Study To Evaluate Efficacy, Safety And Tolerability Of Lyrica In Patients With Painful Diabetic Peripheral Neuropathy
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01332149
Collaborator
(none)
626
30
2
35
20.9
0.6
Study Details
Study Description
Brief Summary
Pregabalin has proven effective in previous clinical trails in other countries in relieving neuropathic pain associated with postherpetic neuralgia and painful diabetic neuropathy.
This study is being conducted according to China registration requirement to submit a reapplication with new local diabetic peripheral neuropathy study as a commitment plus the existing data to apply for Lyrica "pain associated with postherpetic neuralgia" indication after Lyrica "pain associated with postherpetic neuralgia" is approved.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
626 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
An 11-week Randomized, Double-blind, Multi Center, Placebo-controlled Study To Evaluate The Efficacy, Safety And Tolerability Of Pregabalin (300 Mg/Day) Using A Fixed Dosing Schedule In The Treatment Of Subjects S With Pain Associated With Diabetic Peripheral Neuropathy.
Study Start Date
:
Jul 1, 2011
Actual Primary Completion Date
:
Apr 1, 2014
Actual Study Completion Date
:
Jun 1, 2014
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 300 mg/day pregabalin (Lyrica) Patient take pregabalin capsule twice a day |
Drug: Pregabalin
Subjects in the pregabalin group will start treatment with pregabalin capsule 150 mg/day for 1 week, then their dose will be increased to 300mg/day. After 1-week titration period, dose must be stable during study, no dose adjustment is permitted, and subject who cannot tolerate 300 mg/day pregabalin will be withdrawn.
At the completion of the dose maintenance phase subjects will taper off study medication over a 1-week period. 300 mg/ day subjects will taper to 150 mg/ day.
|
| Placebo Comparator: Placebo
|
Drug: Placebo matched with pregabalin
Subject will take placebo matched with pregabalin twice a day.
|
Outcome Measures
Primary Outcome Measures
- Baseline Mean Pain Score [Baseline]
The daily pain rating scale (DPRS) consists of an 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10.
- Change From Baseline in Mean Pain Score at Endpoint [Baseline and end of fixed dose phase (Day 63/Week 9)/Early Termination (Study Endpoint)]
The daily pain rating scale (DPRS) consists of an 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10. The mean endpoint pain score was obtained from the last 7 available DPRS scores of the daily pain diary while the participant was on study medication, up to and including the day after the last Week 8 (Day 57) dose.
Secondary Outcome Measures
- Change From Baseline in Weekly Mean Pain Score at Weeks 1 to 9 [Baseline and weekly from Weeks 1 to 9]
The DPRS consists of an 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10. The weekly mean pain score was the sum of the daily scores divided by the number of diary entries during that week. The overall change is the average change from Weeks 1 to 9.
- Baseline Mean Sleep Interference Score [Baseline]
Pain-related sleep interference was assessed on an 11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]). Participants were to describe how their pain had interfered with their sleep during the past 24 hours by choosing the appropriate number between 0 and 10.
- Change From Baseline in Mean Sleep Interference Score at Endpoint [Baseline and end of fixed dose phase (Day 63/Week 9)/Early Termination (Study Endpoint)]
Pain-related sleep interference was assessed on an 11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]). Participants were to describe how their pain had interfered with their sleep during the past 24 hours by choosing the appropriate number between 0 and 10. The mean endpoint score was obtained from the last 7 available scores of the daily diary while the participant was on study medication, up to and including the day after the last Week 9 (Day 63) dose.
- Change From Baseline in Weekly Mean Sleep Interference Score at Weeks 1 to 9 [Baseline and weekly from Weeks 1 to 9]
Pain-related sleep interference was assessed on an 11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]). Participants were to describe how their pain had interfered with their sleep during the past 24 hours by choosing the appropriate number between 0 and 10. The weekly mean score was the sum of the daily scores divided by the number of diary entries during that week. The overall change is the average change from Weeks 1 to 9.
- Percentage of 30 Percent (%) Responders at Endpoint [End of fixed dose phase (Day 63/Week 9)/Early Termination (Study Endpoint)]
The DPRS consists of an 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10. A 30% responder was a participant who had 30% reduction or more in mean pain score at the end of the fixed dose phase (Day 63/Week 9) (Study Endpoint) compared to baseline.
- Change From Baseline in Short Form McGill Pain Questionnaire (SF-MPQ) Score at Weeks 1, 5, and 9 [Baseline; Weeks 1, 5, and 9]
SF-MPQ was assessed according to the participant's answer to the SF-MPQ questionnaire. The score for each composite scale (sensory, affective, and total) was derived by summing the reported intensity value for each item within a particular scale where None=0, Mild=1, Moderate=2, and Severe=3. The sensory score was the sum of the scores of the first 11 pain descriptors (throbbing, shooting, stabbing, sharp, cramping, gnawing, hot-burning, aching, heavy, tender, and splitting) and could range from 0-33. The affective score was the sum of the scores of the last 4 pain descriptors (tiring-exhausting, sickening, fearful, and punishing-cruel) and could range from 0-12. The total score was the sum of the scores of all 15 pain descriptors and could range from 0 to 45. Higher scores indicated greater pain.
- Baseline Pain Visual Analogue Scale (VAS) and Present Pain Intensity (PPI) Scale [Baseline]
The VAS was part of the Short Form McGill Pain Questionnaire (SF-MPQ) scale and reflected the overall pain intensity score, The pain VAS was a horizontal line; 100 millimeters (mm) in length, was self-administered by the participant in order to rate pain from 0 (no pain) to 100 (worst possible pain). The PPI was part of the SF-MPQ scale and measured the participant's present pain intensity on a 6-point scale ranging from 0 (no pain) to 5 (excruciating).
- Change From Baseline in Pain VAS From the SF-MPQ at Endpoint [Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)]
The VAS was part of the SF-MPQ scale and reflected the overall pain intensity score. The pain VAS was a horizontal line; 100 mm in length, was self-administered by the participant in order to rate pain from 0 (no pain) to 100 (worst possible pain).
- Change From Baseline in PPI Scale From the SF-MPQ at Endpoint [Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)]
The PPI was part of the SF-MPQ scale and measured the participant's present pain intensity on a 6-point scale ranging from 0 (no pain) to 5 (excruciating).
- Baseline Medical Outcomes Study (MOS)-Sleep Scale Scores [Baseline]
The MOS-Sleep Scale was a participant-rated instrument which assesses sleep quantity and quality with 12 items (7 subscale scores: sleep disturbance, snoring, awakening short of breath/with headache, sleep adequacy, somnolence, sleep quantity, optimal sleep; and a 9-item overall sleep problems index). Subscale scores total range: 0-100 (except sleep quantity [range 0-24 hours], optimal sleep [yes:1, no:0]). Higher scores=poorer sleep outcomes (except sleep quantity, adequacy, and optimal sleep).
- Change From Baseline in MOS-Sleep Scale, Sleep Disturbance Score at Endpoint [Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)]
The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. For sleep disturbance, the subscale score also ranged from 0 to 100, with higher scores representing greater sleep disturbance.
- Change From Baseline in MOS-Sleep Scale, Snoring Score at Endpoint [Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)]
The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The snoring subscale score also ranged from 0 to 100, with lower scores indicating less snoring.
- Change From Baseline in MOS-Sleep Scale, Awaken Short of Breath Score at Endpoint [Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)]
The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The awaken short of breath subscale also ranged from 0 to 100, with lower scores indicating less difficulty in breathing.
- Change From Baseline in MOS-Sleep Scale, Quantity of Sleep Score at Endpoint [Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)]
The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The MOS Sleep Quantity sub-scale scores ranged from 0 to 24 (number of hours slept).
- Percentage of Participants Who Had Optimal Sleep at Endpoint [Day 63 (Week 9)/Early Termination (Study Endpoint)]
The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The MOS optimal sleep subscale was a binary outcome derived from the sleep quantity responses: the response was YES if sleep quantity was 7 or 8 hours per night.
- Change From Baseline in MOS-Sleep Scale, Sleep Adequacy Score at Endpoint [Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)]
The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The sleep adequacy subscale also ranged from 0 to 100, with higher scores indicating greater sleep adequacy.
- Change From Baseline in MOS-Sleep Scale, Somnolence Score at Endpoint [Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)]
The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The somnolence subscale score also ranged from 0 to 100, with lower scores indicating less somnolence.
- Change From Baseline in MOS-Sleep Scale, Sleep Problems Index Score at Endpoint [Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)]
The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The sleep problems index subscale score also ranged from 0 to 100, with lower scores indicating fewer sleep problems.
- Clinical Global Impression of Change (CGIC) at Endpoint [Day 63 (Week 9)/Early Termination (Study Endpoint)]
The CGIC was a clinician-rated global measure that provided a clinically relevant and easy to interpret account of a clinician's perception of the clinical importance of the participant's improvement or worsening during their involvement in a clinical study. Clinicians rated the participant's overall improvement on a 7-point scale where scores ranged from 1 (very much improved) to 7 (very much worse).
- Patient Global Impression of Change (PGIC) Score at Endpoint [Day 63 (Week 9)/Early Termination (Study Endpoint)]
The PGIC was a participant-rated global measure that provided a clinically relevant and easy to interpret account of a participant's perception of the clinical importance of their own improvement or worsening during their involvement in a clinical study. Participants rated their overall improvement on a 7-point scale where scores ranged from 1 (very much improved) to 7 (very much worse).
- Baseline Hospital Anxiety and Depression Scale (HADS) Scores [Baseline]
The HADS was a self-administered questionnaire that consisted of 2 subscales, 1 measuring anxiety (HADS-A Scale) and the other measuring depression (HADS-D Scale). Each subscale comprised of 7 items; participants assessed how each item applied to them on a scale of 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Subscores from HADS-A (Anxiety) and HADS-D (Depression) were not to be combined. The interpretation of each HADS subscales was as follows: 0-7 normal, 8-10 mild, 11-14 moderate and 15-21 severe.
- Change From Baseline in HADS Anxiety Total Score at Endpoint [Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)]
The HADS was a self-administered questionnaire that consisted of 2 subscales, 1 measuring anxiety (HADS-A Scale) and the other measuring depression (HADS-D Scale). Each subscale was comprised of 7 items; participants assessed how each item applied to them on a scale of 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Subscores from HADS-A (Anxiety) and HADS-D (Depression) were not to be combined. The interpretation of each HADS subscales was as follows: 0-7 normal, 8-10 mild, 11-14 moderate and 15-21 severe.
- Change From Baseline in HADS Depression Total Score at Endpoint [Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)]
The HADS was a self-administered questionnaire that consisted of 2 subscales, 1 measuring anxiety (HADS-A Scale) and the other measuring depression (HADS-D Scale). Each subscale was comprised of 7 items; participants assessed how each item applied to them on a scale of 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Subscores from HADS-A (Anxiety) and HADS-D (Depression) were not to be combined. The interpretation of each HADS subscales was as follows: 0-7 normal, 8-10 mild, 11-14 moderate and 15-21 severe.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Male and female subjects aged 18 years or older
-
Diagnosis of painful, distal, symmetrical, sensorimotor polyneuropathy which is due to diabetes mellitus (Type 1 or 2), and symptoms of painful diabetic neuropathy for 6 months to 5 years (inclusive).
-
At the baseline and randomization visits, a score of ≥50 mm on the Visual Analogue Scale, at randomization, subjects must have completed at least 5 daily pain interference diaries, and have an average daily pain score of ≥5 over the past 7 days.
-
Patient who are willing and capable to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
-
Women of childbearing potential are willing to use contraception during study.
Exclusion Criteria:
-
Subjects with more than 30% decrease on the Pain Visual Analog Scale at randomization as compared to screening; and during the 1 week screening period, with more than one pain score <3 in pain scores.
-
Subject has other kinds of neurological disorder, pain of other reason, or skin condition that could confuse the assessment.
-
Subject with any other serious or unstable condition which in the opinion of the investigator might compromise participation in the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Southwest hospital of the third military medical university/Department of Neurology | Chongqing | Chongqing | China | 400038 |
| 2 | Fuzhou General Hospital of Nanjing Military Command | Fuzhou | Fujian | China | 350025 |
| 3 | Department of Endocrinology, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Guangzhou | Guangdong | China | 510120 |
| 4 | The Second Affiliated Hospital of Guangzhou Medical University | Guangzhou | Guangdong | China | 510260 |
| 5 | Nanfang Hospital, Southern Medical University | Guangzhou | Guangdong | China | 510515 |
| 6 | Dept. of Endocrinology, The first Affiliated Hospital of Harbin Medical University | Harbin | Heilongjiang | China | 150001 |
| 7 | Dept. of Endocrinology, The second Affiliated Hospital of Harbin Medical University | Harbin | Heilongjiang | China | 150086 |
| 8 | Tongji Hospital,Tongji Medical College Huazhong University of Science & Technology | Wuhan | Hubei | China | 430030 |
| 9 | Xiangya Hospital of Centre-south University | Changsha | Hunan | China | 410008 |
| 10 | Jiangsu Province Hospital | Nanjing | Jiangsu | China | 210029 |
| 11 | The First Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | China | 330006 |
| 12 | Dept. of Endocrinology, The second hospital of Jilin University | Changchun | Jilin | China | 130041 |
| 13 | Shengjing hospital of china medical university | Shenyang | Liaoning | China | 110004 |
| 14 | Qilu Hospital of Shandong University/department of internal neurology | Jinan | Shandong | China | 250012 |
| 15 | Qilu Hospital of Shandong University | Jinan | Shandong | China | 250012 |
| 16 | Tianjin Medical University General Hospital | Tianjin | Tianjin | China | 300052 |
| 17 | The Second Affiliated Hospital Zhejiang University College of Medicine | Hangzhou | Zhejiang | China | 310009 |
| 18 | Sir Run Run Shaw Hospital, School of medicine, Zhejiang University | Hangzhou | Zhejiang | China | 310016 |
| 19 | Beijing Tiantan Hospital affiliated to Capital Medical University, Neurology Department | Beijing | China | 100050 | |
| 20 | Peking University Third Hospital | Beijing | China | 100191 | |
| 21 | Endocrinology Department | Beijing | China | 100700 | |
| 22 | Beijing Hospital of the Ministry of Health | Beijing | China | 100730 | |
| 23 | Tongren Hospital Affiliated to Capital Medical University | Beijing | China | 100730 | |
| 24 | Chinese PLA General Hospital | Beijing | China | 100853 | |
| 25 | GuangZhou First Municipal People's Hospital | Guangzhou | China | 510180 | |
| 26 | Huashan Hospital Affiliated Fudan University, Neurology Department | Shang Hai | China | 200040 | |
| 27 | Shanghai Changzheng Hospital | Shanghai | China | 200003 | |
| 28 | Shanghai Tenth People's Hospital/The Endocrinology Department | Shanghai | China | 200072 | |
| 29 | Shanghai First People's Hospital | Shanghai | China | 200080 | |
| 30 | Renji Hospital Shanghai Jiao Tong University School of Medicine/Neurology Department | Shanghai | China | 200127 |
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:
NCT01332149
Other Study ID Numbers:
- A0081265
First Posted:
Apr 8, 2011
Last Update Posted:
Jan 28, 2021
Last Verified:
Jun 1, 2015
Keywords provided by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | All participants were Chinese. 626 participants were randomized initially, as originally stated on clinicaltrials.gov. However, 3 participants discontinued right after randomization without any treatment information. As such, the actual number of participants randomized and assigned to treatment was 623 as stated in the "Started" Row below. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Pregabalin | Placebo |
|---|---|---|
| Arm/Group Description | Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day). | Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period. |
| Period Title: Overall Study | ||
| STARTED | 314 | 309 |
| Treated | 313 | 307 |
| COMPLETED | 284 | 271 |
| NOT COMPLETED | 30 | 38 |
Baseline Characteristics
| Arm/Group Title | Pregabalin | Placebo | Total |
|---|---|---|---|
| Arm/Group Description | Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day). | Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period. | Total of all reporting groups |
| Overall Participants | 313 | 307 | 620 |
| Age, Customized (participants) [Number] | |||
| 18-44 years |
25
(10.3)
8%
|
15
(9.5)
4.9%
|
40
6.5%
|
| 45-64 years |
172
55%
|
178
58%
|
350
56.5%
|
| More than or equal to (>=) 65 years |
116
37.1%
|
114
37.1%
|
230
37.1%
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
159
50.8%
|
168
54.7%
|
327
52.7%
|
| Male |
154
49.2%
|
139
45.3%
|
293
47.3%
|
Outcome Measures
| Title | Baseline Mean Pain Score |
|---|---|
| Description | The daily pain rating scale (DPRS) consists of an 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10. |
| Time Frame | Baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants in the Full Analysis Set (FAS) population, consisting of all participants randomized to treatment that received at least 1 dose of study medication. |
| Arm/Group Title | Pregabalin | Placebo |
|---|---|---|
| Arm/Group Description | Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day). | Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period. |
| Measure Participants | 313 | 307 |
| Mean (Standard Deviation) [units on a scale] |
6.65
(1.117)
|
6.67
(1.150)
|
| Title | Change From Baseline in Mean Pain Score at Endpoint |
|---|---|
| Description | The daily pain rating scale (DPRS) consists of an 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10. The mean endpoint pain score was obtained from the last 7 available DPRS scores of the daily pain diary while the participant was on study medication, up to and including the day after the last Week 8 (Day 57) dose. |
| Time Frame | Baseline and end of fixed dose phase (Day 63/Week 9)/Early Termination (Study Endpoint) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants in the Full Analysis Set (FAS) population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The Last Observation Carried Forward (LOCF) method was used. |
| Arm/Group Title | Pregabalin | Placebo |
|---|---|---|
| Arm/Group Description | Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day). | Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period. |
| Measure Participants | 312 | 307 |
| Least Squares Mean (Standard Error) [units on a scale] |
-2.14
(0.115)
|
-1.86
(0.117)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0559 |
| Comments | Primary analysis was two-sided and performed at the 0.05 significance level. No multiple comparisons adjustment was made. | |
| Method | ANCOVA | |
| Comments | The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model. | |
| Method of Estimation | Estimation Parameter | Least Squares (LS) Mean Difference |
| Estimated Value | -0.28 | |
| Confidence Interval |
(2-Sided) 95% -0.58 to 0.01 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.148 |
|
| Estimation Comments | ||
| Title | Change From Baseline in Weekly Mean Pain Score at Weeks 1 to 9 |
|---|---|
| Description | The DPRS consists of an 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10. The weekly mean pain score was the sum of the daily scores divided by the number of diary entries during that week. The overall change is the average change from Weeks 1 to 9. |
| Time Frame | Baseline and weekly from Weeks 1 to 9 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The FAS population consisted of all participants randomized to treatment that received at least 1 dose of study medication. N=number of evaluable participants at the specified time point. |
| Arm/Group Title | Pregabalin | Placebo |
|---|---|---|
| Arm/Group Description | Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day). | Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period. |
| Measure Participants | 313 | 307 |
| Week 1 change from baseline (N=312, 307) |
-0.60
(0.091)
|
-0.36
(0.092)
|
| Week 2 change from baseline (N=304, 295) |
-0.97
(0.092)
|
-0.71
(0.093)
|
| Week 3 change from baseline (N=298, 291) |
-1.25
(0.092)
|
-1.01
(0.093)
|
| Week 4 change from baseline (N=297, 289) |
-1.47
(0.092)
|
-1.21
(0.093)
|
| Week 5 change from baseline (N=296, 287) |
-1.61
(0.092)
|
-1.39
(0.093)
|
| Week 6 change from baseline (N=293, 278) |
-1.84
(0.092)
|
-1.59
(0.094)
|
| Week 7 change from baseline (N=290, 275) |
-2.04
(0.092)
|
-1.77
(0.094)
|
| Week 8 change from baseline (N=290, 275) |
-2.18
(0.092)
|
-1.88
(0.094)
|
| Week 9 change from baseline (N=287, 273) |
-2.32
(0.092)
|
-2.07
(0.094)
|
| Overall change from baseline |
-1.59
(0.082)
|
-1.33
(0.083)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | Week 1 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0527 |
| Comments | All analyses were two-sided and performed at the 0.05 significance level. | |
| Method | Mixed Model Repeated Measures Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.23 | |
| Confidence Interval |
(2-Sided) 95% -0.47 to 0.00 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.120 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | Week 2 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0279 |
| Comments | All analyses were two-sided and performed at the 0.05 significance level. | |
| Method | Mixed Model Repeated Measures Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.27 | |
| Confidence Interval |
(2-Sided) 95% -0.50 to -0.03 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.121 |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | Week 3 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0508 |
| Comments | All analyses were two-sided and performed at the 0.05 significance level. | |
| Method | Mixed Model Repeated Measures Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.24 | |
| Confidence Interval |
(2-Sided) 95% -0.48 to 0.00 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.121 |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | Week 4 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0349 |
| Comments | All analyses were two-sided and performed at the 0.05 significance level. | |
| Method | Mixed Model Repeated Measures Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.26 | |
| Confidence Interval |
(2-Sided) 95% -0.49 to -0.02 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.121 |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | Week 5 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0672 |
| Comments | All analyses were two-sided and performed at the 0.05 significance level. | |
| Method | Mixed Model Repeated Measures Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.22 | |
| Confidence Interval |
(2-Sided) 95% -0.46 to 0.02 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.122 |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | Week 6 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0469 |
| Comments | All analyses were two-sided and performed at the 0.05 significance level. | |
| Method | Mixed Model Repeated Measures Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.24 | |
| Confidence Interval |
(2-Sided) 95% -0.48 to -0.00 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.122 |
|
| Estimation Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | Week 7 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0280 |
| Comments | All analyses were two-sided and performed at the 0.05 significance level. | |
| Method | Mixed Model Repeated Measures Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.27 | |
| Confidence Interval |
(2-Sided) 95% -0.51 to -0.03 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.122 |
|
| Estimation Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | Week 8 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0140 |
| Comments | All analyses were two-sided and performed at the 0.05 significance level. | |
| Method | Mixed Model Repeated Measures Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.30 | |
| Confidence Interval |
(2-Sided) 95% -0.54 to -0.06 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.122 |
|
| Estimation Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | Week 9 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0375 |
| Comments | All analyses were two-sided and performed at the 0.05 significance level. | |
| Method | Mixed Model Repeated Measures Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.25 | |
| Confidence Interval |
(2-Sided) 95% -0.49 to -0.01 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.122 |
|
| Estimation Comments | ||
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | Overall change from baseline analysis. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0164 |
| Comments | All analyses were two-sided and performed at the 0.05 significance level. | |
| Method | Mixed Model Repeated Measures Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.25 | |
| Confidence Interval |
(2-Sided) 95% -0.46 to -0.05 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.105 |
|
| Estimation Comments | Overall change was estimated from the mixed effect model treatment main effect. | |
| Title | Baseline Mean Sleep Interference Score |
|---|---|
| Description | Pain-related sleep interference was assessed on an 11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]). Participants were to describe how their pain had interfered with their sleep during the past 24 hours by choosing the appropriate number between 0 and 10. |
| Time Frame | Baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants in the Full Analysis Set (FAS) population, consisting of all participants randomized to treatment that received at least 1 dose of study medication. |
| Arm/Group Title | Pregabalin | Placebo |
|---|---|---|
| Arm/Group Description | Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day). | Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period. |
| Measure Participants | 313 | 307 |
| Mean (Standard Deviation) [units on a scale] |
5.25
(2.236)
|
5.12
(2.278)
|
| Title | Change From Baseline in Mean Sleep Interference Score at Endpoint |
|---|---|
| Description | Pain-related sleep interference was assessed on an 11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]). Participants were to describe how their pain had interfered with their sleep during the past 24 hours by choosing the appropriate number between 0 and 10. The mean endpoint score was obtained from the last 7 available scores of the daily diary while the participant was on study medication, up to and including the day after the last Week 9 (Day 63) dose. |
| Time Frame | Baseline and end of fixed dose phase (Day 63/Week 9)/Early Termination (Study Endpoint) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used. |
| Arm/Group Title | Pregabalin | Placebo |
|---|---|---|
| Arm/Group Description | Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day). | Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period. |
| Measure Participants | 311 | 307 |
| Least Squares Mean (Standard Error) [units on a scale] |
-1.52
(0.110)
|
-1.30
(0.112)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1340 |
| Comments | Analysis was two-sided and performed at the 0.05 significance level. | |
| Method | ANCOVA | |
| Comments | The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model. | |
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.21 | |
| Confidence Interval |
(2-Sided) 95% -0.49 to 0.07 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.143 |
|
| Estimation Comments | ||
| Title | Change From Baseline in Weekly Mean Sleep Interference Score at Weeks 1 to 9 |
|---|---|
| Description | Pain-related sleep interference was assessed on an 11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]). Participants were to describe how their pain had interfered with their sleep during the past 24 hours by choosing the appropriate number between 0 and 10. The weekly mean score was the sum of the daily scores divided by the number of diary entries during that week. The overall change is the average change from Weeks 1 to 9. |
| Time Frame | Baseline and weekly from Weeks 1 to 9 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The FAS population consisted of all participants randomized to treatment that received at least 1 dose of study medication. N=number of evaluable participants at the specified time point. |
| Arm/Group Title | Pregabalin | Placebo |
|---|---|---|
| Arm/Group Description | Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day). | Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period. |
| Measure Participants | 313 | 307 |
| Week 1 change from baseline (N=311, 307) |
-0.38
(0.096)
|
-0.26
(0.098)
|
| Week 2 change from baseline (N=303, 295) |
-0.66
(0.097)
|
-0.51
(0.098)
|
| Week 3 change from baseline (N=297, 291) |
-0.88
(0.097)
|
-0.72
(0.099)
|
| Week 4 change from baseline (N=296, 289) |
-1.06
(0.097)
|
-0.86
(0.099)
|
| Week 5 change from baseline (N=295, 287) |
-1.14
(0.097)
|
-0.98
(0.099)
|
| Week 6 change from baseline (N=292, 278) |
-1.32
(0.098)
|
-1.07
(0.099)
|
| Week 7 change from baseline (N=289, 275) |
-1.43
(0.098)
|
-1.25
(0.099)
|
| Week 8 change from baseline (N=289, 275) |
-1.59
(0.098)
|
-1.36
(0.099)
|
| Week 9 change from baseline (N=286, 273) |
-1.67
(0.098)
|
-1.49
(0.100)
|
| Overall change from baseline |
-1.13
(0.085)
|
-0.94
(0.087)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | Week 1 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3438 |
| Comments | Analysis was two-sided and performed at the 0.05 significance level. | |
| Method | Mixed Model Repeated Measures Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.12 | |
| Confidence Interval |
(2-Sided) 95% -0.37 to 0.13 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.127 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | Week 2 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2482 |
| Comments | Analysis was two-sided and performed at the 0.05 significance level. | |
| Method | Mixed Model Repeated Measures Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.15 | |
| Confidence Interval |
(2-Sided) 95% -0.40 to 0.10 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.128 |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | Week 3 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2249 |
| Comments | Analysis was two-sided and performed at the 0.05 significance level. | |
| Method | Mixed Model Repeated Measures Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.16 | |
| Confidence Interval |
(2-Sided) 95% -0.41 to 0.10 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.129 |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | Week 4 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1094 |
| Comments | Analysis was two-sided and performed at the 0.05 significance level. | |
| Method | Mixed Model Repeated Measures Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.21 | |
| Confidence Interval |
(2-Sided) 95% -0.46 to 0.05 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.129 |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | Week 5 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2095 |
| Comments | Analysis was two-sided and performed at the 0.05 significance level. | |
| Method | Mixed Model Repeated Measures Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.16 | |
| Confidence Interval |
(2-Sided) 95% -0.41 to 0.09 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.129 |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | Week 6 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0531 |
| Comments | Analysis was two-sided and performed at the 0.05 significance level. | |
| Method | Mixed Model Repeated Measures Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.25 | |
| Confidence Interval |
(2-Sided) 95% -0.50 to 0.00 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.129 |
|
| Estimation Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | Week 7 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1628 |
| Comments | Analysis was two-sided and performed at the 0.05 significance level. | |
| Method | Mixed Model Repeated Measures Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.18 | |
| Confidence Interval |
(2-Sided) 95% -0.44 to 0.07 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.130 |
|
| Estimation Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | Week 8 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0770 |
| Comments | Analysis was two-sided and performed at the 0.05 significance level. | |
| Method | Mixed Model Repeated Measures Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.23 | |
| Confidence Interval |
(2-Sided) 95% -0.48 to 0.02 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.130 |
|
| Estimation Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | Week 9 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1651 |
| Comments | Analysis was two-sided and performed at the 0.05 significance level. | |
| Method | Mixed Model Repeated Measures Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.18 | |
| Confidence Interval |
(2-Sided) 95% -0.43 to 0.07 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.130 |
|
| Estimation Comments | ||
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | Overall change from baseline analysis. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1006 |
| Comments | Analysis was two-sided and performed at the 0.05 significance level. | |
| Method | Mixed Model Repeated Measures Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.18 | |
| Confidence Interval |
(2-Sided) 95% -0.40 to 0.04 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.110 |
|
| Estimation Comments | ||
| Title | Percentage of 30 Percent (%) Responders at Endpoint |
|---|---|
| Description | The DPRS consists of an 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10. A 30% responder was a participant who had 30% reduction or more in mean pain score at the end of the fixed dose phase (Day 63/Week 9) (Study Endpoint) compared to baseline. |
| Time Frame | End of fixed dose phase (Day 63/Week 9)/Early Termination (Study Endpoint) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used. |
| Arm/Group Title | Pregabalin | Placebo |
|---|---|---|
| Arm/Group Description | Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day). | Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period. |
| Measure Participants | 312 | 307 |
| Number [percentage of participants] |
50.3
(0.115)
16.1%
|
44.3
(0.117)
14.4%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1309 |
| Comments | Analysis was two-sided and performed at the 0.05 significance level. | |
| Method | Cochran-Mantel-Haenszel | |
| Comments | Cochran-Mantel-Haenszel test comparing pregabalin to placebo adjusted for center. | |
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 1.27 | |
| Confidence Interval |
(2-Sided) 95% 0.93 to 1.74 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change From Baseline in Short Form McGill Pain Questionnaire (SF-MPQ) Score at Weeks 1, 5, and 9 |
|---|---|
| Description | SF-MPQ was assessed according to the participant's answer to the SF-MPQ questionnaire. The score for each composite scale (sensory, affective, and total) was derived by summing the reported intensity value for each item within a particular scale where None=0, Mild=1, Moderate=2, and Severe=3. The sensory score was the sum of the scores of the first 11 pain descriptors (throbbing, shooting, stabbing, sharp, cramping, gnawing, hot-burning, aching, heavy, tender, and splitting) and could range from 0-33. The affective score was the sum of the scores of the last 4 pain descriptors (tiring-exhausting, sickening, fearful, and punishing-cruel) and could range from 0-12. The total score was the sum of the scores of all 15 pain descriptors and could range from 0 to 45. Higher scores indicated greater pain. |
| Time Frame | Baseline; Weeks 1, 5, and 9 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The FAS population consisted of all participants randomized to treatment that received at least 1 dose of study medication. N=number of evaluable participants at the specified time point. No inferential analyses were performed. |
| Arm/Group Title | Pregabalin | Placebo |
|---|---|---|
| Arm/Group Description | Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day). | Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period. |
| Measure Participants | 313 | 307 |
| Sensory score, Baseline (N=313, 306) |
7.90
(5.101)
|
8.11
(5.098)
|
| Sensory score, Week 1 change (N=311, 304) |
-1.50
(3.422)
|
-1.34
(3.134)
|
| Sensory score, Week 5 change (N=297, 288) |
-2.89
(4.244)
|
-2.47
(3.925)
|
| Sensory score, Week 9 change (N=288, 274) |
-3.87
(4.432)
|
-3.37
(4.348)
|
| Affective score, Baseline (N=313, 307) |
1.25
(1.809)
|
1.20
(1.817)
|
| Affective score, Week 1 change (N=311, 304) |
-0.41
(1.569)
|
-0.37
(1.410)
|
| Affective score, Week 5 change (N=297, 289) |
-0.72
(1.724)
|
-0.62
(1.652)
|
| Affective score, Week 9 change (N=287, 274) |
-0.75
(1.744)
|
-0.62
(1.792)
|
| Total score, Baseline (N=313, 307) |
9.15
(6.118)
|
9.28
(6.445)
|
| Total score, Week 1 change (N=311, 305) |
-1.92
(4.260)
|
-1.70
(3.908)
|
| Total score, Week 5 change (N=297, 289) |
-3.61
(5.084)
|
-3.07
(4.893)
|
| Total score, Week 9 change (N=288, 274) |
-4.62
(5.272)
|
-4.00
(5.512)
|
| Title | Baseline Pain Visual Analogue Scale (VAS) and Present Pain Intensity (PPI) Scale |
|---|---|
| Description | The VAS was part of the Short Form McGill Pain Questionnaire (SF-MPQ) scale and reflected the overall pain intensity score, The pain VAS was a horizontal line; 100 millimeters (mm) in length, was self-administered by the participant in order to rate pain from 0 (no pain) to 100 (worst possible pain). The PPI was part of the SF-MPQ scale and measured the participant's present pain intensity on a 6-point scale ranging from 0 (no pain) to 5 (excruciating). |
| Time Frame | Baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants in the FAS population, consisting of all participants randomized to treatment that received at least 1 dose of study medication. |
| Arm/Group Title | Pregabalin | Placebo |
|---|---|---|
| Arm/Group Description | Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day). | Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period. |
| Measure Participants | 313 | 307 |
| VAS |
69.08
(11.474)
|
69.06
(11.811)
|
| PPI |
2.28
(0.784)
|
2.27
(0.830)
|
| Title | Change From Baseline in Pain VAS From the SF-MPQ at Endpoint |
|---|---|
| Description | The VAS was part of the SF-MPQ scale and reflected the overall pain intensity score. The pain VAS was a horizontal line; 100 mm in length, was self-administered by the participant in order to rate pain from 0 (no pain) to 100 (worst possible pain). |
| Time Frame | Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used. |
| Arm/Group Title | Pregabalin | Placebo |
|---|---|---|
| Arm/Group Description | Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day). | Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period. |
| Measure Participants | 310 | 304 |
| Least Squares Mean (Standard Error) [units on a scale] |
-25.07
(1.260)
|
-21.82
(1.279)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0463 |
| Comments | Analysis was two-sided and performed at the 0.05 significance level. | |
| Method | ANCOVA | |
| Comments | The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model. | |
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -3.25 | |
| Confidence Interval |
(2-Sided) 95% -6.45 to -0.05 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.628 |
|
| Estimation Comments | ||
| Title | Change From Baseline in PPI Scale From the SF-MPQ at Endpoint |
|---|---|
| Description | The PPI was part of the SF-MPQ scale and measured the participant's present pain intensity on a 6-point scale ranging from 0 (no pain) to 5 (excruciating). |
| Time Frame | Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used. |
| Arm/Group Title | Pregabalin | Placebo |
|---|---|---|
| Arm/Group Description | Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day). | Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period. |
| Measure Participants | 309 | 305 |
| Least Squares Mean (Standard Error) [units on a scale] |
-0.80
(0.047)
|
-0.73
(0.048)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2748 |
| Comments | Analysis was two-sided and performed at the 0.05 significance level. | |
| Method | ANCOVA | |
| Comments | The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model. | |
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.07 | |
| Confidence Interval |
(2-Sided) 95% -0.19 to 0.05 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.061 |
|
| Estimation Comments | ||
| Title | Baseline Medical Outcomes Study (MOS)-Sleep Scale Scores |
|---|---|
| Description | The MOS-Sleep Scale was a participant-rated instrument which assesses sleep quantity and quality with 12 items (7 subscale scores: sleep disturbance, snoring, awakening short of breath/with headache, sleep adequacy, somnolence, sleep quantity, optimal sleep; and a 9-item overall sleep problems index). Subscale scores total range: 0-100 (except sleep quantity [range 0-24 hours], optimal sleep [yes:1, no:0]). Higher scores=poorer sleep outcomes (except sleep quantity, adequacy, and optimal sleep). |
| Time Frame | Baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. N=number of evaluable participants for each category |
| Arm/Group Title | Pregabalin | Placebo |
|---|---|---|
| Arm/Group Description | Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day). | Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period. |
| Measure Participants | 313 | 307 |
| Sleep disturbance score (N=313, 307) |
36.29
(24.768)
|
35.13
(26.915)
|
| Snoring score (N=312, 307) |
35.13
(36.670)
|
37.59
(37.163)
|
| Awaken short of breath score (N=313, 307) |
11.50
(21.557)
|
10.75
(21.883)
|
| Quantity of sleep score (N=311, 304) |
6.07
(2.882)
|
5.98
(1.451)
|
| Sleep adequacy score (N=313, 307) |
57.32
(31.518)
|
60.88
(30.274)
|
| Somnolence score (N=312, 307) |
33.87
(20.459)
|
36.03
(21.491)
|
| Sleep problems index score (N=312, 307) |
32.19
(19.806)
|
31.21
(20.388)
|
| Title | Change From Baseline in MOS-Sleep Scale, Sleep Disturbance Score at Endpoint |
|---|---|
| Description | The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. For sleep disturbance, the subscale score also ranged from 0 to 100, with higher scores representing greater sleep disturbance. |
| Time Frame | Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used. |
| Arm/Group Title | Pregabalin | Placebo |
|---|---|---|
| Arm/Group Description | Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day). | Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period. |
| Measure Participants | 297 | 286 |
| Least Squares Mean (Standard Error) [units on a scale] |
-9.11
(1.222)
|
-7.98
(1.244)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4758 |
| Comments | Analysis was two-sided and performed at the 0.05 significance level. | |
| Method | ANCOVA | |
| Comments | The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model. | |
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.13 | |
| Confidence Interval |
(2-Sided) 95% -4.22 to 1.97 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.577 |
|
| Estimation Comments | ||
| Title | Change From Baseline in MOS-Sleep Scale, Snoring Score at Endpoint |
|---|---|
| Description | The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The snoring subscale score also ranged from 0 to 100, with lower scores indicating less snoring. |
| Time Frame | Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used. |
| Arm/Group Title | Pregabalin | Placebo |
|---|---|---|
| Arm/Group Description | Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day). | Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period. |
| Measure Participants | 295 | 285 |
| Least Squares Mean (Standard Error) [units on a scale] |
2.78
(1.716)
|
-0.53
(1.743)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1363 |
| Comments | Analysis was two-sided and performed at the 0.05 significance level. | |
| Method | ANCOVA | |
| Comments | The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model. | |
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | 3.31 | |
| Confidence Interval |
(2-Sided) 95% -1.05 to 7.67 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.220 |
|
| Estimation Comments | ||
| Title | Change From Baseline in MOS-Sleep Scale, Awaken Short of Breath Score at Endpoint |
|---|---|
| Description | The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The awaken short of breath subscale also ranged from 0 to 100, with lower scores indicating less difficulty in breathing. |
| Time Frame | Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used. |
| Arm/Group Title | Pregabalin | Placebo |
|---|---|---|
| Arm/Group Description | Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day). | Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period. |
| Measure Participants | 295 | 286 |
| Least Squares Mean (Standard Error) [units on a scale] |
-2.10
(1.061)
|
-2.31
(1.078)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8808 |
| Comments | Analysis was two-sided and performed at the 0.05 significance level. | |
| Method | ANCOVA | |
| Comments | The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model. | |
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | 0.21 | |
| Confidence Interval |
(2-Sided) 95% -2.49 to 2.90 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.371 |
|
| Estimation Comments | ||
| Title | Change From Baseline in MOS-Sleep Scale, Quantity of Sleep Score at Endpoint |
|---|---|
| Description | The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The MOS Sleep Quantity sub-scale scores ranged from 0 to 24 (number of hours slept). |
| Time Frame | Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used. |
| Arm/Group Title | Pregabalin | Placebo |
|---|---|---|
| Arm/Group Description | Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day). | Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period. |
| Measure Participants | 295 | 280 |
| Least Squares Mean (Standard Error) [units on a scale] |
0.33
(0.085)
|
0.14
(0.087)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0887 |
| Comments | Analysis was two-sided and performed at the 0.05 significance level. | |
| Method | ANCOVA | |
| Comments | The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model. | |
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | 0.19 | |
| Confidence Interval |
(2-Sided) 95% -0.03 to 0.40 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.110 |
|
| Estimation Comments | ||
| Title | Percentage of Participants Who Had Optimal Sleep at Endpoint |
|---|---|
| Description | The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The MOS optimal sleep subscale was a binary outcome derived from the sleep quantity responses: the response was YES if sleep quantity was 7 or 8 hours per night. |
| Time Frame | Day 63 (Week 9)/Early Termination (Study Endpoint) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used. |
| Arm/Group Title | Pregabalin | Placebo |
|---|---|---|
| Arm/Group Description | Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day). | Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period. |
| Measure Participants | 297 | 282 |
| Number [percentage of participants] |
43.8
(0.085)
14%
|
45.0
(0.087)
14.7%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | Analysis performed using a logistic regression model with treatment and center as factors, and baseline value as a covariate. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7929 |
| Comments | Analysis was two-sided and performed at the 0.05 significance level. | |
| Method | Regression, Logistic | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 1.05 | |
| Confidence Interval |
(2-Sided) 95% 0.72 to 1.53 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change From Baseline in MOS-Sleep Scale, Sleep Adequacy Score at Endpoint |
|---|---|
| Description | The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The sleep adequacy subscale also ranged from 0 to 100, with higher scores indicating greater sleep adequacy. |
| Time Frame | Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used. |
| Arm/Group Title | Pregabalin | Placebo |
|---|---|---|
| Arm/Group Description | Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day). | Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period. |
| Measure Participants | 297 | 285 |
| Least Squares Mean (Standard Error) [units on a scale] |
8.87
(1.532)
|
7.82
(1.552)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5960 |
| Comments | Analysis was two-sided and performed at the 0.05 significance level. | |
| Method | ANCOVA | |
| Comments | The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model. | |
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | 1.05 | |
| Confidence Interval |
(2-Sided) 95% -2.83 to 4.92 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.973 |
|
| Estimation Comments | ||
| Title | Change From Baseline in MOS-Sleep Scale, Somnolence Score at Endpoint |
|---|---|
| Description | The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The somnolence subscale score also ranged from 0 to 100, with lower scores indicating less somnolence. |
| Time Frame | Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used. |
| Arm/Group Title | Pregabalin | Placebo |
|---|---|---|
| Arm/Group Description | Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day). | Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period. |
| Measure Participants | 295 | 285 |
| Least Squares Mean (Standard Error) [units on a scale] |
-1.22
(1.187)
|
-0.88
(1.208)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8216 |
| Comments | Analysis was two-sided and performed at the 0.05 significance level. | |
| Method | ANCOVA | |
| Comments | The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model. | |
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.35 | |
| Confidence Interval |
(2-Sided) 95% -3.36 to 2.67 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.536 |
|
| Estimation Comments | ||
| Title | Change From Baseline in MOS-Sleep Scale, Sleep Problems Index Score at Endpoint |
|---|---|
| Description | The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The sleep problems index subscale score also ranged from 0 to 100, with lower scores indicating fewer sleep problems. |
| Time Frame | Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used. |
| Arm/Group Title | Pregabalin | Placebo |
|---|---|---|
| Arm/Group Description | Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day). | Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period. |
| Measure Participants | 294 | 284 |
| Least Squares Mean (Standard Error) [units on a scale] |
-6.71
(0.914)
|
-5.88
(0.927)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4829 |
| Comments | Analysis was two-sided and performed at the 0.05 significance level. | |
| Method | ANCOVA | |
| Comments | The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model. | |
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.83 | |
| Confidence Interval |
(2-Sided) 95% -3.14 to 1.49 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.177 |
|
| Estimation Comments | ||
| Title | Clinical Global Impression of Change (CGIC) at Endpoint |
|---|---|
| Description | The CGIC was a clinician-rated global measure that provided a clinically relevant and easy to interpret account of a clinician's perception of the clinical importance of the participant's improvement or worsening during their involvement in a clinical study. Clinicians rated the participant's overall improvement on a 7-point scale where scores ranged from 1 (very much improved) to 7 (very much worse). |
| Time Frame | Day 63 (Week 9)/Early Termination (Study Endpoint) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used. |
| Arm/Group Title | Pregabalin | Placebo |
|---|---|---|
| Arm/Group Description | Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day). | Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period. |
| Measure Participants | 299 | 290 |
| Least Squares Mean (Standard Error) [units on a scale] |
2.58
(0.057)
|
2.73
(0.058)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | Analysis performed using a general linear model with treatment and center as factors. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0431 |
| Comments | Analysis was two-sided and performed at the 0.05 significance level. | |
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.15 | |
| Confidence Interval |
(2-Sided) 95% -0.29 to -0.00 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.073 |
|
| Estimation Comments | ||
| Title | Patient Global Impression of Change (PGIC) Score at Endpoint |
|---|---|
| Description | The PGIC was a participant-rated global measure that provided a clinically relevant and easy to interpret account of a participant's perception of the clinical importance of their own improvement or worsening during their involvement in a clinical study. Participants rated their overall improvement on a 7-point scale where scores ranged from 1 (very much improved) to 7 (very much worse). |
| Time Frame | Day 63 (Week 9)/Early Termination (Study Endpoint) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used. |
| Arm/Group Title | Pregabalin | Placebo |
|---|---|---|
| Arm/Group Description | Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day). | Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period. |
| Measure Participants | 297 | 290 |
| Least Squares Mean (Standard Error) [units on a scale] |
2.60
(0.057)
|
2.74
(0.058)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | Analysis performed using a general linear model with treatment and center as factors. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0602 |
| Comments | Analysis was two-sided and performed at the 0.05 significance level. | |
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.14 | |
| Confidence Interval |
(2-Sided) 95% -0.28 to 0.01 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.074 |
|
| Estimation Comments | ||
| Title | Baseline Hospital Anxiety and Depression Scale (HADS) Scores |
|---|---|
| Description | The HADS was a self-administered questionnaire that consisted of 2 subscales, 1 measuring anxiety (HADS-A Scale) and the other measuring depression (HADS-D Scale). Each subscale comprised of 7 items; participants assessed how each item applied to them on a scale of 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Subscores from HADS-A (Anxiety) and HADS-D (Depression) were not to be combined. The interpretation of each HADS subscales was as follows: 0-7 normal, 8-10 mild, 11-14 moderate and 15-21 severe. |
| Time Frame | Baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants in the FAS population, consisting of all participants randomized to treatment that received at least 1 dose of study medication. |
| Arm/Group Title | Pregabalin | Placebo |
|---|---|---|
| Arm/Group Description | Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day). | Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period. |
| Measure Participants | 313 | 307 |
| Anxiety total score |
3.76
(3.800)
|
3.67
(3.645)
|
| Depression total score |
4.45
(4.081)
|
4.35
(3.798)
|
| Title | Change From Baseline in HADS Anxiety Total Score at Endpoint |
|---|---|
| Description | The HADS was a self-administered questionnaire that consisted of 2 subscales, 1 measuring anxiety (HADS-A Scale) and the other measuring depression (HADS-D Scale). Each subscale was comprised of 7 items; participants assessed how each item applied to them on a scale of 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Subscores from HADS-A (Anxiety) and HADS-D (Depression) were not to be combined. The interpretation of each HADS subscales was as follows: 0-7 normal, 8-10 mild, 11-14 moderate and 15-21 severe. |
| Time Frame | Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used. |
| Arm/Group Title | Pregabalin | Placebo |
|---|---|---|
| Arm/Group Description | Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day). | Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period. |
| Measure Participants | 296 | 286 |
| Least Squares Mean (Standard Error) [units on a scale] |
-0.48
(0.161)
|
-0.31
(0.163)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4172 |
| Comments | Analysis was two-sided and performed at the 0.05 significance level. | |
| Method | ANCOVA | |
| Comments | The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model. | |
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.17 | |
| Confidence Interval |
(2-Sided) 95% -0.57 to 0.24 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.207 |
|
| Estimation Comments | ||
| Title | Change From Baseline in HADS Depression Total Score at Endpoint |
|---|---|
| Description | The HADS was a self-administered questionnaire that consisted of 2 subscales, 1 measuring anxiety (HADS-A Scale) and the other measuring depression (HADS-D Scale). Each subscale was comprised of 7 items; participants assessed how each item applied to them on a scale of 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Subscores from HADS-A (Anxiety) and HADS-D (Depression) were not to be combined. The interpretation of each HADS subscales was as follows: 0-7 normal, 8-10 mild, 11-14 moderate and 15-21 severe. |
| Time Frame | Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used. |
| Arm/Group Title | Pregabalin | Placebo |
|---|---|---|
| Arm/Group Description | Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day). | Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period. |
| Measure Participants | 297 | 286 |
| Least Squares Mean (Standard Error) [units on a scale] |
-0.57
(0.169)
|
-0.38
(0.172)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3724 |
| Comments | Analysis was two-sided and performed at the 0.05 significance level. | |
| Method | ANCOVA | |
| Comments | The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model. | |
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.19 | |
| Confidence Interval |
(2-Sided) 95% -0.62 to 0.23 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.218 |
|
| Estimation Comments | ||
Adverse Events
| Time Frame | From Baseline till Week 10 (Day 70) and/or Early Termination. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis. | |||
| Arm/Group Title | Pregabalin | Placebo | ||
| Arm/Group Description | Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day). | Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period. | ||
All Cause Mortality |
||||
| Pregabalin | Placebo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Pregabalin | Placebo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 7/314 (2.2%) | 5/308 (1.6%) | ||
| Cardiac disorders | ||||
| Cardiac failure | 1/314 (0.3%) | 0/308 (0%) | ||
| Eye disorders | ||||
| Cataract | 1/314 (0.3%) | 0/308 (0%) | ||
| Infections and infestations | ||||
| Gastroenteritis | 1/314 (0.3%) | 0/308 (0%) | ||
| Infection | 0/314 (0%) | 1/308 (0.3%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Spinal osteoarthritis | 0/314 (0%) | 1/308 (0.3%) | ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Glioma | 0/314 (0%) | 1/308 (0.3%) | ||
| Nervous system disorders | ||||
| Basal ganglia haemorrhage | 1/314 (0.3%) | 0/308 (0%) | ||
| Cerebral infarction | 1/314 (0.3%) | 2/308 (0.6%) | ||
| Diabetic neuropathy | 1/314 (0.3%) | 0/308 (0%) | ||
| Hypoglycaemic coma | 0/314 (0%) | 1/308 (0.3%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Interstitial lung disease | 1/314 (0.3%) | 0/308 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Pregabalin | Placebo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 77/314 (24.5%) | 55/308 (17.9%) | ||
| Eye disorders | ||||
| Vision blurred | 4/314 (1.3%) | 0/308 (0%) | ||
| Gastrointestinal disorders | ||||
| Diarrhoea | 6/314 (1.9%) | 7/308 (2.3%) | ||
| Nausea | 5/314 (1.6%) | 0/308 (0%) | ||
| General disorders | ||||
| Oedema peripheral | 10/314 (3.2%) | 1/308 (0.3%) | ||
| Hepatobiliary disorders | ||||
| Hepatic function abnormal | 4/314 (1.3%) | 0/308 (0%) | ||
| Infections and infestations | ||||
| Nasopharyngitis | 4/314 (1.3%) | 6/308 (1.9%) | ||
| Upper respiratory tract infection | 7/314 (2.2%) | 6/308 (1.9%) | ||
| Urinary tract infection | 7/314 (2.2%) | 12/308 (3.9%) | ||
| Metabolism and nutrition disorders | ||||
| Hyperuricaemia | 2/314 (0.6%) | 5/308 (1.6%) | ||
| Nervous system disorders | ||||
| Dizziness | 30/314 (9.6%) | 12/308 (3.9%) | ||
| Headache | 4/314 (1.3%) | 6/308 (1.9%) | ||
| Somnolence | 18/314 (5.7%) | 6/308 (1.9%) | ||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
| Name/Title | Pfizer ClinicalTrials.gov Call Center |
|---|---|
| Organization | Pfizer, Inc. |
| Phone | 1-800-718-1021 |
| ClinicalTrials.gov_Inquiries@pfizer.com |
Responsible Party:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
ClinicalTrials.gov Identifier:
NCT01332149
Other Study ID Numbers:
- A0081265
First Posted:
Apr 8, 2011
Last Update Posted:
Jan 28, 2021
Last Verified:
Jun 1, 2015