167 (2.4%) | |||
| Vomiting | 33/161 (20.5%) | 20/166 (12%) | 30/167 (18%) | |||
| General disorders | ||||||
| Chills | 1/161 (0.6%) | 2/166 (1.2%) | 4/167 (2.4%) | |||
| Fatigue | 38/161 (23.6%) | 46/166 (27.7%) | 34/167 (20.4%) | |||
| Oedema peripheral | 4/161 (2.5%) | 1/166 (0.6%) | 1/167 (0.6%) | |||
| Pain | 4/161 (2.5%) | 3/166 (1.8%) | 3/167 (1.8%) | |||
| Pyrexia | 31/161 (19.3%) | 29/166 (17.5%) | 24/167 (14.4%) | |||
| Infections and infestations | ||||||
| Urinary tract infection | 13/161 (8.1%) | 12/166 (7.2%) | 8/167 (4.8%) | |||
| Wound infection | 5/161 (3.1%) | 5/166 (3%) | 3/167 (1.8%) | |||
| Injury, poisoning and procedural complications | ||||||
| Procedural pain | 2/161 (1.2%) | 4/166 (2.4%) | 2/167 (1.2%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| Back pain | 6/161 (3.7%) | 4/166 (2.4%) | 4/167 (2.4%) | |||
| Nervous system disorders | ||||||
| Disturbance in attention | 24/161 (14.9%) | 30/166 (18.1%) | 23/167 (13.8%) | |||
| Dizziness | 51/161 (31.7%) | 52/166 (31.3%) | 37/167 (22.2%) | |||
| Headache | 27/161 (16.8%) | 23/166 (13.9%) | 19/167 (11.4%) | |||
| Hypoaesthesia | 0/161 (0%) | 4/166 (2.4%) | 4/167 (2.4%) | |||
| Migraine | 2/161 (1.2%) | 4/166 (2.4%) | 2/167 (1.2%) | |||
| Paraesthesia | 4/161 (2.5%) | 0/166 (0%) | 2/167 (1.2%) | |||
| Somnolence | 39/161 (24.2%) | 39/166 (23.5%) | 36/167 (21.6%) | |||
| Psychiatric disorders | ||||||
| Confusional state | 12/161 (7.5%) | 12/166 (7.2%) | 9/167 (5.4%) | |||
| Insomnia | 9/161 (5.6%) | 9/166 (5.4%) | 10/167 (6%) | |||
| Renal and urinary disorders | ||||||
| Dysuria | 14/161 (8.7%) | 22/166 (13.3%) | 16/167 (9.6%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| Cough | 4/161 (2.5%) | 3/166 (1.8%) | 2/167 (1.2%) | |||
| Skin and subcutaneous tissue disorders | ||||||
| Pruritus | 27/161 (16.8%) | 22/166 (13.3%) | 26/167 (15.6%) | |||
| Rash | 0/161 (0%) | 4/166 (2.4%) | 0/167 (0%) | |||
| Vascular disorders | ||||||
| Haematoma | 6/161 (3.7%) | 6/166 (3.6%) | 2/167 (1.2%) | |||
| Hypertension | 3/161 (1.9%) | 4/166 (2.4%) | 2/167 (1.2%) | |||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Results Point of Contact
| Name/Title | Pfizer ClinicalTrials.gov Call Center |
|---|---|
| Organization | Pfizer, Inc. |
| Phone | 1-800-718-1021 |
| ClinicalTrials.gov_Inquiries@pfizer.com |
Responsible Party:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
ClinicalTrials.gov Identifier:
NCT00468845
Other Study ID Numbers:
- A0081153
First Posted:
May 3, 2007
Last Update Posted:
Feb 10, 2021
Last Verified:
Jun 1, 2011