Trial Outcomes & Findings for A 13-Week, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study Of Pregabalin For Postherpetic Neuralgia (NCT NCT00394901)
NCT ID: NCT00394901
Last Updated: 2021-02-09
Results Overview
Endpoint mean pain score is defined as the mean of the last 7 daily pain diary rating while taking the study medication, up to and including day after last dose. Scores range from 0-10 (11 points ordinal) with higher scores indicating increased pain.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
372 participants
Primary outcome timeframe
Week13/discontinuation
Results posted on
2021-02-09
Participant Flow
Fifty (50) centers in Japan
After a 1-week baseline phase, subjects were stratified into 1 of 2 strata based on their creatinine clearance (CLcr) values (Low, 30 \<CLcr \<=60 mL/min or Normal, CLcr \> 60 mL/min) and then equally randomized into 1 of 4 treatment groups.
Participant milestones
| Measure |
Placebo
During a 13-week double-blind phase, subjects received matching placebo.
|
Pregabalin 150 mg/Day
During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
|
Pregabalin 300 mg/Day
During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
|
Pregabalin 600 mg/Day
During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
|
|---|---|---|---|---|
|
Baseline Phase
STARTED
|
98
|
87
|
90
|
97
|
|
Baseline Phase
COMPLETED
|
98
|
87
|
89
|
97
|
|
Baseline Phase
NOT COMPLETED
|
0
|
0
|
1
|
0
|
|
Double-blind Phase
STARTED
|
98
|
87
|
89
|
97
|
|
Double-blind Phase
COMPLETED
|
83
|
73
|
71
|
70
|
|
Double-blind Phase
NOT COMPLETED
|
15
|
14
|
18
|
27
|
Reasons for withdrawal
| Measure |
Placebo
During a 13-week double-blind phase, subjects received matching placebo.
|
Pregabalin 150 mg/Day
During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
|
Pregabalin 300 mg/Day
During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
|
Pregabalin 600 mg/Day
During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
|
|---|---|---|---|---|
|
Baseline Phase
Protocol Violation
|
0
|
0
|
1
|
0
|
|
Double-blind Phase
Adverse Event
|
5
|
7
|
16
|
20
|
|
Double-blind Phase
Lack of Efficacy
|
6
|
4
|
1
|
3
|
|
Double-blind Phase
Withdrawal by Subject
|
2
|
0
|
0
|
0
|
|
Double-blind Phase
Lost to Follow-up
|
0
|
0
|
0
|
1
|
|
Double-blind Phase
Protocol Violation
|
0
|
0
|
0
|
1
|
|
Double-blind Phase
Death
|
1
|
0
|
0
|
0
|
|
Double-blind Phase
Subject's Personal Reason
|
1
|
0
|
0
|
1
|
|
Double-blind Phase
Lack of Compliance
|
0
|
3
|
0
|
0
|
|
Double-blind Phase
Entry into another study was found
|
0
|
0
|
1
|
0
|
|
Double-blind Phase
Found not to meet entrance criteria
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A 13-Week, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study Of Pregabalin For Postherpetic Neuralgia
Baseline characteristics by cohort
| Measure |
Placebo
n=98 Participants
During a 13-week double-blind phase, subjects received matching placebo.
|
Pregabalin 150 mg/Day
n=87 Participants
During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
|
Pregabalin 300 mg/Day
n=89 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
|
Pregabalin 600 mg/Day
n=97 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
|
Total
n=371 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
71.1 years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
70.2 years
STANDARD_DEVIATION 9.2 • n=7 Participants
|
70.9 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
68.4 years
STANDARD_DEVIATION 12.5 • n=4 Participants
|
70.1 years
STANDARD_DEVIATION 10.2 • n=21 Participants
|
|
Age, Customized
<18 years
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
|
Age, Customized
Between 18 and 44 years
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
6 participants
n=4 Participants
|
11 participants
n=21 Participants
|
|
Age, Customized
Between 45 and 64 years
|
12 participants
n=5 Participants
|
17 participants
n=7 Participants
|
15 participants
n=5 Participants
|
20 participants
n=4 Participants
|
64 participants
n=21 Participants
|
|
Age, Customized
>=65 years
|
84 participants
n=5 Participants
|
69 participants
n=7 Participants
|
72 participants
n=5 Participants
|
71 participants
n=4 Participants
|
296 participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
173 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
57 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
198 Participants
n=21 Participants
|
|
Region of Enrollment
Japan
|
98 participants
n=5 Participants
|
87 participants
n=7 Participants
|
89 participants
n=5 Participants
|
97 participants
n=4 Participants
|
371 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Week13/discontinuationPopulation: Full analysis set. Last observation carried forward.
Endpoint mean pain score is defined as the mean of the last 7 daily pain diary rating while taking the study medication, up to and including day after last dose. Scores range from 0-10 (11 points ordinal) with higher scores indicating increased pain.
Outcome measures
| Measure |
Placebo
n=97 Participants
During a 13-week double-blind phase, subjects received matching placebo.
|
Pregabalin 150 mg/Day
n=86 Participants
During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
|
Pregabalin 300 mg/Day
n=89 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
|
Pregabalin 600 mg/Day
n=97 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
|
|---|---|---|---|---|
|
Mean Pain Scores at Endpoint
|
5.12 score on scale
Standard Error 0.19
|
4.81 score on scale
Standard Error 0.20
|
4.26 score on scale
Standard Error 0.20
|
4.49 score on scale
Standard Error 0.19
|
PRIMARY outcome
Timeframe: Week13/discontinuationPopulation: Full analysis set. Last observation carried forward.
Endpoint mean pain score is defined as the mean of the last 7 daily pain diary rating while taking the study medication, up to and including day after last dose. Scores range from 0-10 (11 points ordinal) with higher scores indicating increased pain.
Outcome measures
| Measure |
Placebo
n=97 Participants
During a 13-week double-blind phase, subjects received matching placebo.
|
Pregabalin 150 mg/Day
n=92 Participants
During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
|
Pregabalin 300 mg/Day
n=122 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
|
Pregabalin 600 mg/Day
During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
|
|---|---|---|---|---|
|
Mean Pain Score at Endpoint by Groups of Subjects With Expected Similar Plasma Concentrations
|
4.99 score on scale
Standard Error 0.18
|
4.35 score on scale
Standard Error 0.19
|
4.34 score on scale
Standard Error 0.16
|
—
|
PRIMARY outcome
Timeframe: Week13/discontinuationPopulation: Full analysis set. Last observation carried forward.
A responder is defined as a subject with a 50% reduction in weekly mean pain score from baseline to endpoint.
Outcome measures
| Measure |
Placebo
n=97 Participants
During a 13-week double-blind phase, subjects received matching placebo.
|
Pregabalin 150 mg/Day
n=86 Participants
During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
|
Pregabalin 300 mg/Day
n=89 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
|
Pregabalin 600 mg/Day
n=97 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
|
|---|---|---|---|---|
|
Number of Responders
|
15 participants
|
21 participants
|
32 participants
|
30 participants
|
PRIMARY outcome
Timeframe: Week 1Population: Full analysis set. Observed case.
Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.
Outcome measures
| Measure |
Placebo
n=97 Participants
During a 13-week double-blind phase, subjects received matching placebo.
|
Pregabalin 150 mg/Day
n=86 Participants
During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
|
Pregabalin 300 mg/Day
n=89 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
|
Pregabalin 600 mg/Day
n=97 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
|
|---|---|---|---|---|
|
Mean Pain Scores at Week 1
|
5.96 score on scale
Standard Error 0.17
|
5.45 score on scale
Standard Error 0.18
|
5.21 score on scale
Standard Error 0.18
|
5.23 score on scale
Standard Error 0.17
|
PRIMARY outcome
Timeframe: Week 2Population: Full analysis set. Observed case.
Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.
Outcome measures
| Measure |
Placebo
n=96 Participants
During a 13-week double-blind phase, subjects received matching placebo.
|
Pregabalin 150 mg/Day
n=83 Participants
During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
|
Pregabalin 300 mg/Day
n=83 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
|
Pregabalin 600 mg/Day
n=86 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
|
|---|---|---|---|---|
|
Mean Pain Scores at Week 2
|
5.75 score on scale
Standard Error 0.17
|
5.27 score on scale
Standard Error 0.18
|
4.76 score on scale
Standard Error 0.18
|
4.73 score on scale
Standard Error 0.17
|
PRIMARY outcome
Timeframe: Week 3Population: Full analysis set. Observed case.
Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.
Outcome measures
| Measure |
Placebo
n=92 Participants
During a 13-week double-blind phase, subjects received matching placebo.
|
Pregabalin 150 mg/Day
n=83 Participants
During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
|
Pregabalin 300 mg/Day
n=80 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
|
Pregabalin 600 mg/Day
n=84 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
|
|---|---|---|---|---|
|
Mean Pain Scores at Week 3
|
5.59 score on scale
Standard Error 0.17
|
5.18 score on scale
Standard Error 0.18
|
4.63 score on scale
Standard Error 0.18
|
4.60 score on scale
Standard Error 0.17
|
PRIMARY outcome
Timeframe: Week4Population: Full analysis set. Observed case.
Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.
Outcome measures
| Measure |
Placebo
n=92 Participants
During a 13-week double-blind phase, subjects received matching placebo.
|
Pregabalin 150 mg/Day
n=82 Participants
During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
|
Pregabalin 300 mg/Day
n=78 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
|
Pregabalin 600 mg/Day
n=82 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
|
|---|---|---|---|---|
|
Mean Pain Scores at Week 4
|
5.43 score on scale
Standard Error 0.17
|
5.14 score on scale
Standard Error 0.18
|
4.57 score on scale
Standard Error 0.18
|
4.50 score on scale
Standard Error 0.17
|
PRIMARY outcome
Timeframe: Week 5Population: Full analysis set. Observed case.
Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.
Outcome measures
| Measure |
Placebo
n=90 Participants
During a 13-week double-blind phase, subjects received matching placebo.
|
Pregabalin 150 mg/Day
n=81 Participants
During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
|
Pregabalin 300 mg/Day
n=77 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
|
Pregabalin 600 mg/Day
n=78 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
|
|---|---|---|---|---|
|
Mean Pain Scores at Week 5
|
5.29 score on scale
Standard Error 0.17
|
5.15 score on scale
Standard Error 0.18
|
4.42 score on scale
Standard Error 0.18
|
4.55 score on scale
Standard Error 0.18
|
PRIMARY outcome
Timeframe: Week 6Population: Full analysis set. Observed case.
Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.
Outcome measures
| Measure |
Placebo
n=89 Participants
During a 13-week double-blind phase, subjects received matching placebo.
|
Pregabalin 150 mg/Day
n=80 Participants
During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
|
Pregabalin 300 mg/Day
n=77 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
|
Pregabalin 600 mg/Day
n=78 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
|
|---|---|---|---|---|
|
Mean Pain Scores at Week 6
|
5.29 score on scale
Standard Error 0.17
|
5.02 score on scale
Standard Error 0.18
|
4.31 score on scale
Standard Error 0.18
|
4.54 score on scale
Standard Error 0.18
|
PRIMARY outcome
Timeframe: Week 7Population: Full analysis set. Observed case.
Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.
Outcome measures
| Measure |
Placebo
n=88 Participants
During a 13-week double-blind phase, subjects received matching placebo.
|
Pregabalin 150 mg/Day
n=80 Participants
During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
|
Pregabalin 300 mg/Day
n=75 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
|
Pregabalin 600 mg/Day
n=78 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
|
|---|---|---|---|---|
|
Mean Pain Scores at Week 7
|
5.14 score on scale
Standard Error 0.17
|
4.90 score on scale
Standard Error 0.18
|
4.24 score on scale
Standard Error 0.18
|
4.48 score on scale
Standard Error 0.18
|
PRIMARY outcome
Timeframe: Week 8Population: Full analysis set. Observed case.
Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.
Outcome measures
| Measure |
Placebo
n=88 Participants
During a 13-week double-blind phase, subjects received matching placebo.
|
Pregabalin 150 mg/Day
n=79 Participants
During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
|
Pregabalin 300 mg/Day
n=75 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
|
Pregabalin 600 mg/Day
n=76 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
|
|---|---|---|---|---|
|
Mean Pain Scores at Week 8
|
5.04 score on scale
Standard Error 0.17
|
4.89 score on scale
Standard Error 0.18
|
4.23 score on scale
Standard Error 0.18
|
4.47 score on scale
Standard Error 0.18
|
PRIMARY outcome
Timeframe: Week 9Population: Full analysis set. Observed case.
Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.
Outcome measures
| Measure |
Placebo
n=86 Participants
During a 13-week double-blind phase, subjects received matching placebo.
|
Pregabalin 150 mg/Day
n=78 Participants
During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
|
Pregabalin 300 mg/Day
n=73 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
|
Pregabalin 600 mg/Day
n=74 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
|
|---|---|---|---|---|
|
Mean Pain Scores at Week 9
|
5.08 score on scale
Standard Error 0.17
|
4.87 score on scale
Standard Error 0.18
|
4.22 score on scale
Standard Error 0.18
|
4.50 score on scale
Standard Error 0.18
|
PRIMARY outcome
Timeframe: Week 10Population: Full analysis set. Observed case.
Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.
Outcome measures
| Measure |
Placebo
n=86 Participants
During a 13-week double-blind phase, subjects received matching placebo.
|
Pregabalin 150 mg/Day
n=77 Participants
During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
|
Pregabalin 300 mg/Day
n=72 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
|
Pregabalin 600 mg/Day
n=72 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
|
|---|---|---|---|---|
|
Mean Pain Scores at Week 10
|
5.08 score on scale
Standard Error 0.17
|
4.86 score on scale
Standard Error 0.18
|
4.18 score on scale
Standard Error 0.18
|
4.56 score on scale
Standard Error 0.18
|
PRIMARY outcome
Timeframe: Week 11Population: Full analysis set. Observed case.
Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.
Outcome measures
| Measure |
Placebo
n=85 Participants
During a 13-week double-blind phase, subjects received matching placebo.
|
Pregabalin 150 mg/Day
n=75 Participants
During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
|
Pregabalin 300 mg/Day
n=72 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
|
Pregabalin 600 mg/Day
n=71 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
|
|---|---|---|---|---|
|
Mean Pain Scores at Week 11
|
5.12 score on scale
Standard Error 0.17
|
4.88 score on scale
Standard Error 0.18
|
4.18 score on scale
Standard Error 0.18
|
4.47 score on scale
Standard Error 0.18
|
PRIMARY outcome
Timeframe: Week 12Population: Full analysis set. Observed case.
Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.
Outcome measures
| Measure |
Placebo
n=83 Participants
During a 13-week double-blind phase, subjects received matching placebo.
|
Pregabalin 150 mg/Day
n=74 Participants
During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
|
Pregabalin 300 mg/Day
n=72 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
|
Pregabalin 600 mg/Day
n=71 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
|
|---|---|---|---|---|
|
Mean Pain Scores at Week 12
|
5.00 score on scale
Standard Error 0.17
|
4.71 score on scale
Standard Error 0.18
|
4.15 score on scale
Standard Error 0.18
|
4.37 score on scale
Standard Error 0.18
|
PRIMARY outcome
Timeframe: Week 13Population: Full analysis set. Observed case.
Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.
Outcome measures
| Measure |
Placebo
n=82 Participants
During a 13-week double-blind phase, subjects received matching placebo.
|
Pregabalin 150 mg/Day
n=73 Participants
During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
|
Pregabalin 300 mg/Day
n=72 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
|
Pregabalin 600 mg/Day
n=71 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
|
|---|---|---|---|---|
|
Mean Pain Scores at Week 13
|
4.97 score on scale
Standard Error 0.17
|
4.70 score on scale
Standard Error 0.18
|
4.16 score on scale
Standard Error 0.18
|
4.36 score on scale
Standard Error 0.18
|
SECONDARY outcome
Timeframe: Week13/discontinuationPopulation: Full analysis set. Last observation carried forward.
Sensory score range from 0-33. Higher scores indicate more severe pain.
Outcome measures
| Measure |
Placebo
n=97 Participants
During a 13-week double-blind phase, subjects received matching placebo.
|
Pregabalin 150 mg/Day
n=86 Participants
During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
|
Pregabalin 300 mg/Day
n=89 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
|
Pregabalin 600 mg/Day
n=97 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
|
|---|---|---|---|---|
|
Endpoint Sensory Scores of the Short-Form McGill Pain Questionnaire
|
8.97 score on scale
Standard Error 0.57
|
8.42 score on scale
Standard Error 0.61
|
7.11 score on scale
Standard Error 0.60
|
6.97 score on scale
Standard Error 0.57
|
SECONDARY outcome
Timeframe: Week13/discontinuationPopulation: Full analysis set. Last observation carried forward.
Affective score range from 0-12. Higher scores indicate more severe pain.
Outcome measures
| Measure |
Placebo
n=97 Participants
During a 13-week double-blind phase, subjects received matching placebo.
|
Pregabalin 150 mg/Day
n=86 Participants
During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
|
Pregabalin 300 mg/Day
n=88 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
|
Pregabalin 600 mg/Day
n=97 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
|
|---|---|---|---|---|
|
Endpoint Affective Scores of the Short-Form McGill Pain Questionnaire
|
2.43 score on scale
Standard Error 0.22
|
2.14 score on scale
Standard Error 0.23
|
1.72 score on scale
Standard Error 0.23
|
1.82 score on scale
Standard Error 0.22
|
SECONDARY outcome
Timeframe: Week13/discontinuationPopulation: Full analysis set. Last observation carried forward
Total score range from 0-45. Higher scores indicate more severe pain.
Outcome measures
| Measure |
Placebo
n=97 Participants
During a 13-week double-blind phase, subjects received matching placebo.
|
Pregabalin 150 mg/Day
n=86 Participants
During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
|
Pregabalin 300 mg/Day
n=89 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
|
Pregabalin 600 mg/Day
n=97 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
|
|---|---|---|---|---|
|
Endpoint Total Scores of the Short-Form McGill Pain Questionnaire
|
11.39 score on scale
Standard Error 0.75
|
10.56 score on scale
Standard Error 0.79
|
8.84 score on scale
Standard Error 0.79
|
8.78 score on scale
Standard Error 0.75
|
SECONDARY outcome
Timeframe: Week13/discontinuationPopulation: Full analysis set. Last observation carried forward.
Visual Analogue Scale Score range from 0-100mm. Higher scores indicate more severe pain.
Outcome measures
| Measure |
Placebo
n=97 Participants
During a 13-week double-blind phase, subjects received matching placebo.
|
Pregabalin 150 mg/Day
n=86 Participants
During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
|
Pregabalin 300 mg/Day
n=89 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
|
Pregabalin 600 mg/Day
n=97 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
|
|---|---|---|---|---|
|
Endpoint Visual Analogue Scale Scores of the Short-Form McGill Pain Questionnaire
|
50.02 mm
Standard Error 2.15
|
47.80 mm
Standard Error 2.28
|
41.99 mm
Standard Error 2.25
|
42.59 mm
Standard Error 2.14
|
SECONDARY outcome
Timeframe: Week13/discontinuationPopulation: Full analysis set. Last observation carried forward.
Present pain intensity score range from 0-5. Higher scores indicate more severe pain.
Outcome measures
| Measure |
Placebo
n=97 Participants
During a 13-week double-blind phase, subjects received matching placebo.
|
Pregabalin 150 mg/Day
n=86 Participants
During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
|
Pregabalin 300 mg/Day
n=89 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
|
Pregabalin 600 mg/Day
n=96 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
|
|---|---|---|---|---|
|
Endpoint Present Pain Intensity Scores of the Short-Form McGill Pain Questionnaire
|
2.21 score on scale
Standard Error 0.10
|
2.01 score on scale
Standard Error 0.11
|
1.78 score on scale
Standard Error 0.11
|
1.90 score on scale
Standard Error 0.10
|
SECONDARY outcome
Timeframe: Week13/discontinuationPopulation: Full analysis set. Last observation carried forward.
Scores range from 0-10. Higher scores indicate more severe interference with sleep.
Outcome measures
| Measure |
Placebo
n=97 Participants
During a 13-week double-blind phase, subjects received matching placebo.
|
Pregabalin 150 mg/Day
n=86 Participants
During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
|
Pregabalin 300 mg/Day
n=89 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
|
Pregabalin 600 mg/Day
n=97 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
|
|---|---|---|---|---|
|
Mean Sleep Interference Scores at Endpoint
|
3.20 score on scale
Standard Error 0.17
|
2.44 score on scale
Standard Error 0.18
|
2.39 score on scale
Standard Error 0.17
|
2.26 score on scale
Standard Error 0.17
|
SECONDARY outcome
Timeframe: Week13/discontinuationPopulation: Full analysis set. Last observation carried forward.
Score range for sleep disturbance is 0-100.Higher scores indicate more of the attribute.
Outcome measures
| Measure |
Placebo
n=95 Participants
During a 13-week double-blind phase, subjects received matching placebo.
|
Pregabalin 150 mg/Day
n=82 Participants
During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
|
Pregabalin 300 mg/Day
n=86 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
|
Pregabalin 600 mg/Day
n=93 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
|
|---|---|---|---|---|
|
Endpoint Medical Outcomes Study Sleep Scale Scores:Sleep Disturbance
|
31.99 score on scale
Standard Error 1.88
|
23.09 score on scale
Standard Error 2.00
|
23.75 score on scale
Standard Error 1.99
|
20.65 score on scale
Standard Error 1.88
|
SECONDARY outcome
Timeframe: Week13/discontinuationPopulation: Full analysis set. Last observation carried forward.
Score range for snoring is 0-100.Higher scores indicate more of the attribute.
Outcome measures
| Measure |
Placebo
n=95 Participants
During a 13-week double-blind phase, subjects received matching placebo.
|
Pregabalin 150 mg/Day
n=82 Participants
During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
|
Pregabalin 300 mg/Day
n=87 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
|
Pregabalin 600 mg/Day
n=93 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
|
|---|---|---|---|---|
|
Endpoint Medical Outcomes Study Sleep Scale Scores:Snoring
|
22.28 score on scale
Standard Error 2.57
|
26.58 score on scale
Standard Error 2.74
|
25.24 score on scale
Standard Error 2.73
|
31.99 score on scale
Standard Error 2.59
|
SECONDARY outcome
Timeframe: Week13/discontinuationPopulation: Full analysis set. Last observation carried forward.
Score range for awaken short of breath or with headache is 0-100. Higher scores indicate more of the attribute.
Outcome measures
| Measure |
Placebo
n=95 Participants
During a 13-week double-blind phase, subjects received matching placebo.
|
Pregabalin 150 mg/Day
n=82 Participants
During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
|
Pregabalin 300 mg/Day
n=87 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
|
Pregabalin 600 mg/Day
n=93 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
|
|---|---|---|---|---|
|
Endpoint Medical Outcomes Study Sleep Scale Scores:Awaken Short of Breath or With Headache
|
5.99 score on scale
Standard Error 1.61
|
6.70 score on scale
Standard Error 1.72
|
6.70 score on scale
Standard Error 1.69
|
4.95 score on scale
Standard Error 1.62
|
SECONDARY outcome
Timeframe: Week13/discontinuationPopulation: Full analysis set. Last observation carried forward.
Sleep Quantity subscale is scored from 0-24 indicating the number of hours of sleep. Higher scores indicate more of the attribute named in the subscale.
Outcome measures
| Measure |
Placebo
n=95 Participants
During a 13-week double-blind phase, subjects received matching placebo.
|
Pregabalin 150 mg/Day
n=82 Participants
During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
|
Pregabalin 300 mg/Day
n=87 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
|
Pregabalin 600 mg/Day
n=93 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
|
|---|---|---|---|---|
|
Endpoint Medical Outcomes Study Sleep Scale Scores:Quantity of Sleep
|
6.58 score on scale
Standard Error 0.11
|
6.59 score on scale
Standard Error 0.12
|
6.85 score on scale
Standard Error 0.12
|
6.79 score on scale
Standard Error 0.11
|
SECONDARY outcome
Timeframe: Week13/discontinuationPopulation: Full analysis set. Last observation carried forward.
Score range for sleep adequacy is 0-100. Higher scores indicate more of the attribute.
Outcome measures
| Measure |
Placebo
n=95 Participants
During a 13-week double-blind phase, subjects received matching placebo.
|
Pregabalin 150 mg/Day
n=82 Participants
During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
|
Pregabalin 300 mg/Day
n=87 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
|
Pregabalin 600 mg/Day
n=93 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
|
|---|---|---|---|---|
|
Endpoint Medical Outcomes Study Sleep Scale Scores:Sleep Adequacy
|
63.37 score on scale
Standard Error 2.67
|
67.38 score on scale
Standard Error 2.85
|
73.67 score on scale
Standard Error 2.82
|
69.37 score on scale
Standard Error 2.69
|
SECONDARY outcome
Timeframe: Week13/discontinuationPopulation: Full analysis set. Last observation carried forward.
Score range for Somnolence is 0-100. Higher scores indicate more of the attribute.
Outcome measures
| Measure |
Placebo
n=95 Participants
During a 13-week double-blind phase, subjects received matching placebo.
|
Pregabalin 150 mg/Day
n=82 Participants
During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
|
Pregabalin 300 mg/Day
n=87 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
|
Pregabalin 600 mg/Day
n=93 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
|
|---|---|---|---|---|
|
Endpoint Medical Outcomes Study Sleep Scale Scores:Somnolence
|
30.23 score on scale
Standard Error 2.09
|
34.16 score on scale
Standard Error 2.23
|
41.45 score on scale
Standard Error 2.19
|
44.46 score on scale
Standard Error 2.10
|
SECONDARY outcome
Timeframe: Week13/discontinuationPopulation: Full analysis set. Last observation carried forward.
Score range for overall sleep problem index is 0-100. Higher scores indicate more of the attribute.
Outcome measures
| Measure |
Placebo
n=95 Participants
During a 13-week double-blind phase, subjects received matching placebo.
|
Pregabalin 150 mg/Day
n=82 Participants
During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
|
Pregabalin 300 mg/Day
n=86 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
|
Pregabalin 600 mg/Day
n=93 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
|
|---|---|---|---|---|
|
Endpoint Medical Outcomes Study Sleep Scale Scores:Overall Sleep Problem Index
|
29.22 score on scale
Standard Error 1.50
|
25.19 score on scale
Standard Error 1.59
|
26.03 score on scale
Standard Error 1.58
|
26.78 score on scale
Standard Error 1.50
|
SECONDARY outcome
Timeframe: Week13/discontinuationPopulation: Full analysis set. Last observation carried forward.
Number of participants who reported Optimal Sleep
Outcome measures
| Measure |
Placebo
n=95 Participants
During a 13-week double-blind phase, subjects received matching placebo.
|
Pregabalin 150 mg/Day
n=82 Participants
During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
|
Pregabalin 300 mg/Day
n=87 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
|
Pregabalin 600 mg/Day
n=93 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
|
|---|---|---|---|---|
|
Endpoint Medical Outcomes Study Sleep Scale: Number of Participants With Optimal Sleep
|
37 participants
|
26 participants
|
48 participants
|
44 participants
|
SECONDARY outcome
Timeframe: Week13/discontinuationPopulation: Full analysis set. Last observation carried forward.
Patient Global Impression Change is scaled from 1 to 7. 1=very much improved, 7=very much worse.
Outcome measures
| Measure |
Placebo
n=95 Participants
During a 13-week double-blind phase, subjects received matching placebo.
|
Pregabalin 150 mg/Day
n=82 Participants
During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
|
Pregabalin 300 mg/Day
n=87 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
|
Pregabalin 600 mg/Day
n=93 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
|
|---|---|---|---|---|
|
Endpoint Patient Global Impression Change
|
3.6 score on scale
Standard Deviation 1.2
|
3.3 score on scale
Standard Deviation 1.2
|
2.9 score on scale
Standard Deviation 1.0
|
3.0 score on scale
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: Week13/discontinuationPopulation: Full analysis set. Last observation carried forward.
Clinical Global Impression Change is scaled from 1 to 7. 1=very much improved, 7=very much worse.
Outcome measures
| Measure |
Placebo
n=95 Participants
During a 13-week double-blind phase, subjects received matching placebo.
|
Pregabalin 150 mg/Day
n=83 Participants
During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
|
Pregabalin 300 mg/Day
n=87 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
|
Pregabalin 600 mg/Day
n=93 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
|
|---|---|---|---|---|
|
Endpoint Clinical Global Impression Change
|
3.3 score on scale
Standard Deviation 1.1
|
3.1 score on scale
Standard Deviation 1.2
|
2.7 score on scale
Standard Deviation 1.1
|
2.7 score on scale
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: Week13/discontinuationPopulation: Full analysis set. Last observation carried forward.
Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.
Outcome measures
| Measure |
Placebo
n=95 Participants
During a 13-week double-blind phase, subjects received matching placebo.
|
Pregabalin 150 mg/Day
n=82 Participants
During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
|
Pregabalin 300 mg/Day
n=87 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
|
Pregabalin 600 mg/Day
n=93 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
|
|---|---|---|---|---|
|
Endpoint Short-Form 36-Item Health Survey Scores: Physical Functioning
|
76.16 score on scale
Standard Error 1.28
|
79.68 score on scale
Standard Error 1.37
|
76.93 score on scale
Standard Error 1.34
|
77.20 score on scale
Standard Error 1.28
|
SECONDARY outcome
Timeframe: Week13/discontinuationPopulation: Full analysis set. Last observation carried forward.
Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.
Outcome measures
| Measure |
Placebo
n=95 Participants
During a 13-week double-blind phase, subjects received matching placebo.
|
Pregabalin 150 mg/Day
n=82 Participants
During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
|
Pregabalin 300 mg/Day
n=87 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
|
Pregabalin 600 mg/Day
n=93 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
|
|---|---|---|---|---|
|
Endpoint Short-Form 36-Item Health Survey Scores: Role Limitations-Physical
|
67.96 score on scale
Standard Error 2.26
|
77.35 score on scale
Standard Error 2.41
|
74.63 score on scale
Standard Error 2.38
|
69.42 score on scale
Standard Error 2.28
|
SECONDARY outcome
Timeframe: Week13/discontinuationPopulation: Full analysis set. Last observation carried forward.
Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.
Outcome measures
| Measure |
Placebo
n=95 Participants
During a 13-week double-blind phase, subjects received matching placebo.
|
Pregabalin 150 mg/Day
n=82 Participants
During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
|
Pregabalin 300 mg/Day
n=87 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
|
Pregabalin 600 mg/Day
n=93 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
|
|---|---|---|---|---|
|
Endpoint Short-Form 36-Item Health Survey Scores: Bodily Pain
|
47.47 score on scale
Standard Error 1.82
|
48.09 score on scale
Standard Error 1.94
|
54.54 score on scale
Standard Error 1.91
|
52.50 score on scale
Standard Error 1.83
|
SECONDARY outcome
Timeframe: Week13/discontinuationPopulation: Full analysis set. Last observation carried forward.
Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.
Outcome measures
| Measure |
Placebo
n=95 Participants
During a 13-week double-blind phase, subjects received matching placebo.
|
Pregabalin 150 mg/Day
n=82 Participants
During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
|
Pregabalin 300 mg/Day
n=87 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
|
Pregabalin 600 mg/Day
n=93 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
|
|---|---|---|---|---|
|
Endpoint Short-Form 36-Item Health Survey Scores: General Health Perception
|
52.36 score on scale
Standard Error 1.49
|
57.66 score on scale
Standard Error 1.59
|
56.19 score on scale
Standard Error 1.57
|
56.30 score on scale
Standard Error 1.50
|
SECONDARY outcome
Timeframe: Week13/discontinuationPopulation: Full analysis set. Last observation carried forward.
Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.
Outcome measures
| Measure |
Placebo
n=95 Participants
During a 13-week double-blind phase, subjects received matching placebo.
|
Pregabalin 150 mg/Day
n=82 Participants
During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
|
Pregabalin 300 mg/Day
n=87 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
|
Pregabalin 600 mg/Day
n=93 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
|
|---|---|---|---|---|
|
Endpoint Short-Form 36-Item Health Survey Scores: Social Functioning
|
75.28 score on scale
Standard Error 2.20
|
77.71 score on scale
Standard Error 2.35
|
82.69 score on scale
Standard Error 2.32
|
77.11 score on scale
Standard Error 2.22
|
SECONDARY outcome
Timeframe: Week13/discontinuationPopulation: Full analysis set. Last observation carried forward.
Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.
Outcome measures
| Measure |
Placebo
n=95 Participants
During a 13-week double-blind phase, subjects received matching placebo.
|
Pregabalin 150 mg/Day
n=82 Participants
During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
|
Pregabalin 300 mg/Day
n=87 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
|
Pregabalin 600 mg/Day
n=93 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
|
|---|---|---|---|---|
|
Endpoint Short-Form 36-Item Health Survey Scores: Role Limitations-Emotional
|
69.99 score on scale
Standard Error 2.40
|
76.14 score on scale
Standard Error 2.56
|
75.41 score on scale
Standard Error 2.52
|
73.02 score on scale
Standard Error 2.41
|
SECONDARY outcome
Timeframe: Week13/discontinuationPopulation: Full analysis set. Last observation carried forward.
Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.
Outcome measures
| Measure |
Placebo
n=95 Participants
During a 13-week double-blind phase, subjects received matching placebo.
|
Pregabalin 150 mg/Day
n=82 Participants
During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
|
Pregabalin 300 mg/Day
n=87 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
|
Pregabalin 600 mg/Day
n=93 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
|
|---|---|---|---|---|
|
Endpoint Short-Form 36-Item Health Survey Scores: Vitality
|
54.16 score on scale
Standard Error 1.90
|
59.80 score on scale
Standard Error 2.02
|
61.58 score on scale
Standard Error 2.00
|
58.31 score on scale
Standard Error 1.91
|
SECONDARY outcome
Timeframe: Week13/discontinuationPopulation: Full analysis set. Last observation carried forward.
Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.
Outcome measures
| Measure |
Placebo
n=95 Participants
During a 13-week double-blind phase, subjects received matching placebo.
|
Pregabalin 150 mg/Day
n=82 Participants
During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
|
Pregabalin 300 mg/Day
n=87 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
|
Pregabalin 600 mg/Day
n=93 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
|
|---|---|---|---|---|
|
Endpoint Short-Form 36-Item Health Survey Scores: Mental Health
|
61.91 score on scale
Standard Error 1.95
|
65.90 score on scale
Standard Error 2.08
|
68.90 score on scale
Standard Error 2.05
|
66.67 score on scale
Standard Error 1.96
|
SECONDARY outcome
Timeframe: Week13/discontinuationPopulation: Full analysis set. Last observation carried forward.
Participants not reporting allodynia.
Outcome measures
| Measure |
Placebo
n=95 Participants
During a 13-week double-blind phase, subjects received matching placebo.
|
Pregabalin 150 mg/Day
n=82 Participants
During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
|
Pregabalin 300 mg/Day
n=87 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
|
Pregabalin 600 mg/Day
n=93 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
|
|---|---|---|---|---|
|
Number of Patients Not Reporting Allodynia
|
65 participants
|
52 participants
|
63 participants
|
66 participants
|
SECONDARY outcome
Timeframe: Week13/discontinuationPopulation: Full analysis set. Last observation carried forward.
Participants not reporting hyperalgesia.
Outcome measures
| Measure |
Placebo
n=95 Participants
During a 13-week double-blind phase, subjects received matching placebo.
|
Pregabalin 150 mg/Day
n=82 Participants
During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
|
Pregabalin 300 mg/Day
n=87 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
|
Pregabalin 600 mg/Day
n=93 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
|
|---|---|---|---|---|
|
Number of Patients Not Reporting Hyperalgesia
|
66 participants
|
55 participants
|
66 participants
|
65 participants
|
SECONDARY outcome
Timeframe: week 1Population: Full analysis set. Observed case.
Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.
Outcome measures
| Measure |
Placebo
n=97 Participants
During a 13-week double-blind phase, subjects received matching placebo.
|
Pregabalin 150 mg/Day
n=86 Participants
During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
|
Pregabalin 300 mg/Day
n=89 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
|
Pregabalin 600 mg/Day
n=97 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
|
|---|---|---|---|---|
|
Mean Sleep Interference Scores at Week 1
|
3.79 score on scale
Standard Error 0.15
|
3.00 score on scale
Standard Error 0.16
|
2.97 score on scale
Standard Error 0.16
|
2.81 score on scale
Standard Error 0.15
|
SECONDARY outcome
Timeframe: week 2Population: Full analysis set. Observed case.
Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.
Outcome measures
| Measure |
Placebo
n=96 Participants
During a 13-week double-blind phase, subjects received matching placebo.
|
Pregabalin 150 mg/Day
n=83 Participants
During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
|
Pregabalin 300 mg/Day
n=83 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
|
Pregabalin 600 mg/Day
n=86 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
|
|---|---|---|---|---|
|
Mean Sleep Interference Scores at Week 2
|
3.56 score on scale
Standard Error 0.15
|
2.89 score on scale
Standard Error 0.16
|
2.76 score on scale
Standard Error 0.16
|
2.49 score on scale
Standard Error 0.15
|
SECONDARY outcome
Timeframe: week 3Population: Full analysis set. Observed case.
Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.
Outcome measures
| Measure |
Placebo
n=92 Participants
During a 13-week double-blind phase, subjects received matching placebo.
|
Pregabalin 150 mg/Day
n=83 Participants
During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
|
Pregabalin 300 mg/Day
n=80 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
|
Pregabalin 600 mg/Day
n=84 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
|
|---|---|---|---|---|
|
Mean Sleep Interference Scores at Week 3
|
3.50 score on scale
Standard Error 0.15
|
2.81 score on scale
Standard Error 0.16
|
2.60 score on scale
Standard Error 0.16
|
2.43 score on scale
Standard Error 0.15
|
SECONDARY outcome
Timeframe: week 4Population: Full analysis set. Observed case.
Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.
Outcome measures
| Measure |
Placebo
n=92 Participants
During a 13-week double-blind phase, subjects received matching placebo.
|
Pregabalin 150 mg/Day
n=82 Participants
During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
|
Pregabalin 300 mg/Day
n=78 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
|
Pregabalin 600 mg/Day
n=82 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
|
|---|---|---|---|---|
|
Mean Sleep Interference Scores at Week 4
|
3.35 score on scale
Standard Error 0.15
|
2.79 score on scale
Standard Error 0.16
|
2.54 score on scale
Standard Error 0.16
|
2.36 score on scale
Standard Error 0.15
|
SECONDARY outcome
Timeframe: week 5Population: Full analysis set. Observed case.
Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.
Outcome measures
| Measure |
Placebo
n=90 Participants
During a 13-week double-blind phase, subjects received matching placebo.
|
Pregabalin 150 mg/Day
n=81 Participants
During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
|
Pregabalin 300 mg/Day
n=77 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
|
Pregabalin 600 mg/Day
n=78 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
|
|---|---|---|---|---|
|
Mean Sleep Interference Scores at Week 5
|
3.26 score on scale
Standard Error 0.15
|
2.74 score on scale
Standard Error 0.16
|
2.39 score on scale
Standard Error 0.16
|
2.41 score on scale
Standard Error 0.15
|
SECONDARY outcome
Timeframe: week 6Population: Full analysis set. Observed case.
Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.
Outcome measures
| Measure |
Placebo
n=89 Participants
During a 13-week double-blind phase, subjects received matching placebo.
|
Pregabalin 150 mg/Day
n=80 Participants
During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
|
Pregabalin 300 mg/Day
n=77 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
|
Pregabalin 600 mg/Day
n=78 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
|
|---|---|---|---|---|
|
Mean Sleep Interference Scores at Week 6
|
3.24 score on scale
Standard Error 0.15
|
2.63 score on scale
Standard Error 0.16
|
2.37 score on scale
Standard Error 0.16
|
2.33 score on scale
Standard Error 0.15
|
SECONDARY outcome
Timeframe: week 7Population: Full analysis set. Observed case.
Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.
Outcome measures
| Measure |
Placebo
n=88 Participants
During a 13-week double-blind phase, subjects received matching placebo.
|
Pregabalin 150 mg/Day
n=80 Participants
During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
|
Pregabalin 300 mg/Day
n=75 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
|
Pregabalin 600 mg/Day
n=78 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
|
|---|---|---|---|---|
|
Mean Sleep Interference Scores at Week 7
|
3.19 score on scale
Standard Error 0.15
|
2.55 score on scale
Standard Error 0.16
|
2.36 score on scale
Standard Error 0.16
|
2.21 score on scale
Standard Error 0.15
|
SECONDARY outcome
Timeframe: week 8Population: Full analysis set. Observed case.
Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.
Outcome measures
| Measure |
Placebo
n=88 Participants
During a 13-week double-blind phase, subjects received matching placebo.
|
Pregabalin 150 mg/Day
n=79 Participants
During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
|
Pregabalin 300 mg/Day
n=75 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
|
Pregabalin 600 mg/Day
n=76 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
|
|---|---|---|---|---|
|
Mean Sleep Interference Scores at Week 8
|
3.10 score on scale
Standard Error 0.15
|
2.49 score on scale
Standard Error 0.16
|
2.30 score on scale
Standard Error 0.16
|
2.14 score on scale
Standard Error 0.15
|
SECONDARY outcome
Timeframe: week 9Population: Full analysis set. Observed case.
Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.
Outcome measures
| Measure |
Placebo
n=86 Participants
During a 13-week double-blind phase, subjects received matching placebo.
|
Pregabalin 150 mg/Day
n=78 Participants
During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
|
Pregabalin 300 mg/Day
n=73 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
|
Pregabalin 600 mg/Day
n=74 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
|
|---|---|---|---|---|
|
Mean Sleep Interference Scores at Week 9
|
3.17 score on scale
Standard Error 0.15
|
2.44 score on scale
Standard Error 0.16
|
2.38 score on scale
Standard Error 0.16
|
2.22 score on scale
Standard Error 0.16
|
SECONDARY outcome
Timeframe: week 10Population: Full analysis set. Observed case.
Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.
Outcome measures
| Measure |
Placebo
n=86 Participants
During a 13-week double-blind phase, subjects received matching placebo.
|
Pregabalin 150 mg/Day
n=77 Participants
During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
|
Pregabalin 300 mg/Day
n=72 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
|
Pregabalin 600 mg/Day
n=72 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
|
|---|---|---|---|---|
|
Mean Sleep Interference Scores at Week 10
|
3.16 score on scale
Standard Error 0.15
|
2.46 score on scale
Standard Error 0.16
|
2.39 score on scale
Standard Error 0.16
|
2.28 score on scale
Standard Error 0.16
|
SECONDARY outcome
Timeframe: week 11Population: Full analysis set. Observed case.
Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.
Outcome measures
| Measure |
Placebo
n=85 Participants
During a 13-week double-blind phase, subjects received matching placebo.
|
Pregabalin 150 mg/Day
n=75 Participants
During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
|
Pregabalin 300 mg/Day
n=72 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
|
Pregabalin 600 mg/Day
n=71 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
|
|---|---|---|---|---|
|
Mean Sleep Interference Scores at Week 11
|
3.16 score on scale
Standard Error 0.15
|
2.43 score on scale
Standard Error 0.16
|
2.37 score on scale
Standard Error 0.16
|
2.27 score on scale
Standard Error 0.16
|
SECONDARY outcome
Timeframe: week 12Population: Full analysis set. Observed case.
Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.
Outcome measures
| Measure |
Placebo
n=83 Participants
During a 13-week double-blind phase, subjects received matching placebo.
|
Pregabalin 150 mg/Day
n=74 Participants
During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
|
Pregabalin 300 mg/Day
n=72 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
|
Pregabalin 600 mg/Day
n=71 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
|
|---|---|---|---|---|
|
Mean Sleep Interference Scores at Week 12
|
3.06 score on scale
Standard Error 0.15
|
2.36 score on scale
Standard Error 0.16
|
2.28 score on scale
Standard Error 0.16
|
2.21 score on scale
Standard Error 0.16
|
SECONDARY outcome
Timeframe: week 13Population: Full analysis set. Observed case.
Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.
Outcome measures
| Measure |
Placebo
n=82 Participants
During a 13-week double-blind phase, subjects received matching placebo.
|
Pregabalin 150 mg/Day
n=73 Participants
During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
|
Pregabalin 300 mg/Day
n=72 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
|
Pregabalin 600 mg/Day
n=71 Participants
During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
|
|---|---|---|---|---|
|
Mean Sleep Interference Scores at Week 13
|
3.08 score on scale
Standard Error 0.15
|
2.33 score on scale
Standard Error 0.16
|
2.27 score on scale
Standard Error 0.16
|
2.19 score on scale
Standard Error 0.16
|
Adverse Events
Placebo
Serious events: 6 serious events
Other events: 35 other events
Deaths: 0 deaths
Pregabalin 150 mg/Day
Serious events: 2 serious events
Other events: 44 other events
Deaths: 0 deaths
Pregabalin 300 mg/Day
Serious events: 4 serious events
Other events: 61 other events
Deaths: 0 deaths
Pregabalin 600 mg/Day
Serious events: 1 serious events
Other events: 77 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=98 participants at risk
During a 13-week double-blind phase, subjects received matching placebo.
|
Pregabalin 150 mg/Day
n=87 participants at risk
During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
|
Pregabalin 300 mg/Day
n=89 participants at risk
During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
|
Pregabalin 600 mg/Day
n=97 participants at risk
During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
|
|---|---|---|---|---|
|
Cardiac disorders
Angina pectoris
|
1.0%
1/98
|
0.00%
0/87
|
0.00%
0/89
|
0.00%
0/97
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/98
|
1.1%
1/87
|
0.00%
0/89
|
0.00%
0/97
|
|
Gastrointestinal disorders
Large intestinal stricture
|
0.00%
0/98
|
0.00%
0/87
|
0.00%
0/89
|
1.0%
1/97
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/98
|
1.1%
1/87
|
0.00%
0/89
|
0.00%
0/97
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
1.0%
1/98
|
0.00%
0/87
|
1.1%
1/89
|
0.00%
0/97
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/98
|
0.00%
0/87
|
1.1%
1/89
|
0.00%
0/97
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
1.0%
1/98
|
0.00%
0/87
|
0.00%
0/89
|
0.00%
0/97
|
|
Nervous system disorders
Cerebral infarction
|
1.0%
1/98
|
0.00%
0/87
|
0.00%
0/89
|
0.00%
0/97
|
|
Nervous system disorders
Loss of consciousness
|
1.0%
1/98
|
0.00%
0/87
|
1.1%
1/89
|
0.00%
0/97
|
|
Psychiatric disorders
Completed suicide
|
1.0%
1/98
|
0.00%
0/87
|
0.00%
0/89
|
0.00%
0/97
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/98
|
0.00%
0/87
|
1.1%
1/89
|
0.00%
0/97
|
|
Vascular disorders
Hypotension
|
0.00%
0/98
|
0.00%
0/87
|
1.1%
1/89
|
0.00%
0/97
|
Other adverse events
| Measure |
Placebo
n=98 participants at risk
During a 13-week double-blind phase, subjects received matching placebo.
|
Pregabalin 150 mg/Day
n=87 participants at risk
During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
|
Pregabalin 300 mg/Day
n=89 participants at risk
During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
|
Pregabalin 600 mg/Day
n=97 participants at risk
During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
|
|---|---|---|---|---|
|
Eye disorders
Diplopia
|
0.00%
0/98
|
0.00%
0/87
|
2.2%
2/89
|
6.2%
6/97
|
|
Gastrointestinal disorders
Constipation
|
6.1%
6/98
|
13.8%
12/87
|
12.4%
11/89
|
14.4%
14/97
|
|
Gastrointestinal disorders
Nausea
|
5.1%
5/98
|
2.3%
2/87
|
6.7%
6/89
|
7.2%
7/97
|
|
General disorders
Face oedema
|
0.00%
0/98
|
4.6%
4/87
|
1.1%
1/89
|
6.2%
6/97
|
|
General disorders
Oedema peripheral
|
1.0%
1/98
|
4.6%
4/87
|
13.5%
12/89
|
18.6%
18/97
|
|
General disorders
Thirst
|
3.1%
3/98
|
3.4%
3/87
|
7.9%
7/89
|
7.2%
7/97
|
|
Infections and infestations
Nasopharyngitis
|
10.2%
10/98
|
9.2%
8/87
|
11.2%
10/89
|
5.2%
5/97
|
|
Injury, poisoning and procedural complications
Contusion
|
2.0%
2/98
|
5.7%
5/87
|
4.5%
4/89
|
3.1%
3/97
|
|
Injury, poisoning and procedural complications
Fall
|
4.1%
4/98
|
6.9%
6/87
|
7.9%
7/89
|
4.1%
4/97
|
|
Investigations
Weight increased
|
0.00%
0/98
|
1.1%
1/87
|
19.1%
17/89
|
14.4%
14/97
|
|
Nervous system disorders
Dizziness
|
7.1%
7/98
|
11.5%
10/87
|
30.3%
27/89
|
49.5%
48/97
|
|
Nervous system disorders
Headache
|
1.0%
1/98
|
2.3%
2/87
|
1.1%
1/89
|
5.2%
5/97
|
|
Nervous system disorders
Somnolence
|
9.2%
9/98
|
21.8%
19/87
|
24.7%
22/89
|
38.1%
37/97
|
|
Skin and subcutaneous tissue disorders
Eczema
|
2.0%
2/98
|
3.4%
3/87
|
0.00%
0/89
|
6.2%
6/97
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of \<60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), \<12 mo from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential info other than study results.
- Publication restrictions are in place
Restriction type: OTHER