Trial Outcomes & Findings for A Study For Pregabalin In Patients With Fibromyalgia (NCT NCT01387607)

NCT ID: NCT01387607

Last Updated: 2021-01-28

Results Overview

Assessment of mean pain score was based on participant's daily pain diary. The daily pain diary consisted of an 11-point numeric rating scale ranging from 0 (no pain) to 10 (worst possible pain). The participants rated their pain during the past 24 hours by choosing the appropriate number between 0 and 10. Self-assessment was performed daily at awakening. The endpoint mean pain score was defined as the mean of the Week 14 pain diary entries in the double-blind treatment phase. Baseline was defined as the mean of last 7 pain diary entries up to and including Day 1.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 343 participants
• Primary outcome timeframe: Baseline, Week 14
• Results posted on: 2021-01-28

Participant Flow

A total of 431 participants were screened and 343 of these were randomized. A total of 334 participants received the assigned study treatment.

Participant milestones

Measure	Pregabalin Pregabalin was administered orally, at a dose level of 75 mg (1 capsule) twice daily (BID) (Day 0 evening - Day 7 morning) and 150 mg (1 capsule) BID (Day 7 evening - Day 14 morning) in the titration phase. Pregabalin was then administered at a dose level of 150 mg (1 capsule) BID or 225 mg (2 capsules; 75 mg + 150 mg) BID in Day 14 evening and Weeks 3 - 14 during the fixed-dose phase. A 1-week taper off dose phase was in the following with pregabalin 150 mg or 225 mg administered in the morning and 75 mg administered in the evening.	Placebo Placebo matched to pregabalin 75 mg (1 capsule) was administered twice daily (BID) (Day 0 evening - Day 7 morning) and 150 mg (1 capsule) BID (Day 7 evening - Day 14 morning) in the titration phase. Placebo was then administered as matched to pregabalin 150 mg (1 capsule) BID or 225 mg (2 capsules; 75 mg + 150 mg) BID in Day 14 evening and Weeks 3 - 14 during the fixed-dose phase. A 1-week taper off dose phase was in the following with placebo matched to pregabalin 150 mg or 225 mg administered in the morning and 75 mg administered in the evening. Number of capsules taken daily with placebo matched the number taken for the assigned pregabalin dose level.
Overall Study STARTED	173	170
Overall Study Received Treatment	170	164
Overall Study COMPLETED	122	125
Overall Study NOT COMPLETED	51	45

Reasons for withdrawal

Measure	Pregabalin Pregabalin was administered orally, at a dose level of 75 mg (1 capsule) twice daily (BID) (Day 0 evening - Day 7 morning) and 150 mg (1 capsule) BID (Day 7 evening - Day 14 morning) in the titration phase. Pregabalin was then administered at a dose level of 150 mg (1 capsule) BID or 225 mg (2 capsules; 75 mg + 150 mg) BID in Day 14 evening and Weeks 3 - 14 during the fixed-dose phase. A 1-week taper off dose phase was in the following with pregabalin 150 mg or 225 mg administered in the morning and 75 mg administered in the evening.	Placebo Placebo matched to pregabalin 75 mg (1 capsule) was administered twice daily (BID) (Day 0 evening - Day 7 morning) and 150 mg (1 capsule) BID (Day 7 evening - Day 14 morning) in the titration phase. Placebo was then administered as matched to pregabalin 150 mg (1 capsule) BID or 225 mg (2 capsules; 75 mg + 150 mg) BID in Day 14 evening and Weeks 3 - 14 during the fixed-dose phase. A 1-week taper off dose phase was in the following with placebo matched to pregabalin 150 mg or 225 mg administered in the morning and 75 mg administered in the evening. Number of capsules taken daily with placebo matched the number taken for the assigned pregabalin dose level.
Overall Study Adverse Event	23	11
Overall Study Lack of Efficacy	8	6
Overall Study Lost to Follow-up	2	1
Overall Study No longer meets eligibility criteria	0	1
Overall Study Protocol Violation	1	5
Overall Study Withdrawal by Subject	13	14
Overall Study Other	1	1
Overall Study Randomized, not treated	3	6

Baseline Characteristics

A Study For Pregabalin In Patients With Fibromyalgia

Baseline characteristics by cohort

Measure	Pregabalin n=170 Participants Pregabalin was administered orally, at a dose level of 75 mg (1 capsule) twice daily (BID) (Day 0 evening - Day 7 morning) and 150 mg (1 capsule) BID (Day 7 evening - Day 14 morning) in the titration phase. Pregabalin was then administered at a dose level of 150 mg (1 capsule) BID or 225 mg (2 capsules; 75 mg + 150 mg) BID in Day 14 evening and Weeks 3 - 14 during the fixed-dose phase. A 1-week taper off dose phase was in the following with pregabalin 150 mg or 225 mg administered in the morning and 75 mg administered in the evening.	Placebo n=164 Participants Placebo matched to pregabalin 75 mg (1 capsule) was administered twice daily (BID) (Day 0 evening - Day 7 morning) and 150 mg (1 capsule) BID (Day 7 evening - Day 14 morning) in the titration phase. Placebo was then administered as matched to pregabalin 150 mg (1 capsule) BID or 225 mg (2 capsules; 75 mg + 150 mg) BID in Day 14 evening and Weeks 3 - 14 during the fixed-dose phase. A 1-week taper off dose phase was in the following with placebo matched to pregabalin 150 mg or 225 mg administered in the morning and 75 mg administered in the evening. Number of capsules taken daily with placebo matched the number taken for the assigned pregabalin dose level.	Total n=334 Participants Total of all reporting groups
Age, Continuous	44.5 years STANDARD_DEVIATION 11.5 • n=5 Participants	43.5 years STANDARD_DEVIATION 10.6 • n=7 Participants	44.0 years STANDARD_DEVIATION 11.1 • n=5 Participants
Sex: Female, Male Female	142 Participants n=5 Participants	144 Participants n=7 Participants	286 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants	20 Participants n=7 Participants	48 Participants n=5 Participants
Primary Diagnoses and Durations Fibromyalgia duration since onset of symptoms	6.0 years STANDARD_DEVIATION 7.0 • n=5 Participants	5.6 years STANDARD_DEVIATION 6.4 • n=7 Participants	5.8 years STANDARD_DEVIATION 6.7 • n=5 Participants
Primary Diagnoses and Durations Fibromyalgia duration since diagnosis	0.3 years STANDARD_DEVIATION 1.0 • n=5 Participants	0.4 years STANDARD_DEVIATION 1.2 • n=7 Participants	0.3 years STANDARD_DEVIATION 1.1 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Week 14

Population: The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication.

Assessment of mean pain score was based on participant's daily pain diary. The daily pain diary consisted of an 11-point numeric rating scale ranging from 0 (no pain) to 10 (worst possible pain). The participants rated their pain during the past 24 hours by choosing the appropriate number between 0 and 10. Self-assessment was performed daily at awakening. The endpoint mean pain score was defined as the mean of the Week 14 pain diary entries in the double-blind treatment phase. Baseline was defined as the mean of last 7 pain diary entries up to and including Day 1.

Outcome measures

Measure	Pregabalin n=128 Participants Pregabalin was administered orally, at a dose level of 75 mg (1 capsule) twice daily (BID) (Day 0 evening - Day 7 morning) and 150 mg (1 capsule) BID (Day 7 evening - Day 14 morning) in the titration phase. Pregabalin was then administered at a dose level of 150 mg (1 capsule) BID or 225 mg (2 capsules; 75 mg + 150 mg) BID in Day 14 evening and Weeks 3 - 14 during the fixed-dose phase. A 1-week taper off dose phase was in the following with pregabalin 150 mg or 225 mg administered in the morning and 75 mg administered in the evening.	Placebo n=124 Participants Placebo matched to pregabalin 75 mg (1 capsule) was administered twice daily (BID) (Day 0 evening - Day 7 morning) and 150 mg (1 capsule) BID (Day 7 evening - Day 14 morning) in the titration phase. Placebo was then administered as matched to pregabalin 150 mg (1 capsule) BID or 225 mg (2 capsules; 75 mg + 150 mg) BID in Day 14 evening and Weeks 3 - 14 during the fixed-dose phase. A 1-week taper off dose phase was in the following with placebo matched to pregabalin 150 mg or 225 mg administered in the morning and 75 mg administered in the evening. Number of capsules taken daily with placebo matched the number taken for the assigned pregabalin dose level.
Change From Baseline in Endpoint Mean Pain Score During the Double-blind Treatment Period at Week 14	-2.01 Units on a scale Standard Error 0.148	-1.28 Units on a scale Standard Error 0.150

SECONDARY outcome

Timeframe: Week 14

Population: The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication.

The Patient Global Impression of Change (PGIC) was a participant-rated instrument that measured change in participant's overall status on a scale ranging from 1 (very much improved) to 7 (very much worse), which was based on a validated scale, the Clinical Global Impression of Change (CGIC). Categories were defined based on the PGIC scores as followed: 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse and 7 = very much worse.

Outcome measures

Measure	Pregabalin n=142 Participants Pregabalin was administered orally, at a dose level of 75 mg (1 capsule) twice daily (BID) (Day 0 evening - Day 7 morning) and 150 mg (1 capsule) BID (Day 7 evening - Day 14 morning) in the titration phase. Pregabalin was then administered at a dose level of 150 mg (1 capsule) BID or 225 mg (2 capsules; 75 mg + 150 mg) BID in Day 14 evening and Weeks 3 - 14 during the fixed-dose phase. A 1-week taper off dose phase was in the following with pregabalin 150 mg or 225 mg administered in the morning and 75 mg administered in the evening.	Placebo n=142 Participants Placebo matched to pregabalin 75 mg (1 capsule) was administered twice daily (BID) (Day 0 evening - Day 7 morning) and 150 mg (1 capsule) BID (Day 7 evening - Day 14 morning) in the titration phase. Placebo was then administered as matched to pregabalin 150 mg (1 capsule) BID or 225 mg (2 capsules; 75 mg + 150 mg) BID in Day 14 evening and Weeks 3 - 14 during the fixed-dose phase. A 1-week taper off dose phase was in the following with placebo matched to pregabalin 150 mg or 225 mg administered in the morning and 75 mg administered in the evening. Number of capsules taken daily with placebo matched the number taken for the assigned pregabalin dose level.
Percentage of Participants Categorized by Each Patient Global Impression of Change (PGIC) Score at Week 14 Very much improved	9.9 Percentage of participants	7.7 Percentage of participants
Percentage of Participants Categorized by Each Patient Global Impression of Change (PGIC) Score at Week 14 Much improved	25.4 Percentage of participants	19.7 Percentage of participants
Percentage of Participants Categorized by Each Patient Global Impression of Change (PGIC) Score at Week 14 Minimally improved	40.1 Percentage of participants	42.3 Percentage of participants
Percentage of Participants Categorized by Each Patient Global Impression of Change (PGIC) Score at Week 14 No change	17.6 Percentage of participants	24.6 Percentage of participants
Percentage of Participants Categorized by Each Patient Global Impression of Change (PGIC) Score at Week 14 Minimally worse	4.9 Percentage of participants	3.5 Percentage of participants
Percentage of Participants Categorized by Each Patient Global Impression of Change (PGIC) Score at Week 14 Much worse	2.1 Percentage of participants	2.1 Percentage of participants
Percentage of Participants Categorized by Each Patient Global Impression of Change (PGIC) Score at Week 14 Very much worse	0.0 Percentage of participants	0.0 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 14

Population: The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used.

The Fibromyalgia Impact Questionnaire (FIQ) was a 20-item participant-reported outcome instrument designed to assess health status, progress, and outcomes in participants with fibromyalgia. It contained 10 subscales. There were 11 questions that are related specifically to physical functioning. The remaining items assessed pain, fatigue, stiffness, difficulty working, and symptoms of anxiousness and depression. Score range for each subscale was 0 to 10. The 10 subscales were combined to yield a total score with range from 0 to 100. The total score provided an estimation of fibromyalgia impact with higher scores indicating greater impairment.

Outcome measures

Measure	Pregabalin n=170 Participants Pregabalin was administered orally, at a dose level of 75 mg (1 capsule) twice daily (BID) (Day 0 evening - Day 7 morning) and 150 mg (1 capsule) BID (Day 7 evening - Day 14 morning) in the titration phase. Pregabalin was then administered at a dose level of 150 mg (1 capsule) BID or 225 mg (2 capsules; 75 mg + 150 mg) BID in Day 14 evening and Weeks 3 - 14 during the fixed-dose phase. A 1-week taper off dose phase was in the following with pregabalin 150 mg or 225 mg administered in the morning and 75 mg administered in the evening.	Placebo n=164 Participants Placebo matched to pregabalin 75 mg (1 capsule) was administered twice daily (BID) (Day 0 evening - Day 7 morning) and 150 mg (1 capsule) BID (Day 7 evening - Day 14 morning) in the titration phase. Placebo was then administered as matched to pregabalin 150 mg (1 capsule) BID or 225 mg (2 capsules; 75 mg + 150 mg) BID in Day 14 evening and Weeks 3 - 14 during the fixed-dose phase. A 1-week taper off dose phase was in the following with placebo matched to pregabalin 150 mg or 225 mg administered in the morning and 75 mg administered in the evening. Number of capsules taken daily with placebo matched the number taken for the assigned pregabalin dose level.
Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Score at Week 14	-11.14 Units on a scale Standard Error 1.343	-8.15 Units on a scale Standard Error 1.367

SECONDARY outcome

Timeframe: Baseline, Week 14

Population: The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used.

Assessment of mean pain score was based on participant's daily pain diary. The daily pain diary consisted of an 11-point numeric rating scale ranging from 0 (no pain) to 10 (worst possible pain). The participants rated their pain during the past 24 hours by choosing the appropriate number between 0 and 10. Self-assessment was performed daily at awakening. Weekly mean pain score was calculated as mean value of the observations within the window for each week during the double-blind treatment phase. A participant with at least 30% reduction in weekly mean pain score from baseline to Week 14 was defined as a 30% responder.

Outcome measures

Measure	Pregabalin n=162 Participants Pregabalin was administered orally, at a dose level of 75 mg (1 capsule) twice daily (BID) (Day 0 evening - Day 7 morning) and 150 mg (1 capsule) BID (Day 7 evening - Day 14 morning) in the titration phase. Pregabalin was then administered at a dose level of 150 mg (1 capsule) BID or 225 mg (2 capsules; 75 mg + 150 mg) BID in Day 14 evening and Weeks 3 - 14 during the fixed-dose phase. A 1-week taper off dose phase was in the following with pregabalin 150 mg or 225 mg administered in the morning and 75 mg administered in the evening.	Placebo n=159 Participants Placebo matched to pregabalin 75 mg (1 capsule) was administered twice daily (BID) (Day 0 evening - Day 7 morning) and 150 mg (1 capsule) BID (Day 7 evening - Day 14 morning) in the titration phase. Placebo was then administered as matched to pregabalin 150 mg (1 capsule) BID or 225 mg (2 capsules; 75 mg + 150 mg) BID in Day 14 evening and Weeks 3 - 14 during the fixed-dose phase. A 1-week taper off dose phase was in the following with placebo matched to pregabalin 150 mg or 225 mg administered in the morning and 75 mg administered in the evening. Number of capsules taken daily with placebo matched the number taken for the assigned pregabalin dose level.
Percentage of Participants With at Least 30% Reduction in Weekly Mean Pain Score From Baseline to Week 14	47.5 Percentage of participants	32.7 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 14

Population: The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used.

Assessment of mean pain score was based on participant's daily pain diary. The daily pain diary consisted of an 11-point numeric rating scale ranging from 0 (no pain) to 10 (worst possible pain). The participants rated their pain during the past 24 hours by choosing the appropriate number between 0 and 10. Self-assessment was performed daily at awakening. Weekly mean pain score was calculated as mean value of the observations within the window for each week during the double-blind treatment phase. A participant with at least 50% reduction in weekly mean pain score from baseline to Week 14 was defined as a 50% responder.

Outcome measures

Measure	Pregabalin n=162 Participants Pregabalin was administered orally, at a dose level of 75 mg (1 capsule) twice daily (BID) (Day 0 evening - Day 7 morning) and 150 mg (1 capsule) BID (Day 7 evening - Day 14 morning) in the titration phase. Pregabalin was then administered at a dose level of 150 mg (1 capsule) BID or 225 mg (2 capsules; 75 mg + 150 mg) BID in Day 14 evening and Weeks 3 - 14 during the fixed-dose phase. A 1-week taper off dose phase was in the following with pregabalin 150 mg or 225 mg administered in the morning and 75 mg administered in the evening.	Placebo n=159 Participants Placebo matched to pregabalin 75 mg (1 capsule) was administered twice daily (BID) (Day 0 evening - Day 7 morning) and 150 mg (1 capsule) BID (Day 7 evening - Day 14 morning) in the titration phase. Placebo was then administered as matched to pregabalin 150 mg (1 capsule) BID or 225 mg (2 capsules; 75 mg + 150 mg) BID in Day 14 evening and Weeks 3 - 14 during the fixed-dose phase. A 1-week taper off dose phase was in the following with placebo matched to pregabalin 150 mg or 225 mg administered in the morning and 75 mg administered in the evening. Number of capsules taken daily with placebo matched the number taken for the assigned pregabalin dose level.
Percentage of Participants With at Least 50% Reduction in Weekly Mean Pain Score From Baseline to Week 14	27.2 Percentage of participants	17.0 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 14

Population: The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used.

The Medical Outcomes Study (MOS)-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assess key constructs of sleep. Instrument scoring yields 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. Range of scores represented for sleep disturbance was 0 to 100, with higher scores indicating more of the attribute.

Outcome measures

Measure	Pregabalin n=169 Participants Pregabalin was administered orally, at a dose level of 75 mg (1 capsule) twice daily (BID) (Day 0 evening - Day 7 morning) and 150 mg (1 capsule) BID (Day 7 evening - Day 14 morning) in the titration phase. Pregabalin was then administered at a dose level of 150 mg (1 capsule) BID or 225 mg (2 capsules; 75 mg + 150 mg) BID in Day 14 evening and Weeks 3 - 14 during the fixed-dose phase. A 1-week taper off dose phase was in the following with pregabalin 150 mg or 225 mg administered in the morning and 75 mg administered in the evening.	Placebo n=164 Participants Placebo matched to pregabalin 75 mg (1 capsule) was administered twice daily (BID) (Day 0 evening - Day 7 morning) and 150 mg (1 capsule) BID (Day 7 evening - Day 14 morning) in the titration phase. Placebo was then administered as matched to pregabalin 150 mg (1 capsule) BID or 225 mg (2 capsules; 75 mg + 150 mg) BID in Day 14 evening and Weeks 3 - 14 during the fixed-dose phase. A 1-week taper off dose phase was in the following with placebo matched to pregabalin 150 mg or 225 mg administered in the morning and 75 mg administered in the evening. Number of capsules taken daily with placebo matched the number taken for the assigned pregabalin dose level.
Change From Baseline at Week 14 in Medical Outcome Study (MOS)-Sleep Scale - Sleep Disturbance Subscale Score	-11.45 Units on a scale Standard Error 1.608	-8.02 Units on a scale Standard Error 1.636

SECONDARY outcome

Timeframe: Baseline, Week 14

Population: The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used.

The Medical Outcomes Study (MOS)-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assess key constructs of sleep. Instrument scoring yields 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. Range of scores represented for snoring, awaken short of breath and sleep adequacy was 0 to 100, with higher scores indicating more of the attribute.

Outcome measures

Measure	Pregabalin n=170 Participants Pregabalin was administered orally, at a dose level of 75 mg (1 capsule) twice daily (BID) (Day 0 evening - Day 7 morning) and 150 mg (1 capsule) BID (Day 7 evening - Day 14 morning) in the titration phase. Pregabalin was then administered at a dose level of 150 mg (1 capsule) BID or 225 mg (2 capsules; 75 mg + 150 mg) BID in Day 14 evening and Weeks 3 - 14 during the fixed-dose phase. A 1-week taper off dose phase was in the following with pregabalin 150 mg or 225 mg administered in the morning and 75 mg administered in the evening.	Placebo n=164 Participants Placebo matched to pregabalin 75 mg (1 capsule) was administered twice daily (BID) (Day 0 evening - Day 7 morning) and 150 mg (1 capsule) BID (Day 7 evening - Day 14 morning) in the titration phase. Placebo was then administered as matched to pregabalin 150 mg (1 capsule) BID or 225 mg (2 capsules; 75 mg + 150 mg) BID in Day 14 evening and Weeks 3 - 14 during the fixed-dose phase. A 1-week taper off dose phase was in the following with placebo matched to pregabalin 150 mg or 225 mg administered in the morning and 75 mg administered in the evening. Number of capsules taken daily with placebo matched the number taken for the assigned pregabalin dose level.
Change From Baseline at Week 14 in Medical Outcome Study (MOS)-Sleep Scale - Snoring, Awaken Short of Breath and Sleep Adequacy Subscale Scores Snoring	4.61 Units on a scale Standard Error 1.748	2.08 Units on a scale Standard Error 1.777
Change From Baseline at Week 14 in Medical Outcome Study (MOS)-Sleep Scale - Snoring, Awaken Short of Breath and Sleep Adequacy Subscale Scores Awaken Short of Breath	-6.76 Units on a scale Standard Error 1.809	-4.41 Units on a scale Standard Error 1.842
Change From Baseline at Week 14 in Medical Outcome Study (MOS)-Sleep Scale - Snoring, Awaken Short of Breath and Sleep Adequacy Subscale Scores Sleep Adequacy	14.23 Units on a scale Standard Error 1.940	5.20 Units on a scale Standard Error 1.990

SECONDARY outcome

Timeframe: Baseline, Week 14

Population: The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used.

The Medical Outcomes Study (MOS)-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assess key constructs of sleep. Instrument scoring yields 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. Range of quantity of sleep parameter was 0 to 24 and somnolence was 0 to 100, with higher scores indicating more of the attribute.

Outcome measures

Measure	Pregabalin n=170 Participants Pregabalin was administered orally, at a dose level of 75 mg (1 capsule) twice daily (BID) (Day 0 evening - Day 7 morning) and 150 mg (1 capsule) BID (Day 7 evening - Day 14 morning) in the titration phase. Pregabalin was then administered at a dose level of 150 mg (1 capsule) BID or 225 mg (2 capsules; 75 mg + 150 mg) BID in Day 14 evening and Weeks 3 - 14 during the fixed-dose phase. A 1-week taper off dose phase was in the following with pregabalin 150 mg or 225 mg administered in the morning and 75 mg administered in the evening.	Placebo n=163 Participants Placebo matched to pregabalin 75 mg (1 capsule) was administered twice daily (BID) (Day 0 evening - Day 7 morning) and 150 mg (1 capsule) BID (Day 7 evening - Day 14 morning) in the titration phase. Placebo was then administered as matched to pregabalin 150 mg (1 capsule) BID or 225 mg (2 capsules; 75 mg + 150 mg) BID in Day 14 evening and Weeks 3 - 14 during the fixed-dose phase. A 1-week taper off dose phase was in the following with placebo matched to pregabalin 150 mg or 225 mg administered in the morning and 75 mg administered in the evening. Number of capsules taken daily with placebo matched the number taken for the assigned pregabalin dose level.
Change From Baseline at Week 14 in Medical Outcome Study (MOS)-Sleep Scale - Quantity of Sleep and Somnolence Subscale Scores Quantity of Sleep	0.61 Units on a scale Standard Error 0.089	0.32 Units on a scale Standard Error 0.090
Change From Baseline at Week 14 in Medical Outcome Study (MOS)-Sleep Scale - Quantity of Sleep and Somnolence Subscale Scores Somnolence	-1.29 Units on a scale Standard Error 1.311	-5.48 Units on a scale Standard Error 1.337

SECONDARY outcome

Timeframe: Baseline, Week 14

Population: The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used.

The Medical Outcomes Study (MOS)-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assess key constructs of sleep. Instrument scoring yields 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. Range of sleep problem index overall score was 0 to 100, with higher scores indicating more of the attribute.

Outcome measures

Measure	Pregabalin n=169 Participants Pregabalin was administered orally, at a dose level of 75 mg (1 capsule) twice daily (BID) (Day 0 evening - Day 7 morning) and 150 mg (1 capsule) BID (Day 7 evening - Day 14 morning) in the titration phase. Pregabalin was then administered at a dose level of 150 mg (1 capsule) BID or 225 mg (2 capsules; 75 mg + 150 mg) BID in Day 14 evening and Weeks 3 - 14 during the fixed-dose phase. A 1-week taper off dose phase was in the following with pregabalin 150 mg or 225 mg administered in the morning and 75 mg administered in the evening.	Placebo n=163 Participants Placebo matched to pregabalin 75 mg (1 capsule) was administered twice daily (BID) (Day 0 evening - Day 7 morning) and 150 mg (1 capsule) BID (Day 7 evening - Day 14 morning) in the titration phase. Placebo was then administered as matched to pregabalin 150 mg (1 capsule) BID or 225 mg (2 capsules; 75 mg + 150 mg) BID in Day 14 evening and Weeks 3 - 14 during the fixed-dose phase. A 1-week taper off dose phase was in the following with placebo matched to pregabalin 150 mg or 225 mg administered in the morning and 75 mg administered in the evening. Number of capsules taken daily with placebo matched the number taken for the assigned pregabalin dose level.
Change From Baseline at Week 14 in Medical Outcome Study (MOS)-Sleep Scale - Sleep Problems Index Overall Score	-9.70 Units on a scale Standard Error 1.307	-6.64 Units on a scale Standard Error 1.334

SECONDARY outcome

Timeframe: Baseline, Week 14

Population: The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used.

The Medical Outcomes Study (MOS)-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assess key constructs of sleep. Instrument scoring yields 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.

Outcome measures

Measure	Pregabalin n=170 Participants Pregabalin was administered orally, at a dose level of 75 mg (1 capsule) twice daily (BID) (Day 0 evening - Day 7 morning) and 150 mg (1 capsule) BID (Day 7 evening - Day 14 morning) in the titration phase. Pregabalin was then administered at a dose level of 150 mg (1 capsule) BID or 225 mg (2 capsules; 75 mg + 150 mg) BID in Day 14 evening and Weeks 3 - 14 during the fixed-dose phase. A 1-week taper off dose phase was in the following with pregabalin 150 mg or 225 mg administered in the morning and 75 mg administered in the evening.	Placebo n=163 Participants Placebo matched to pregabalin 75 mg (1 capsule) was administered twice daily (BID) (Day 0 evening - Day 7 morning) and 150 mg (1 capsule) BID (Day 7 evening - Day 14 morning) in the titration phase. Placebo was then administered as matched to pregabalin 150 mg (1 capsule) BID or 225 mg (2 capsules; 75 mg + 150 mg) BID in Day 14 evening and Weeks 3 - 14 during the fixed-dose phase. A 1-week taper off dose phase was in the following with placebo matched to pregabalin 150 mg or 225 mg administered in the morning and 75 mg administered in the evening. Number of capsules taken daily with placebo matched the number taken for the assigned pregabalin dose level.
Percentage of Participants With Optimal Sleep at Week 14 in Medical Outcome Study (MOS)-Sleep Scale	41.2 Percentage of participants 41.2	43.6 Percentage of participants 43.6

SECONDARY outcome

Timeframe: Baseline, Week 14

Population: The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication.

The Daily Sleep Interference Scale was an 11-point numerical scale ranging from 0 (does not interfere with sleep) to 10 (completely interferes [unable to sleep due to pain]). Participants were asked to describe how their pain had interfered with their sleep during the past 24 hours by choosing the appropriate number between 0 and 10. Self-assessment was performed daily upon awakening. Baseline Mean Sleep Interference score was defined as the mean of all available last 7 sleep interference score diary entries up to and including Day 1.

Outcome measures

Measure	Pregabalin n=128 Participants Pregabalin was administered orally, at a dose level of 75 mg (1 capsule) twice daily (BID) (Day 0 evening - Day 7 morning) and 150 mg (1 capsule) BID (Day 7 evening - Day 14 morning) in the titration phase. Pregabalin was then administered at a dose level of 150 mg (1 capsule) BID or 225 mg (2 capsules; 75 mg + 150 mg) BID in Day 14 evening and Weeks 3 - 14 during the fixed-dose phase. A 1-week taper off dose phase was in the following with pregabalin 150 mg or 225 mg administered in the morning and 75 mg administered in the evening.	Placebo n=124 Participants Placebo matched to pregabalin 75 mg (1 capsule) was administered twice daily (BID) (Day 0 evening - Day 7 morning) and 150 mg (1 capsule) BID (Day 7 evening - Day 14 morning) in the titration phase. Placebo was then administered as matched to pregabalin 150 mg (1 capsule) BID or 225 mg (2 capsules; 75 mg + 150 mg) BID in Day 14 evening and Weeks 3 - 14 during the fixed-dose phase. A 1-week taper off dose phase was in the following with placebo matched to pregabalin 150 mg or 225 mg administered in the morning and 75 mg administered in the evening. Number of capsules taken daily with placebo matched the number taken for the assigned pregabalin dose level.
Change From Baseline in Mean Sleep Interference Score at Week 14	-1.88 Units on a scale Standard Error 0.150	-1.00 Units on a scale Standard Error 0.153

SECONDARY outcome

Timeframe: Baseline, Week 14

Population: The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication.

The Subjective Sleep Questionnaire (SSQ) was included in the participant's diary and designed to capture subjective evaluation of sleep behavior in participants with disrupted sleep. It was administered to each participant approximately 30 - 60 minutes after arising each day in the morning. The Subjective Wake after Sleep Onset (sWASO) parameter subjectively estimated the total amount of time the participant was awake after initial sleep onset until final awakening. Baseline was defined as the mean of last 7 SSQ diary entries up to and including Day 1.

Outcome measures

Measure	Pregabalin n=121 Participants Pregabalin was administered orally, at a dose level of 75 mg (1 capsule) twice daily (BID) (Day 0 evening - Day 7 morning) and 150 mg (1 capsule) BID (Day 7 evening - Day 14 morning) in the titration phase. Pregabalin was then administered at a dose level of 150 mg (1 capsule) BID or 225 mg (2 capsules; 75 mg + 150 mg) BID in Day 14 evening and Weeks 3 - 14 during the fixed-dose phase. A 1-week taper off dose phase was in the following with pregabalin 150 mg or 225 mg administered in the morning and 75 mg administered in the evening.	Placebo n=117 Participants Placebo matched to pregabalin 75 mg (1 capsule) was administered twice daily (BID) (Day 0 evening - Day 7 morning) and 150 mg (1 capsule) BID (Day 7 evening - Day 14 morning) in the titration phase. Placebo was then administered as matched to pregabalin 150 mg (1 capsule) BID or 225 mg (2 capsules; 75 mg + 150 mg) BID in Day 14 evening and Weeks 3 - 14 during the fixed-dose phase. A 1-week taper off dose phase was in the following with placebo matched to pregabalin 150 mg or 225 mg administered in the morning and 75 mg administered in the evening. Number of capsules taken daily with placebo matched the number taken for the assigned pregabalin dose level.
Change From Baseline at Week 14 in Subjective Sleep Questionnaire (SSQ) - Subjective Wake After Sleep Onset (sWASO)	-42.36 Minutes Standard Error 5.920	-25.19 Minutes Standard Error 6.010

SECONDARY outcome

Timeframe: Baseline, Week 14

Population: The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication.

The Subjective Sleep Questionnaire (SSQ) was included in the participant's diary and designed to capture subjective evaluation of sleep behavior in participants with disrupted sleep. It was administered to each participant approximately 30 - 60 minutes after arising each day in the morning. The Subjective Latency to Sleep Onset (sLSO) parameter subjectively estimated the amount of time to fall asleep after lights out. Baseline was defined as the mean of last 7 SSQ diary entries up to and including Day 1.

Outcome measures

Measure	Pregabalin n=124 Participants Pregabalin was administered orally, at a dose level of 75 mg (1 capsule) twice daily (BID) (Day 0 evening - Day 7 morning) and 150 mg (1 capsule) BID (Day 7 evening - Day 14 morning) in the titration phase. Pregabalin was then administered at a dose level of 150 mg (1 capsule) BID or 225 mg (2 capsules; 75 mg + 150 mg) BID in Day 14 evening and Weeks 3 - 14 during the fixed-dose phase. A 1-week taper off dose phase was in the following with pregabalin 150 mg or 225 mg administered in the morning and 75 mg administered in the evening.	Placebo n=122 Participants Placebo matched to pregabalin 75 mg (1 capsule) was administered twice daily (BID) (Day 0 evening - Day 7 morning) and 150 mg (1 capsule) BID (Day 7 evening - Day 14 morning) in the titration phase. Placebo was then administered as matched to pregabalin 150 mg (1 capsule) BID or 225 mg (2 capsules; 75 mg + 150 mg) BID in Day 14 evening and Weeks 3 - 14 during the fixed-dose phase. A 1-week taper off dose phase was in the following with placebo matched to pregabalin 150 mg or 225 mg administered in the morning and 75 mg administered in the evening. Number of capsules taken daily with placebo matched the number taken for the assigned pregabalin dose level.
Change From Baseline at Week 14 in Subjective Sleep Questionnaire (SSQ) - Subjective Latency to Sleep Onset (sLSO)	-0.26 Minutes Standard Error 0.052	-0.28 Minutes Standard Error 0.053

SECONDARY outcome

Timeframe: Baseline, Week 14

Population: The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication.

The Subjective Sleep Questionnaire (SSQ) was included in the participant's diary and designed to capture subjective evaluation of sleep behavior in participants with disrupted sleep. It was administered to each participant approximately 30 - 60 minutes after arising each day in the morning. The Subjective Number of Awakenings after Sleep Onset (sNAASO) parameter subjectively estimated the total number of times the participant awakened during the night until final awakening. Baseline was defined as the mean of last 7 SSQ diary entries up to and including Day 1.

Outcome measures

Measure	Pregabalin n=127 Participants Pregabalin was administered orally, at a dose level of 75 mg (1 capsule) twice daily (BID) (Day 0 evening - Day 7 morning) and 150 mg (1 capsule) BID (Day 7 evening - Day 14 morning) in the titration phase. Pregabalin was then administered at a dose level of 150 mg (1 capsule) BID or 225 mg (2 capsules; 75 mg + 150 mg) BID in Day 14 evening and Weeks 3 - 14 during the fixed-dose phase. A 1-week taper off dose phase was in the following with pregabalin 150 mg or 225 mg administered in the morning and 75 mg administered in the evening.	Placebo n=123 Participants Placebo matched to pregabalin 75 mg (1 capsule) was administered twice daily (BID) (Day 0 evening - Day 7 morning) and 150 mg (1 capsule) BID (Day 7 evening - Day 14 morning) in the titration phase. Placebo was then administered as matched to pregabalin 150 mg (1 capsule) BID or 225 mg (2 capsules; 75 mg + 150 mg) BID in Day 14 evening and Weeks 3 - 14 during the fixed-dose phase. A 1-week taper off dose phase was in the following with placebo matched to pregabalin 150 mg or 225 mg administered in the morning and 75 mg administered in the evening. Number of capsules taken daily with placebo matched the number taken for the assigned pregabalin dose level.
Change From Baseline at Week 14 in Subjective Sleep Questionnaire (SSQ) - Subjective Number of Awakenings After Sleep Onset (sNAASO)	-0.95 Awakenings Standard Error 0.094	-0.30 Awakenings Standard Error 0.095

SECONDARY outcome

Timeframe: Baseline, Week 14

Population: The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication.

The Subjective Sleep Questionnaire (SSQ) was included in the participant's diary and designed to capture subjective evaluation of sleep behavior in participants with disrupted sleep. It was administered to each participant approximately 30 - 60 minutes after arising each day in the morning. The Subjective Total Sleep Time (sTST) parameter subjectively estimated the total amount of time the participant was asleep after lights out until final awakening. Baseline was defined as the mean of last 7 SSQ diary entries up to and including Day 1.

Outcome measures

Measure	Pregabalin n=127 Participants Pregabalin was administered orally, at a dose level of 75 mg (1 capsule) twice daily (BID) (Day 0 evening - Day 7 morning) and 150 mg (1 capsule) BID (Day 7 evening - Day 14 morning) in the titration phase. Pregabalin was then administered at a dose level of 150 mg (1 capsule) BID or 225 mg (2 capsules; 75 mg + 150 mg) BID in Day 14 evening and Weeks 3 - 14 during the fixed-dose phase. A 1-week taper off dose phase was in the following with pregabalin 150 mg or 225 mg administered in the morning and 75 mg administered in the evening.	Placebo n=121 Participants Placebo matched to pregabalin 75 mg (1 capsule) was administered twice daily (BID) (Day 0 evening - Day 7 morning) and 150 mg (1 capsule) BID (Day 7 evening - Day 14 morning) in the titration phase. Placebo was then administered as matched to pregabalin 150 mg (1 capsule) BID or 225 mg (2 capsules; 75 mg + 150 mg) BID in Day 14 evening and Weeks 3 - 14 during the fixed-dose phase. A 1-week taper off dose phase was in the following with placebo matched to pregabalin 150 mg or 225 mg administered in the morning and 75 mg administered in the evening. Number of capsules taken daily with placebo matched the number taken for the assigned pregabalin dose level.
Change From Baseline at Week 14 in Subjective Sleep Questionnaire (SSQ) - Subjective Total Sleep Time (sTST)	24.63 Minutes Standard Error 5.851	17.23 Minutes Standard Error 5.958

SECONDARY outcome

Timeframe: Baseline, Week 14

Population: The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication.

The Subjective Sleep Questionnaire (SSQ) was included in the participant's diary and designed to capture subjective evaluation of sleep behavior in participants with disrupted sleep. It was administered to each participant approximately 30 - 60 minutes after arising each day in the morning. The Sleep Quality parameter subjectively rated the quality of sleep during the past night by selecting a number between 0 (very poor) and 10 (excellent). Baseline was defined as the mean of last 7 SSQ diary entries up to and including Day 1.

Outcome measures

Measure	Pregabalin n=127 Participants Pregabalin was administered orally, at a dose level of 75 mg (1 capsule) twice daily (BID) (Day 0 evening - Day 7 morning) and 150 mg (1 capsule) BID (Day 7 evening - Day 14 morning) in the titration phase. Pregabalin was then administered at a dose level of 150 mg (1 capsule) BID or 225 mg (2 capsules; 75 mg + 150 mg) BID in Day 14 evening and Weeks 3 - 14 during the fixed-dose phase. A 1-week taper off dose phase was in the following with pregabalin 150 mg or 225 mg administered in the morning and 75 mg administered in the evening.	Placebo n=123 Participants Placebo matched to pregabalin 75 mg (1 capsule) was administered twice daily (BID) (Day 0 evening - Day 7 morning) and 150 mg (1 capsule) BID (Day 7 evening - Day 14 morning) in the titration phase. Placebo was then administered as matched to pregabalin 150 mg (1 capsule) BID or 225 mg (2 capsules; 75 mg + 150 mg) BID in Day 14 evening and Weeks 3 - 14 during the fixed-dose phase. A 1-week taper off dose phase was in the following with placebo matched to pregabalin 150 mg or 225 mg administered in the morning and 75 mg administered in the evening. Number of capsules taken daily with placebo matched the number taken for the assigned pregabalin dose level.
Change From Baseline at Week 14 in Subjective Sleep Questionnaire (SSQ) - Sleep Quality	1.59 Units on a scale Standard Error 0.166	0.82 Units on a scale Standard Error 0.169

SECONDARY outcome

Timeframe: Baseline, Week 14

Population: The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used.

The Multidimensional Assessment of Fatigue (MAF) scale was a self-administered survey that yielded a Global Fatigue Index by assessing the participant's level of fatigue and the degree to which fatigue interferes with activities of daily living. It contained 16 items and measured 4 dimensions of fatigue: severity (2 items), distress (1 item), degree of interference in activities of daily living (11 items), and timing (2 items). Index range was 1 to 50 and higher scores reflected greater impairment.

Outcome measures

Measure	Pregabalin n=166 Participants Pregabalin was administered orally, at a dose level of 75 mg (1 capsule) twice daily (BID) (Day 0 evening - Day 7 morning) and 150 mg (1 capsule) BID (Day 7 evening - Day 14 morning) in the titration phase. Pregabalin was then administered at a dose level of 150 mg (1 capsule) BID or 225 mg (2 capsules; 75 mg + 150 mg) BID in Day 14 evening and Weeks 3 - 14 during the fixed-dose phase. A 1-week taper off dose phase was in the following with pregabalin 150 mg or 225 mg administered in the morning and 75 mg administered in the evening.	Placebo n=161 Participants Placebo matched to pregabalin 75 mg (1 capsule) was administered twice daily (BID) (Day 0 evening - Day 7 morning) and 150 mg (1 capsule) BID (Day 7 evening - Day 14 morning) in the titration phase. Placebo was then administered as matched to pregabalin 150 mg (1 capsule) BID or 225 mg (2 capsules; 75 mg + 150 mg) BID in Day 14 evening and Weeks 3 - 14 during the fixed-dose phase. A 1-week taper off dose phase was in the following with placebo matched to pregabalin 150 mg or 225 mg administered in the morning and 75 mg administered in the evening. Number of capsules taken daily with placebo matched the number taken for the assigned pregabalin dose level.
Change From Baseline in Multidimensional Assessment of Fatigue (MAF) Score at Week 14	-4.09 Units on a scale Standard Error 0.676	-3.25 Units on a scale Standard Error 0.681

SECONDARY outcome

Timeframe: Baseline, Week 14

Population: The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used.

The Short-Form 36 Health Survey (SF-36) was a self-administered questionnaire that measured each of the following 8 health concepts: Physical functioning, role limitations due to physical problems, social functioning, bodily pain, mental health, role limitations due to emotional problems, vitality, and general health perception. Mental component included mental health, role limitations due to emotional problems, vitality and general health perception. Score range for mental component summary score was 0 to 100 and higher scores reflected better participant status.

Outcome measures

Measure	Pregabalin n=170 Participants Pregabalin was administered orally, at a dose level of 75 mg (1 capsule) twice daily (BID) (Day 0 evening - Day 7 morning) and 150 mg (1 capsule) BID (Day 7 evening - Day 14 morning) in the titration phase. Pregabalin was then administered at a dose level of 150 mg (1 capsule) BID or 225 mg (2 capsules; 75 mg + 150 mg) BID in Day 14 evening and Weeks 3 - 14 during the fixed-dose phase. A 1-week taper off dose phase was in the following with pregabalin 150 mg or 225 mg administered in the morning and 75 mg administered in the evening.	Placebo n=164 Participants Placebo matched to pregabalin 75 mg (1 capsule) was administered twice daily (BID) (Day 0 evening - Day 7 morning) and 150 mg (1 capsule) BID (Day 7 evening - Day 14 morning) in the titration phase. Placebo was then administered as matched to pregabalin 150 mg (1 capsule) BID or 225 mg (2 capsules; 75 mg + 150 mg) BID in Day 14 evening and Weeks 3 - 14 during the fixed-dose phase. A 1-week taper off dose phase was in the following with placebo matched to pregabalin 150 mg or 225 mg administered in the morning and 75 mg administered in the evening. Number of capsules taken daily with placebo matched the number taken for the assigned pregabalin dose level.
Change From Baseline at Week 14 in Short-Form 36 (SF-36) Health Survey - Mental Component Summary Score	2.68 Units on a scale Standard Error 0.831	2.30 Units on a scale Standard Error 0.846

SECONDARY outcome

Timeframe: Baseline, Week 14

Population: The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used.

The Short-Form 36 Health Survey (SF-36) was a self-administered questionnaire that measured each of the following 8 health concepts: Physical functioning, role limitations due to physical problems, social functioning, bodily pain, mental health, role limitations due to emotional problems, vitality, and general health perception. Physical component included physical functioning, role limitations due to physical problems, social functioning and bodily pain. Score range for physical component summary score was 0 to 100 and higher scores reflected better participant status.

Outcome measures

Measure	Pregabalin n=170 Participants Pregabalin was administered orally, at a dose level of 75 mg (1 capsule) twice daily (BID) (Day 0 evening - Day 7 morning) and 150 mg (1 capsule) BID (Day 7 evening - Day 14 morning) in the titration phase. Pregabalin was then administered at a dose level of 150 mg (1 capsule) BID or 225 mg (2 capsules; 75 mg + 150 mg) BID in Day 14 evening and Weeks 3 - 14 during the fixed-dose phase. A 1-week taper off dose phase was in the following with pregabalin 150 mg or 225 mg administered in the morning and 75 mg administered in the evening.	Placebo n=164 Participants Placebo matched to pregabalin 75 mg (1 capsule) was administered twice daily (BID) (Day 0 evening - Day 7 morning) and 150 mg (1 capsule) BID (Day 7 evening - Day 14 morning) in the titration phase. Placebo was then administered as matched to pregabalin 150 mg (1 capsule) BID or 225 mg (2 capsules; 75 mg + 150 mg) BID in Day 14 evening and Weeks 3 - 14 during the fixed-dose phase. A 1-week taper off dose phase was in the following with placebo matched to pregabalin 150 mg or 225 mg administered in the morning and 75 mg administered in the evening. Number of capsules taken daily with placebo matched the number taken for the assigned pregabalin dose level.
Change From Baseline at Week 14 in Short-Form 36 (SF-36) Health Survey - Physical Component Summary Score	4.44 Units on a scale Standard Error 0.538	3.66 Units on a scale Standard Error 0.548

SECONDARY outcome

Timeframe: Baseline, Week 14

Population: The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used.

The Pain Visual Analog Scale (Pain VAS) was a horizontal line; 100 mm in length, self administered by the participants in order to rate pain from 0 "no pain" to 100 "worst possible pain".

Outcome measures

Measure	Pregabalin n=170 Participants Pregabalin was administered orally, at a dose level of 75 mg (1 capsule) twice daily (BID) (Day 0 evening - Day 7 morning) and 150 mg (1 capsule) BID (Day 7 evening - Day 14 morning) in the titration phase. Pregabalin was then administered at a dose level of 150 mg (1 capsule) BID or 225 mg (2 capsules; 75 mg + 150 mg) BID in Day 14 evening and Weeks 3 - 14 during the fixed-dose phase. A 1-week taper off dose phase was in the following with pregabalin 150 mg or 225 mg administered in the morning and 75 mg administered in the evening.	Placebo n=164 Participants Placebo matched to pregabalin 75 mg (1 capsule) was administered twice daily (BID) (Day 0 evening - Day 7 morning) and 150 mg (1 capsule) BID (Day 7 evening - Day 14 morning) in the titration phase. Placebo was then administered as matched to pregabalin 150 mg (1 capsule) BID or 225 mg (2 capsules; 75 mg + 150 mg) BID in Day 14 evening and Weeks 3 - 14 during the fixed-dose phase. A 1-week taper off dose phase was in the following with placebo matched to pregabalin 150 mg or 225 mg administered in the morning and 75 mg administered in the evening. Number of capsules taken daily with placebo matched the number taken for the assigned pregabalin dose level.
Change From Baseline in Pain Visual Analog Scale (Pain VAS) Score at Week 14	-17.04 Units on a scale Standard Error 1.922	-13.43 Units on a scale Standard Error 1.952

SECONDARY outcome

Timeframe: Baseline, Week 14

Population: The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used.

The Hospital Anxiety and Depression Scale (HADS) was a self-reported 14-item instrument that consisted of two 7-item subscales that measure the presence and severity of anxiety and depression. For each subscale, score range was 0 to 21, with higher scores indicating greater impairment.

Outcome measures

Measure	Pregabalin n=170 Participants Pregabalin was administered orally, at a dose level of 75 mg (1 capsule) twice daily (BID) (Day 0 evening - Day 7 morning) and 150 mg (1 capsule) BID (Day 7 evening - Day 14 morning) in the titration phase. Pregabalin was then administered at a dose level of 150 mg (1 capsule) BID or 225 mg (2 capsules; 75 mg + 150 mg) BID in Day 14 evening and Weeks 3 - 14 during the fixed-dose phase. A 1-week taper off dose phase was in the following with pregabalin 150 mg or 225 mg administered in the morning and 75 mg administered in the evening.	Placebo n=164 Participants Placebo matched to pregabalin 75 mg (1 capsule) was administered twice daily (BID) (Day 0 evening - Day 7 morning) and 150 mg (1 capsule) BID (Day 7 evening - Day 14 morning) in the titration phase. Placebo was then administered as matched to pregabalin 150 mg (1 capsule) BID or 225 mg (2 capsules; 75 mg + 150 mg) BID in Day 14 evening and Weeks 3 - 14 during the fixed-dose phase. A 1-week taper off dose phase was in the following with placebo matched to pregabalin 150 mg or 225 mg administered in the morning and 75 mg administered in the evening. Number of capsules taken daily with placebo matched the number taken for the assigned pregabalin dose level.
Change From Baseline at Week 14 in Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale Score	-1.03 Units on a scale Standard Error 0.287	-0.65 Units on a scale Standard Error 0.292

SECONDARY outcome

Timeframe: Baseline, Week 14

Population: The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used.

The Hospital Anxiety and Depression Scale (HADS) was a self-reported 14-item instrument that consisted of two 7-item subscales that measure the presence and severity of anxiety and depression. For each subscale, range was 0 to 21, with higher scores indicating greater impairment.

Outcome measures

Measure	Pregabalin n=170 Participants Pregabalin was administered orally, at a dose level of 75 mg (1 capsule) twice daily (BID) (Day 0 evening - Day 7 morning) and 150 mg (1 capsule) BID (Day 7 evening - Day 14 morning) in the titration phase. Pregabalin was then administered at a dose level of 150 mg (1 capsule) BID or 225 mg (2 capsules; 75 mg + 150 mg) BID in Day 14 evening and Weeks 3 - 14 during the fixed-dose phase. A 1-week taper off dose phase was in the following with pregabalin 150 mg or 225 mg administered in the morning and 75 mg administered in the evening.	Placebo n=164 Participants Placebo matched to pregabalin 75 mg (1 capsule) was administered twice daily (BID) (Day 0 evening - Day 7 morning) and 150 mg (1 capsule) BID (Day 7 evening - Day 14 morning) in the titration phase. Placebo was then administered as matched to pregabalin 150 mg (1 capsule) BID or 225 mg (2 capsules; 75 mg + 150 mg) BID in Day 14 evening and Weeks 3 - 14 during the fixed-dose phase. A 1-week taper off dose phase was in the following with placebo matched to pregabalin 150 mg or 225 mg administered in the morning and 75 mg administered in the evening. Number of capsules taken daily with placebo matched the number taken for the assigned pregabalin dose level.
Change From Baseline at Week 14 in Hospital Anxiety and Depression Scale (HADS) - Depression Subscale Score	-1.11 Units on a scale Standard Error 0.290	-0.28 Units on a scale Standard Error 0.294

SECONDARY outcome

Timeframe: Baseline to Follow up (Day 105)

Population: The Safety Analysis Set was defined as all randomized participants who received at least 1 dose of study medication.

An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device. A Serious adverse event (SAE) was any untoward medical occurrence at any dose that resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect. Treatment-emergent AEs (TEAEs) were events between first dose of study drug and up to follow-up visit (Study Day 105) that were absent before treatment or that worsened after treatment. AEs included both SAEs and non-SAEs.

Outcome measures

Measure	Pregabalin n=170 Participants Pregabalin was administered orally, at a dose level of 75 mg (1 capsule) twice daily (BID) (Day 0 evening - Day 7 morning) and 150 mg (1 capsule) BID (Day 7 evening - Day 14 morning) in the titration phase. Pregabalin was then administered at a dose level of 150 mg (1 capsule) BID or 225 mg (2 capsules; 75 mg + 150 mg) BID in Day 14 evening and Weeks 3 - 14 during the fixed-dose phase. A 1-week taper off dose phase was in the following with pregabalin 150 mg or 225 mg administered in the morning and 75 mg administered in the evening.	Placebo n=164 Participants Placebo matched to pregabalin 75 mg (1 capsule) was administered twice daily (BID) (Day 0 evening - Day 7 morning) and 150 mg (1 capsule) BID (Day 7 evening - Day 14 morning) in the titration phase. Placebo was then administered as matched to pregabalin 150 mg (1 capsule) BID or 225 mg (2 capsules; 75 mg + 150 mg) BID in Day 14 evening and Weeks 3 - 14 during the fixed-dose phase. A 1-week taper off dose phase was in the following with placebo matched to pregabalin 150 mg or 225 mg administered in the morning and 75 mg administered in the evening. Number of capsules taken daily with placebo matched the number taken for the assigned pregabalin dose level.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs AEs	119 Participants	103 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs SAEs	0 Participants	9 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs Discontinuation due to AEs	22 Participants	11 Participants

SECONDARY outcome

Timeframe: Baseline to Follow up (Day 105)

Population: The Safety Analysis Set was defined as all randomized participants who received at least 1 dose of study medication.

A mild Adverse Event (AE) was an AE that did not interfere with participant's usual function. A moderate AE was an AE that interfered participant's usual function to some extent. A severe AE was an AE that interfered significantly with participant's usual function.

Outcome measures

Measure	Pregabalin n=170 Participants Pregabalin was administered orally, at a dose level of 75 mg (1 capsule) twice daily (BID) (Day 0 evening - Day 7 morning) and 150 mg (1 capsule) BID (Day 7 evening - Day 14 morning) in the titration phase. Pregabalin was then administered at a dose level of 150 mg (1 capsule) BID or 225 mg (2 capsules; 75 mg + 150 mg) BID in Day 14 evening and Weeks 3 - 14 during the fixed-dose phase. A 1-week taper off dose phase was in the following with pregabalin 150 mg or 225 mg administered in the morning and 75 mg administered in the evening.	Placebo n=164 Participants Placebo matched to pregabalin 75 mg (1 capsule) was administered twice daily (BID) (Day 0 evening - Day 7 morning) and 150 mg (1 capsule) BID (Day 7 evening - Day 14 morning) in the titration phase. Placebo was then administered as matched to pregabalin 150 mg (1 capsule) BID or 225 mg (2 capsules; 75 mg + 150 mg) BID in Day 14 evening and Weeks 3 - 14 during the fixed-dose phase. A 1-week taper off dose phase was in the following with placebo matched to pregabalin 150 mg or 225 mg administered in the morning and 75 mg administered in the evening. Number of capsules taken daily with placebo matched the number taken for the assigned pregabalin dose level.
Number of Treatment-Emergent Adverse Events (TEAEs) Categorized by Severity Mild AEs	183 Events	162 Events
Number of Treatment-Emergent Adverse Events (TEAEs) Categorized by Severity Moderate AEs	52 Events	30 Events
Number of Treatment-Emergent Adverse Events (TEAEs) Categorized by Severity Severe AEs	38 Events	25 Events

Adverse Events

Pregabalin

Serious events: 0 serious events

Other events: 88 other events

Deaths: 0 deaths

Placebo

Serious events: 9 serious events

Other events: 47 other events

Deaths: 0 deaths

Serious adverse events

Measure	Pregabalin n=170 participants at risk Pregabalin was administered orally, at a dose level of 75 mg (1 capsule) twice daily (BID) (Day 0 evening - Day 7 morning) and 150 mg (1 capsule) BID (Day 7 evening - Day 14 morning) in the titration phase. Pregabalin was then administered at a dose level of 150 mg (1 capsule) BID or 225 mg (2 capsules; 75 mg + 150 mg) BID in Day 14 evening and Weeks 3 - 14 during the fixed-dose phase. A 1-week taper off dose phase was in the following with pregabalin 150 mg or 225 mg administered in the morning and 75 mg administered in the evening.	Placebo n=164 participants at risk Placebo matched to pregabalin 75 mg (1 capsule) was administered twice daily (BID) (Day 0 evening - Day 7 morning) and 150 mg (1 capsule) BID (Day 7 evening - Day 14 morning) in the titration phase. Placebo was then administered as matched to pregabalin 150 mg (1 capsule) BID or 225 mg (2 capsules; 75 mg + 150 mg) BID in Day 14 evening and Weeks 3 - 14 during the fixed-dose phase. A 1-week taper off dose phase was in the following with placebo matched to pregabalin 150 mg or 225 mg administered in the morning and 75 mg administered in the evening. Number of capsules taken daily with placebo matched the number taken for the assigned pregabalin dose level.
Cardiac disorders Atrial tachycardia	0.00% 0/170 • Baseline to Follow up (Day 105)	0.61% 1/164 • Baseline to Follow up (Day 105)
Endocrine disorders Goitre	0.00% 0/170 • Baseline to Follow up (Day 105)	0.61% 1/164 • Baseline to Follow up (Day 105)
Hepatobiliary disorders Bile duct stone	0.00% 0/170 • Baseline to Follow up (Day 105)	0.61% 1/164 • Baseline to Follow up (Day 105)
Infections and infestations Biliary tract infection	0.00% 0/170 • Baseline to Follow up (Day 105)	0.61% 1/164 • Baseline to Follow up (Day 105)
Injury, poisoning and procedural complications Tibia fracture	0.00% 0/170 • Baseline to Follow up (Day 105)	0.61% 1/164 • Baseline to Follow up (Day 105)
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/170 • Baseline to Follow up (Day 105)	0.61% 1/164 • Baseline to Follow up (Day 105)
Musculoskeletal and connective tissue disorders Fibromyalgia	0.00% 0/170 • Baseline to Follow up (Day 105)	0.61% 1/164 • Baseline to Follow up (Day 105)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cerebral haemangioma	0.00% 0/170 • Baseline to Follow up (Day 105)	0.61% 1/164 • Baseline to Follow up (Day 105)
Nervous system disorders Cerebral haemorrhage	0.00% 0/170 • Baseline to Follow up (Day 105)	0.61% 1/164 • Baseline to Follow up (Day 105)
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/170 • Baseline to Follow up (Day 105)	0.61% 1/164 • Baseline to Follow up (Day 105)
Respiratory, thoracic and mediastinal disorders Nasal obstruction	0.00% 0/170 • Baseline to Follow up (Day 105)	0.61% 1/164 • Baseline to Follow up (Day 105)

Other adverse events

Measure	Pregabalin n=170 participants at risk Pregabalin was administered orally, at a dose level of 75 mg (1 capsule) twice daily (BID) (Day 0 evening - Day 7 morning) and 150 mg (1 capsule) BID (Day 7 evening - Day 14 morning) in the titration phase. Pregabalin was then administered at a dose level of 150 mg (1 capsule) BID or 225 mg (2 capsules; 75 mg + 150 mg) BID in Day 14 evening and Weeks 3 - 14 during the fixed-dose phase. A 1-week taper off dose phase was in the following with pregabalin 150 mg or 225 mg administered in the morning and 75 mg administered in the evening.	Placebo n=164 participants at risk Placebo matched to pregabalin 75 mg (1 capsule) was administered twice daily (BID) (Day 0 evening - Day 7 morning) and 150 mg (1 capsule) BID (Day 7 evening - Day 14 morning) in the titration phase. Placebo was then administered as matched to pregabalin 150 mg (1 capsule) BID or 225 mg (2 capsules; 75 mg + 150 mg) BID in Day 14 evening and Weeks 3 - 14 during the fixed-dose phase. A 1-week taper off dose phase was in the following with placebo matched to pregabalin 150 mg or 225 mg administered in the morning and 75 mg administered in the evening. Number of capsules taken daily with placebo matched the number taken for the assigned pregabalin dose level.
Infections and infestations Upper respiratory tract infection	5.9% 10/170 • Baseline to Follow up (Day 105)	4.3% 7/164 • Baseline to Follow up (Day 105)
Nervous system disorders Dizziness	41.8% 71/170 • Baseline to Follow up (Day 105)	18.3% 30/164 • Baseline to Follow up (Day 105)
Nervous system disorders Headache	5.9% 10/170 • Baseline to Follow up (Day 105)	6.1% 10/164 • Baseline to Follow up (Day 105)
Nervous system disorders Somnolence	17.6% 30/170 • Baseline to Follow up (Day 105)	7.9% 13/164 • Baseline to Follow up (Day 105)

Additional Information

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