Trial Outcomes & Findings for Study To Evaluate Efficacy, Safety And Tolerability Of Lyrica In Patients With Painful Diabetic Peripheral Neuropathy (NCT NCT01332149)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

626 participants

Primary outcome timeframe

Baseline

Results posted on

2021-01-28

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Pregabalin 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).	Placebo 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.
Overall Study STARTED	314	309
Overall Study Treated	313	307
Overall Study COMPLETED	284	271
Overall Study NOT COMPLETED	30	38

Reasons for withdrawal

Reasons for withdrawal
Measure	Pregabalin 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).	Placebo 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.
Overall Study Adverse Event	11	9
Overall Study Other unspecified	5	7
Overall Study Protocol Violation	1	3
Overall Study Withdrawal by Subject	4	5
Overall Study Lost to Follow-up	1	1
Overall Study Insufficient clinical response	4	7
Overall Study Did not meet entrance criteria	3	4
Overall Study Randomized but not treated	1	2

Baseline Characteristics

Study To Evaluate Efficacy, Safety And Tolerability Of Lyrica In Patients With Painful Diabetic Peripheral Neuropathy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pregabalin n=313 Participants 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).	Placebo n=307 Participants 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 n=620 Participants Total of all reporting groups
Age, Customized 18-44 years	25 participants 10.3 • n=5 Participants	15 participants 9.5 • n=7 Participants	40 participants n=5 Participants
Age, Customized 45-64 years	172 participants n=5 Participants	178 participants n=7 Participants	350 participants n=5 Participants
Age, Customized More than or equal to (>=) 65 years	116 participants n=5 Participants	114 participants n=7 Participants	230 participants n=5 Participants
Sex: Female, Male Female	159 Participants n=5 Participants	168 Participants n=7 Participants	327 Participants n=5 Participants
Sex: Female, Male Male	154 Participants n=5 Participants	139 Participants n=7 Participants	293 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Pregabalin n=313 Participants 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).	Placebo n=307 Participants 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.
Baseline Mean Pain Score	6.65 units on a scale Standard Deviation 1.117	6.67 units on a scale Standard Deviation 1.150

PRIMARY outcome

Timeframe: Baseline and end of fixed dose phase (Day 63/Week 9)/Early Termination (Study Endpoint)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Pregabalin n=312 Participants 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).	Placebo n=307 Participants 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.
Change From Baseline in Mean Pain Score at Endpoint	-2.14 units on a scale Standard Error 0.115	-1.86 units on a scale Standard Error 0.117

SECONDARY outcome

Timeframe: Baseline and weekly from Weeks 1 to 9

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Pregabalin n=313 Participants 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).	Placebo n=307 Participants 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.
Change From Baseline in Weekly Mean Pain Score at Weeks 1 to 9 Week 1 change from baseline (N=312, 307)	-0.60 units on a scale Standard Error 0.091	-0.36 units on a scale Standard Error 0.092
Change From Baseline in Weekly Mean Pain Score at Weeks 1 to 9 Week 2 change from baseline (N=304, 295)	-0.97 units on a scale Standard Error 0.092	-0.71 units on a scale Standard Error 0.093
Change From Baseline in Weekly Mean Pain Score at Weeks 1 to 9 Week 3 change from baseline (N=298, 291)	-1.25 units on a scale Standard Error 0.092	-1.01 units on a scale Standard Error 0.093
Change From Baseline in Weekly Mean Pain Score at Weeks 1 to 9 Week 4 change from baseline (N=297, 289)	-1.47 units on a scale Standard Error 0.092	-1.21 units on a scale Standard Error 0.093
Change From Baseline in Weekly Mean Pain Score at Weeks 1 to 9 Week 5 change from baseline (N=296, 287)	-1.61 units on a scale Standard Error 0.092	-1.39 units on a scale Standard Error 0.093
Change From Baseline in Weekly Mean Pain Score at Weeks 1 to 9 Week 6 change from baseline (N=293, 278)	-1.84 units on a scale Standard Error 0.092	-1.59 units on a scale Standard Error 0.094
Change From Baseline in Weekly Mean Pain Score at Weeks 1 to 9 Week 7 change from baseline (N=290, 275)	-2.04 units on a scale Standard Error 0.092	-1.77 units on a scale Standard Error 0.094
Change From Baseline in Weekly Mean Pain Score at Weeks 1 to 9 Week 8 change from baseline (N=290, 275)	-2.18 units on a scale Standard Error 0.092	-1.88 units on a scale Standard Error 0.094
Change From Baseline in Weekly Mean Pain Score at Weeks 1 to 9 Week 9 change from baseline (N=287, 273)	-2.32 units on a scale Standard Error 0.092	-2.07 units on a scale Standard Error 0.094
Change From Baseline in Weekly Mean Pain Score at Weeks 1 to 9 Overall change from baseline	-1.59 units on a scale Standard Error 0.082	-1.33 units on a scale Standard Error 0.083

SECONDARY outcome

Timeframe: Baseline

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Pregabalin n=313 Participants 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).	Placebo n=307 Participants 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.
Baseline Mean Sleep Interference Score	5.25 units on a scale Standard Deviation 2.236	5.12 units on a scale Standard Deviation 2.278

SECONDARY outcome

Timeframe: Baseline and end of fixed dose phase (Day 63/Week 9)/Early Termination (Study Endpoint)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Pregabalin n=311 Participants 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).	Placebo n=307 Participants 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.
Change From Baseline in Mean Sleep Interference Score at Endpoint	-1.52 units on a scale Standard Error 0.110	-1.30 units on a scale Standard Error 0.112

SECONDARY outcome

Timeframe: Baseline and weekly from Weeks 1 to 9

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Pregabalin n=313 Participants 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).	Placebo n=307 Participants 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.
Change From Baseline in Weekly Mean Sleep Interference Score at Weeks 1 to 9 Week 6 change from baseline (N=292, 278)	-1.32 units on a scale Standard Error 0.098	-1.07 units on a scale Standard Error 0.099
Change From Baseline in Weekly Mean Sleep Interference Score at Weeks 1 to 9 Week 1 change from baseline (N=311, 307)	-0.38 units on a scale Standard Error 0.096	-0.26 units on a scale Standard Error 0.098
Change From Baseline in Weekly Mean Sleep Interference Score at Weeks 1 to 9 Week 2 change from baseline (N=303, 295)	-0.66 units on a scale Standard Error 0.097	-0.51 units on a scale Standard Error 0.098
Change From Baseline in Weekly Mean Sleep Interference Score at Weeks 1 to 9 Week 3 change from baseline (N=297, 291)	-0.88 units on a scale Standard Error 0.097	-0.72 units on a scale Standard Error 0.099
Change From Baseline in Weekly Mean Sleep Interference Score at Weeks 1 to 9 Week 4 change from baseline (N=296, 289)	-1.06 units on a scale Standard Error 0.097	-0.86 units on a scale Standard Error 0.099
Change From Baseline in Weekly Mean Sleep Interference Score at Weeks 1 to 9 Week 5 change from baseline (N=295, 287)	-1.14 units on a scale Standard Error 0.097	-0.98 units on a scale Standard Error 0.099
Change From Baseline in Weekly Mean Sleep Interference Score at Weeks 1 to 9 Week 7 change from baseline (N=289, 275)	-1.43 units on a scale Standard Error 0.098	-1.25 units on a scale Standard Error 0.099
Change From Baseline in Weekly Mean Sleep Interference Score at Weeks 1 to 9 Week 8 change from baseline (N=289, 275)	-1.59 units on a scale Standard Error 0.098	-1.36 units on a scale Standard Error 0.099
Change From Baseline in Weekly Mean Sleep Interference Score at Weeks 1 to 9 Week 9 change from baseline (N=286, 273)	-1.67 units on a scale Standard Error 0.098	-1.49 units on a scale Standard Error 0.100
Change From Baseline in Weekly Mean Sleep Interference Score at Weeks 1 to 9 Overall change from baseline	-1.13 units on a scale Standard Error 0.085	-0.94 units on a scale Standard Error 0.087

SECONDARY outcome

Timeframe: End of fixed dose phase (Day 63/Week 9)/Early Termination (Study Endpoint)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Pregabalin n=312 Participants 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).	Placebo n=307 Participants 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.
Percentage of 30 Percent (%) Responders at Endpoint	50.3 percentage of participants 0.115	44.3 percentage of participants 0.117

SECONDARY outcome

Timeframe: Baseline; Weeks 1, 5, and 9

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Pregabalin n=313 Participants 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).	Placebo n=307 Participants 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.
Change From Baseline in Short Form McGill Pain Questionnaire (SF-MPQ) Score at Weeks 1, 5, and 9 Sensory score, Baseline (N=313, 306)	7.90 units on a scale Standard Deviation 5.101	8.11 units on a scale Standard Deviation 5.098
Change From Baseline in Short Form McGill Pain Questionnaire (SF-MPQ) Score at Weeks 1, 5, and 9 Sensory score, Week 1 change (N=311, 304)	-1.50 units on a scale Standard Deviation 3.422	-1.34 units on a scale Standard Deviation 3.134
Change From Baseline in Short Form McGill Pain Questionnaire (SF-MPQ) Score at Weeks 1, 5, and 9 Sensory score, Week 5 change (N=297, 288)	-2.89 units on a scale Standard Deviation 4.244	-2.47 units on a scale Standard Deviation 3.925
Change From Baseline in Short Form McGill Pain Questionnaire (SF-MPQ) Score at Weeks 1, 5, and 9 Sensory score, Week 9 change (N=288, 274)	-3.87 units on a scale Standard Deviation 4.432	-3.37 units on a scale Standard Deviation 4.348
Change From Baseline in Short Form McGill Pain Questionnaire (SF-MPQ) Score at Weeks 1, 5, and 9 Affective score, Baseline (N=313, 307)	1.25 units on a scale Standard Deviation 1.809	1.20 units on a scale Standard Deviation 1.817
Change From Baseline in Short Form McGill Pain Questionnaire (SF-MPQ) Score at Weeks 1, 5, and 9 Affective score, Week 1 change (N=311, 304)	-0.41 units on a scale Standard Deviation 1.569	-0.37 units on a scale Standard Deviation 1.410
Change From Baseline in Short Form McGill Pain Questionnaire (SF-MPQ) Score at Weeks 1, 5, and 9 Affective score, Week 5 change (N=297, 289)	-0.72 units on a scale Standard Deviation 1.724	-0.62 units on a scale Standard Deviation 1.652
Change From Baseline in Short Form McGill Pain Questionnaire (SF-MPQ) Score at Weeks 1, 5, and 9 Affective score, Week 9 change (N=287, 274)	-0.75 units on a scale Standard Deviation 1.744	-0.62 units on a scale Standard Deviation 1.792
Change From Baseline in Short Form McGill Pain Questionnaire (SF-MPQ) Score at Weeks 1, 5, and 9 Total score, Baseline (N=313, 307)	9.15 units on a scale Standard Deviation 6.118	9.28 units on a scale Standard Deviation 6.445
Change From Baseline in Short Form McGill Pain Questionnaire (SF-MPQ) Score at Weeks 1, 5, and 9 Total score, Week 1 change (N=311, 305)	-1.92 units on a scale Standard Deviation 4.260	-1.70 units on a scale Standard Deviation 3.908
Change From Baseline in Short Form McGill Pain Questionnaire (SF-MPQ) Score at Weeks 1, 5, and 9 Total score, Week 5 change (N=297, 289)	-3.61 units on a scale Standard Deviation 5.084	-3.07 units on a scale Standard Deviation 4.893
Change From Baseline in Short Form McGill Pain Questionnaire (SF-MPQ) Score at Weeks 1, 5, and 9 Total score, Week 9 change (N=288, 274)	-4.62 units on a scale Standard Deviation 5.272	-4.00 units on a scale Standard Deviation 5.512

SECONDARY outcome

Timeframe: Baseline

Population: All participants in the FAS population, consisting of all participants randomized to treatment that received at least 1 dose of study medication.

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).

Outcome measures

Outcome measures
Measure	Pregabalin n=313 Participants 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).	Placebo n=307 Participants 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.
Baseline Pain Visual Analogue Scale (VAS) and Present Pain Intensity (PPI) Scale VAS	69.08 units on a scale Standard Deviation 11.474	69.06 units on a scale Standard Deviation 11.811
Baseline Pain Visual Analogue Scale (VAS) and Present Pain Intensity (PPI) Scale PPI	2.28 units on a scale Standard Deviation 0.784	2.27 units on a scale Standard Deviation 0.830

SECONDARY outcome

Timeframe: Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)

Population: 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.

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).

Outcome measures

Outcome measures
Measure	Pregabalin n=310 Participants 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).	Placebo n=304 Participants 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.
Change From Baseline in Pain VAS From the SF-MPQ at Endpoint	-25.07 units on a scale Standard Error 1.260	-21.82 units on a scale Standard Error 1.279

SECONDARY outcome

Timeframe: Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)

Population: 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.

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).

Outcome measures

Outcome measures
Measure	Pregabalin n=309 Participants 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).	Placebo n=305 Participants 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.
Change From Baseline in PPI Scale From the SF-MPQ at Endpoint	-0.80 units on a scale Standard Error 0.047	-0.73 units on a scale Standard Error 0.048

SECONDARY outcome

Timeframe: Baseline

Population: 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

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).

Outcome measures

Outcome measures
Measure	Pregabalin n=313 Participants 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).	Placebo n=307 Participants 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.
Baseline Medical Outcomes Study (MOS)-Sleep Scale Scores Sleep disturbance score (N=313, 307)	36.29 units on a scale Standard Deviation 24.768	35.13 units on a scale Standard Deviation 26.915
Baseline Medical Outcomes Study (MOS)-Sleep Scale Scores Snoring score (N=312, 307)	35.13 units on a scale Standard Deviation 36.670	37.59 units on a scale Standard Deviation 37.163
Baseline Medical Outcomes Study (MOS)-Sleep Scale Scores Awaken short of breath score (N=313, 307)	11.50 units on a scale Standard Deviation 21.557	10.75 units on a scale Standard Deviation 21.883
Baseline Medical Outcomes Study (MOS)-Sleep Scale Scores Quantity of sleep score (N=311, 304)	6.07 units on a scale Standard Deviation 2.882	5.98 units on a scale Standard Deviation 1.451
Baseline Medical Outcomes Study (MOS)-Sleep Scale Scores Sleep adequacy score (N=313, 307)	57.32 units on a scale Standard Deviation 31.518	60.88 units on a scale Standard Deviation 30.274
Baseline Medical Outcomes Study (MOS)-Sleep Scale Scores Somnolence score (N=312, 307)	33.87 units on a scale Standard Deviation 20.459	36.03 units on a scale Standard Deviation 21.491
Baseline Medical Outcomes Study (MOS)-Sleep Scale Scores Sleep problems index score (N=312, 307)	32.19 units on a scale Standard Deviation 19.806	31.21 units on a scale Standard Deviation 20.388

SECONDARY outcome

Timeframe: Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Pregabalin n=297 Participants 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).	Placebo n=286 Participants 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.
Change From Baseline in MOS-Sleep Scale, Sleep Disturbance Score at Endpoint	-9.11 units on a scale Standard Error 1.222	-7.98 units on a scale Standard Error 1.244

SECONDARY outcome

Timeframe: Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Pregabalin n=295 Participants 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).	Placebo n=285 Participants 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.
Change From Baseline in MOS-Sleep Scale, Snoring Score at Endpoint	2.78 units on a scale Standard Error 1.716	-0.53 units on a scale Standard Error 1.743

SECONDARY outcome

Timeframe: Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Pregabalin n=295 Participants 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).	Placebo n=286 Participants 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.
Change From Baseline in MOS-Sleep Scale, Awaken Short of Breath Score at Endpoint	-2.10 units on a scale Standard Error 1.061	-2.31 units on a scale Standard Error 1.078

SECONDARY outcome

Timeframe: Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)

Population: 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.

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).

Outcome measures

Outcome measures
Measure	Pregabalin n=295 Participants 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).	Placebo n=280 Participants 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.
Change From Baseline in MOS-Sleep Scale, Quantity of Sleep Score at Endpoint	0.33 units on a scale Standard Error 0.085	0.14 units on a scale Standard Error 0.087

SECONDARY outcome

Timeframe: Day 63 (Week 9)/Early Termination (Study Endpoint)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Pregabalin n=297 Participants 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).	Placebo n=282 Participants 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.
Percentage of Participants Who Had Optimal Sleep at Endpoint	43.8 percentage of participants 0.085	45.0 percentage of participants 0.087

SECONDARY outcome

Timeframe: Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Pregabalin n=297 Participants 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).	Placebo n=285 Participants 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.
Change From Baseline in MOS-Sleep Scale, Sleep Adequacy Score at Endpoint	8.87 units on a scale Standard Error 1.532	7.82 units on a scale Standard Error 1.552

SECONDARY outcome

Timeframe: Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Pregabalin n=295 Participants 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).	Placebo n=285 Participants 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.
Change From Baseline in MOS-Sleep Scale, Somnolence Score at Endpoint	-1.22 units on a scale Standard Error 1.187	-0.88 units on a scale Standard Error 1.208

SECONDARY outcome

Timeframe: Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Pregabalin n=294 Participants 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).	Placebo n=284 Participants 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.
Change From Baseline in MOS-Sleep Scale, Sleep Problems Index Score at Endpoint	-6.71 units on a scale Standard Error 0.914	-5.88 units on a scale Standard Error 0.927

SECONDARY outcome

Timeframe: Day 63 (Week 9)/Early Termination (Study Endpoint)

Population: 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.

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).

Outcome measures

Outcome measures
Measure	Pregabalin n=299 Participants 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).	Placebo n=290 Participants 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.
Clinical Global Impression of Change (CGIC) at Endpoint	2.58 units on a scale Standard Error 0.057	2.73 units on a scale Standard Error 0.058

SECONDARY outcome

Timeframe: Day 63 (Week 9)/Early Termination (Study Endpoint)

Population: 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.

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).

Outcome measures

Outcome measures
Measure	Pregabalin n=297 Participants 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).	Placebo n=290 Participants 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.
Patient Global Impression of Change (PGIC) Score at Endpoint	2.60 units on a scale Standard Error 0.057	2.74 units on a scale Standard Error 0.058

SECONDARY outcome

Timeframe: Baseline

Population: All participants in the FAS population, consisting of all participants randomized to treatment that received at least 1 dose of study medication.

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.

Outcome measures

Outcome measures
Measure	Pregabalin n=313 Participants 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).	Placebo n=307 Participants 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.
Baseline Hospital Anxiety and Depression Scale (HADS) Scores Anxiety total score	3.76 units on a scale Standard Deviation 3.800	3.67 units on a scale Standard Deviation 3.645
Baseline Hospital Anxiety and Depression Scale (HADS) Scores Depression total score	4.45 units on a scale Standard Deviation 4.081	4.35 units on a scale Standard Deviation 3.798

SECONDARY outcome

Timeframe: Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Pregabalin n=296 Participants 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).	Placebo n=286 Participants 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.
Change From Baseline in HADS Anxiety Total Score at Endpoint	-0.48 units on a scale Standard Error 0.161	-0.31 units on a scale Standard Error 0.163

SECONDARY outcome

Timeframe: Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Pregabalin n=297 Participants 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).	Placebo n=286 Participants 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.
Change From Baseline in HADS Depression Total Score at Endpoint	-0.57 units on a scale Standard Error 0.169	-0.38 units on a scale Standard Error 0.172

Adverse Events

Pregabalin

Serious events: 7 serious events

Other events: 77 other events

Deaths: 0 deaths

Placebo

Serious events: 5 serious events

Other events: 55 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Pregabalin n=314 participants at risk 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).	Placebo n=308 participants at risk 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.
Cardiac disorders Cardiac failure	0.32% 1/314 • From Baseline till Week 10 (Day 70) and/or Early Termination. 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.	0.00% 0/308 • From Baseline till Week 10 (Day 70) and/or Early Termination. 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.
Eye disorders Cataract	0.32% 1/314 • From Baseline till Week 10 (Day 70) and/or Early Termination. 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.	0.00% 0/308 • From Baseline till Week 10 (Day 70) and/or Early Termination. 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.
Infections and infestations Gastroenteritis	0.32% 1/314 • From Baseline till Week 10 (Day 70) and/or Early Termination. 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.	0.00% 0/308 • From Baseline till Week 10 (Day 70) and/or Early Termination. 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.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.00% 0/314 • From Baseline till Week 10 (Day 70) and/or Early Termination. 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.	0.32% 1/308 • From Baseline till Week 10 (Day 70) and/or Early Termination. 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.
Infections and infestations Infection	0.00% 0/314 • From Baseline till Week 10 (Day 70) and/or Early Termination. 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.	0.32% 1/308 • From Baseline till Week 10 (Day 70) and/or Early Termination. 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioma	0.00% 0/314 • From Baseline till Week 10 (Day 70) and/or Early Termination. 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.	0.32% 1/308 • From Baseline till Week 10 (Day 70) and/or Early Termination. 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.
Nervous system disorders Basal ganglia haemorrhage	0.32% 1/314 • From Baseline till Week 10 (Day 70) and/or Early Termination. 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.	0.00% 0/308 • From Baseline till Week 10 (Day 70) and/or Early Termination. 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.
Nervous system disorders Cerebral infarction	0.32% 1/314 • From Baseline till Week 10 (Day 70) and/or Early Termination. 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.	0.65% 2/308 • From Baseline till Week 10 (Day 70) and/or Early Termination. 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.
Nervous system disorders Diabetic neuropathy	0.32% 1/314 • From Baseline till Week 10 (Day 70) and/or Early Termination. 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.	0.00% 0/308 • From Baseline till Week 10 (Day 70) and/or Early Termination. 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.
Nervous system disorders Hypoglycaemic coma	0.00% 0/314 • From Baseline till Week 10 (Day 70) and/or Early Termination. 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.	0.32% 1/308 • From Baseline till Week 10 (Day 70) and/or Early Termination. 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.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.32% 1/314 • From Baseline till Week 10 (Day 70) and/or Early Termination. 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.	0.00% 0/308 • From Baseline till Week 10 (Day 70) and/or Early Termination. 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.

Other adverse events

Other adverse events
Measure	Pregabalin n=314 participants at risk 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).	Placebo n=308 participants at risk 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.
Eye disorders Vision blurred	1.3% 4/314 • From Baseline till Week 10 (Day 70) and/or Early Termination. 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.	0.00% 0/308 • From Baseline till Week 10 (Day 70) and/or Early Termination. 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.
Gastrointestinal disorders Diarrhoea	1.9% 6/314 • From Baseline till Week 10 (Day 70) and/or Early Termination. 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.	2.3% 7/308 • From Baseline till Week 10 (Day 70) and/or Early Termination. 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.
Gastrointestinal disorders Nausea	1.6% 5/314 • From Baseline till Week 10 (Day 70) and/or Early Termination. 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.	0.00% 0/308 • From Baseline till Week 10 (Day 70) and/or Early Termination. 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.
General disorders Oedema peripheral	3.2% 10/314 • From Baseline till Week 10 (Day 70) and/or Early Termination. 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.	0.32% 1/308 • From Baseline till Week 10 (Day 70) and/or Early Termination. 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.
Hepatobiliary disorders Hepatic function abnormal	1.3% 4/314 • From Baseline till Week 10 (Day 70) and/or Early Termination. 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.	0.00% 0/308 • From Baseline till Week 10 (Day 70) and/or Early Termination. 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.
Infections and infestations Nasopharyngitis	1.3% 4/314 • From Baseline till Week 10 (Day 70) and/or Early Termination. 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.	1.9% 6/308 • From Baseline till Week 10 (Day 70) and/or Early Termination. 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.
Infections and infestations Upper respiratory tract infection	2.2% 7/314 • From Baseline till Week 10 (Day 70) and/or Early Termination. 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.	1.9% 6/308 • From Baseline till Week 10 (Day 70) and/or Early Termination. 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.
Infections and infestations Urinary tract infection	2.2% 7/314 • From Baseline till Week 10 (Day 70) and/or Early Termination. 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.	3.9% 12/308 • From Baseline till Week 10 (Day 70) and/or Early Termination. 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.
Metabolism and nutrition disorders Hyperuricaemia	0.64% 2/314 • From Baseline till Week 10 (Day 70) and/or Early Termination. 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.	1.6% 5/308 • From Baseline till Week 10 (Day 70) and/or Early Termination. 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.
Nervous system disorders Dizziness	9.6% 30/314 • From Baseline till Week 10 (Day 70) and/or Early Termination. 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.	3.9% 12/308 • From Baseline till Week 10 (Day 70) and/or Early Termination. 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.
Nervous system disorders Headache	1.3% 4/314 • From Baseline till Week 10 (Day 70) and/or Early Termination. 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.	1.9% 6/308 • From Baseline till Week 10 (Day 70) and/or Early Termination. 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.
Nervous system disorders Somnolence	5.7% 18/314 • From Baseline till Week 10 (Day 70) and/or Early Termination. 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.	1.9% 6/308 • From Baseline till Week 10 (Day 70) and/or Early Termination. 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.

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