Pregabalin for Treatment of Patients With Postherpetic Neuralgia (PHN)

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01455428
• Collaborator: (none)
• Enrollment: 223
• Locations: 22
• Arms: 2
• Duration (Months): 25
• Patients Per Site: 10.1
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

To prove pregabalin is effective in relieving pain compared with placebo in subjects with postherpetic neuralgia (PHN).

Condition or Disease	Intervention/Treatment	Phase
Postherpetic Neuralgia ( PHN )	Drug: Lyrica (pregabalin); Drug: Placebo	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 223 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: An 8-week Randomized, Double Blind, Multi-center, Placebo-controlled Study To Evaluate The Efficacy, Safety And Tolerability Of Pregabalin ( 300mg/Day ) Using A Fixed Dosing Schedule In The Treatment Of Subjects With Postherpetic Neuralgia ( Phn )
• Study Start Date: Dec 1, 2011
• Actual Primary Completion Date: Jan 1, 2014
• Actual Study Completion Date: Jan 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lyrica (pregabalin)	Drug: Lyrica (pregabalin); Capsule, 300 mg/d, BID, 8 weeks treatment
Placebo Comparator: Placebo	Drug: Placebo; Capsule, 300 mg/d, BID, 8 weeks treatment

Outcome Measures

Primary Outcome Measures

1. Baseline Mean Pain Score [Baseline]

   The daily pain rating scale (DPRS) consists of an 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10.

2. Change From Baseline in Mean Pain Score at Endpoint [Baseline until end of fixed dose phase (Day 57/Week 8)/Early Termination (Study Endpoint)]

   The daily pain rating scale (DPRS) consists of an 11-point numeric scale ranging from 0 ("no pain") to 10 ("worst possible pain"). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10. The mean endpoint pain score was obtained from the last 7 available DPRS scores of the daily pain diary while the participant was on study medication, up to and including the day after the last Week 8 (Day 57) dose.

Secondary Outcome Measures

1. Change From Baseline in Weekly Mean Pain Score at Weeks 1 to 8 [Baseline and weekly from Weeks 1 to 8]

   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.

2. Baseline Mean Sleep Interference Score [Baseline]

   Pain-related sleep interference was assessed on an 11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]). Participants were to describe how their pain had interfered with their sleep during the past 24 hours by choosing the appropriate number between 0 and 10.

3. Change From Baseline in Mean Sleep Interference Score at Endpoint [Baseline until end of fixed dose phase (Day 57/Week 8)/Early Termination (Study Endpoint)]

   Pain-related sleep interference was assessed on an 11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]). Participants were to describe how their pain had interfered with their sleep during the past 24 hours by choosing the appropriate number between 0 and 10. The mean endpoint score was obtained from the last 7 available scores of the daily diary while the participant was on study medication, up to and including the day after the last Week 8 (Day 57) dose.

4. Change From Baseline in Weekly Mean Sleep Interference Scores at Weeks 1 to 8 [Baseline and weekly from Weeks 1 to 8]

   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.

5. Percentage of 30 Percent (%) Responders at Endpoint [End of fixed dose phase (Day 57/Week 8)/Early Termination (Study Endpoint)]

   The DPRS consists of an 11-point numeric scale ranging from 0 ("no pain") to 10 ("worst possible pain"). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10. A 30% responder was a participant who had 30% reduction or more in mean pain score at the end of the fixed dose phase (Day 57/Week 8)/Early Termination (Study Endpoint) compared to baseline.

6. Change From Baseline in Short Form McGill Pain Questionnaire (SF-MPQ) Score at Weeks 1, 3, 5, and 8 [Baseline; Weeks 1, 3, 5, and 8]

   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.

7. Baseline Pain Visual Analogue Scale (VAS) and Present Pain Intensity (PPI) Scale [Baseline]

   The VAS was part of the Short Form McGill Pain Questionnaire (SF-MPQ) scale and reflected the overall pain intensity score, The pain VAS was a horizontal line; 100 millimeters (mm) in length, was self-administered by the participant in order to rate pain from 0 (no pain) to 100 (worst possible pain). The PPI was part of the SF-MPQ scale and measured the participant's present pain intensity on a 6-point scale ranging from 0 (no pain) to 5 (excruciating).

8. Change From Baseline in Pain VAS From the SF-MPQ at Endpoint [Baseline to Day 57 (Week 8)/Early Termination (Study Endpoint)]

   The VAS was part of the SF-MPQ scale and reflected the overall pain intensity score. The pain VAS was a horizontal line; 100 mm in length, was self-administered by the participant in order to rate pain from 0 (no pain) to 100 (worst possible pain).

9. Change From Baseline in PPI Scale From the SF-MPQ at Endpoint [Baseline to Day 57 (Week 8)/Early Termination (Study Endpoint)]

   The PPI was part of the SF-MPQ scale and measured the participant's present pain intensity on a 6-point scale ranging from 0 (no pain) to 5 (excruciating).

10. Baseline Medical Outcomes Study (MOS)-Sleep Scale Scores [Baseline]

    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. With the exception of sleep adequacy, optimal sleep, and quantity, higher scores reflected greater impairment in the MOS-Sleep subscales. The MOS-Sleep Scale was used to evaluate sleep during the previous week.

11. Change From Baseline in MOS-Sleep Scale, Sleep Disturbance Score at Endpoint [Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)]

    The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. For sleep disturbance, the subscale score also ranged from 0 to 100, with higher scores representing greater sleep disturbance.

12. Change From Baseline in MOS-Sleep Scale, Snoring Score at Endpoint [Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)]

    The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The snoring subscale score also ranged from 0 to 100, with lower scores indicating less snoring.

13. Change From Baseline in MOS-Sleep Scale, Awaken Short of Breath Score at Endpoint [Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)]

    The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The awaken short of breath subscale also ranged from 0 to 100, with lower scores indicating less difficulty in breathing.

14. Change From Baseline in MOS-Sleep Scale, Quantity of Sleep Score at Endpoint [Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)]

    The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The MOS Sleep Quantity sub-scale scores ranged from 0 to 24 (number of hours slept).

15. Percentage of Participants Who Had Optimal Sleep at Endpoint [Day 57 (Week 8)/Early Termination (Study Endpoint)]

    The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The MOS optimal sleep subscale was a binary outcome derived from the sleep quantity responses: the response was YES if sleep quantity was 7 or 8 hours per night.

16. Change From Baseline in MOS-Sleep Scale, Sleep Adequacy Score at Endpoint [Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)]

    The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The sleep adequacy subscale also ranged from 0 to 100, with higher scores indicating greater sleep adequacy.

17. Change From Baseline in MOS-Sleep Scale, Somnolence Score at Endpoint [Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)]

    The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The somnolence subscale score also ranged from 0 to 100, with lower scores indicating less somnolence.

18. Change From Baseline in MOS-Sleep Scale, Sleep Problems Index Score at Endpoint [Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)]

    The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The sleep problems index subscale score also ranged from 0 to 100, with lower scores indicating fewer sleep problems.

19. Clinical Global Impression of Change (CGIC) Score at Endpoint [Day 57 (Week 8)/Early Termination (Study Endpoint)]

    The CGIC was a clinician-rated global measure that provided a clinically relevant and easy to interpret account of a clinician's perception of the clinical importance of the participant's improvement or worsening during their involvement in a clinical study. Clinicians rated the participant's overall improvement on a 7-point scale where scores ranged from 1 (very much improved) to 7 (very much worse).

20. Patient Global Impression of Change (PGIC) Score at Endpoint [Day 57 (Week 8)/Early Termination (Study Endpoint)]

    The PGIC was a participant-rated global measure that provided a clinically relevant and easy to interpret account of a participant's perception of the clinical importance of their own improvement or worsening during their involvement in a clinical study. Participants rated their overall improvement on a 7-point scale where scores ranged from 1 (very much improved) to 7 (very much worse).

21. Baseline Hospital Anxiety and Depression Scale (HADS) Scores [Baseline]

    The HADS was a self-administered questionnaire that consisted of 2 subscales, 1 measuring anxiety (HADS-A Scale) and the other measuring depression (HADS-D Scale). Each subscale comprised of 7 items; participants assessed how each item applied to them on a scale of 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Subscores from HADS-A (Anxiety) and HADS-D (Depression) were not to be combined. The interpretation of each HADS subscales was as follows: 0-7 normal, 8-10 mild, 11-14 moderate and 15-21 severe.

22. Change From Baseline in HADS Anxiety Total Score at Endpoint [Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)]

    The HADS was a self-administered questionnaire that consisted of 2 subscales, 1 measuring anxiety (HADS-A Scale) and the other measuring depression (HADS-D Scale). Each subscale was comprised of 7 items; participants assessed how each item applied to them on a scale of 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Subscores from HADS-A (Anxiety) and HADS-D (Depression) were not to be combined. The interpretation of each HADS subscales was as follows: 0-7 normal, 8-10 mild, 11-14 moderate and 15-21 severe.

23. Change From Baseline in HADS Depression Total Score at Endpoint [Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)]

    The HADS was a self-administered questionnaire that consisted of 2 subscales, 1 measuring anxiety (HADS-A Scale) and the other measuring depression (HADS-D Scale). Each subscale was comprised of 7 items; participants assessed how each item applied to them on a scale of 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Subscores from HADS-A (Anxiety) and HADS-D (Depression) were not to be combined. The interpretation of each HADS subscales was as follows: 0-7 normal, 8-10 mild, 11-14 moderate and 15-21 severe.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male or female Chinese subjects, ages ≥18 at screening

• Subjects with symptoms of neuropathic pain associated with postherpetic neuralgia (PHN). Subjects must have pain present for ﹥3 months after healing of the acute herpes zoster skin rash

• At screening (V1), subjects must have a score ≥40mm on the 100-mm visual analog scale (VAS) of the Short Form-McGill Pain Questionnaire (SF-MPQ, see Appendix 3)

• At randomization (V2), subjects must have a score ≥40mm on the 100-mm visual analog scale (VAS) of the Short Form-McGill Pain Questionnaire (SF-MPQ, see Appendix 3)

• At randomization (V2), subjects must have completed at least 5 daily pain diaries (DPRS, see Appendix 2) and have an average daily pain score ≥4 over the past 7 days

Exclusion Criteria:

• Subjects who demonstrate a high response to placebo, with 30% decrease on the Pain Visual Analog Scale (VAS) at randomization as compared to screening

• Subjects who have a high variability in pain scores during the 1 week screening period, with any difference between two scores ﹥3

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking University First Hospital	Beijing	Beijing	China	100034
2	Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University	Guangzhou	Guangdong	China	510120
3	Shenzhen People's Hospital	Shenzhen	Guangdong	China	518020
4	Union Hospital of Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei	China	430022
5	Tongji Hospital Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei	China	430030
6	Neurology Department, Jiangsu Province Hospital	Nanjing	Jiangsu	China	210029
7	The Second Affiliated Hospital of Soochow University/Neurology Department	Suzhou	Jiangsu	China	215004
8	Qilu Hospital of Shandong University	Jinan	Shandong	China	250012
9	The First Affiliated Hospital of College of Medicine, Zhejiang University/Dermatology and STD Dept.	Hangzhou	Zhejiang	China	310003
10	Sir Run Run Shaw Hospital Affiliated of College of Medicine, Zhejiang University/Neurology Dept.	Hangzhou	Zhejiang	China	310016
11	Beijing Friendship Hospital, Capital Medical University/Department of Internal Neurology	Beijing		China	100050
12	Peking University Third Hospital, Neurology Department	Beijing		China	100191
13	Neurology Department, Beijing Hospital of the Ministry of Health	Beijing		China	100730
14	West China Hospital of Sichuan University, Neurology Department	Chengdu/wuhou D		China	610041
15	the first affiliated hospital ,chongqing medical university, Department of Neurology	Chongqing		China	400016
16	GuangZhou First Municipal People's Hospital	Guangzhou		China	510180
17	The Third Affiliated Hospital of Sun Yat-sen University	Guangzhou		China	510630
18	Neurology Department, Shanghai Changzheng Hospital	Shang Hai		China	200003
19	Huashan Hospital, Fudan University/Neurology Department	Shang Hai		China	200040
20	Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine	Shanghai		China	200025
21	Renji Hospital Shanghai Jiao Tong University School of Medicine/Neurology Department	Shanghai		China	200127
22	Tianjin Medical University General Hospital, Dermatological Department	Tianjin		China	300052

Sponsors and Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• ClinicalTrials.gov Identifier: NCT01455428
• Other Study ID Numbers: A0081276
• First Posted: Oct 20, 2011
• Last Update Posted: Jan 28, 2021
• Last Verified: May 1, 2015

• Keywords provided by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: Pregabalin; Postherpetic Neuralgia ( PHN )
• Additional relevant MeSH terms: Neuralgia; Neuralgia, Postherpetic; Pregabalin

Study Results

Participant Flow

Recruitment Details	223 participants were randomized, as stated on clinicaltrials.gov. However, 1 was randomized by mistake, was considered a screen failure, and was not given any medication. As such, the actual number of participants randomized and assigned to treatment was 222.

Arm/Group Title	Pregabalin	Placebo
Arm/Group Description	Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).	Participants received matching placebo capsule(s) for a period of 10 weeks.
Period Title: Overall Study
STARTED	112	110
Treated	111	109
COMPLETED	98	92
NOT COMPLETED	14	18

Baseline Characteristics

Arm/Group Title	Pregabalin	Placebo	Total
Arm/Group Description	Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).	Participants received matching placebo capsule(s) for a period of 10 weeks.	Total of all reporting groups
Overall Participants	111	109	220
Age, Customized (participants) [Number]
18-44 years	4 3.6%	3 2.8%	7 3.2%
45-64 years	39 35.1%	47 43.1%	86 39.1%
More than or equal to (>=)65 years	68 61.3%	59 54.1%	127 57.7%
Sex: Female, Male (Count of Participants)
Female	54 48.6%	47 43.1%	101 45.9%
Male	57 51.4%	62 56.9%	119 54.1%

Outcome Measures

1. Primary Outcome

Title	Baseline Mean Pain Score
Description	The daily pain rating scale (DPRS) consists of an 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

All participants in the Full Analysis Set (FAS) population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The Last Observation Carried Forward (LOCF) method was used.

Arm/Group Title	Pregabalin	Placebo
Arm/Group Description	Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).	Participants received matching placebo capsule(s) for a period of 10 weeks
Measure Participants	111	108
Mean (Standard Deviation) [units on a scale]	5.93 (1.304)	6.08 (1.266)

2. Primary Outcome

Title	Change From Baseline in Mean Pain Score at Endpoint
Description	The daily pain rating scale (DPRS) consists of an 11-point numeric scale ranging from 0 ("no pain") to 10 ("worst possible pain"). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10. The mean endpoint pain score was obtained from the last 7 available DPRS scores of the daily pain diary while the participant was on study medication, up to and including the day after the last Week 8 (Day 57) dose.
Time Frame	Baseline until end of fixed dose phase (Day 57/Week 8)/Early Termination (Study Endpoint)

Outcome Measure Data

Analysis Population Description

All participants in the Full Analysis Set (FAS) population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The Last Observation Carried Forward (LOCF) method was used.

Arm/Group Title	Pregabalin	Placebo
Arm/Group Description	Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).	Participants received matching placebo capsule(s) for a period of 10 weeks
Measure Participants	111	108
Least Squares Mean (Standard Error) [units on a scale]	-1.81 (0.137)	-1.09 (0.142)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Analysis performed using a general linear model with treatment and center as factors, and baseline value as a covariate.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.0002
	Comments	Primary analysis was two-sided and performed at the 0.05 significance level.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.71
	Confidence Interval	(2-Sided) 95%; -1.08 to -0.34
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.188
	Estimation Comments

3. Secondary Outcome

Title	Change From Baseline in Weekly Mean Pain Score at Weeks 1 to 8
Description	The DPRS consists of an 11-point numeric scale ranging from 0 ("no pain") to 10 ("worst possible pain"). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10. The weekly mean pain score was the sum of the daily scores divided by the number of diary entries during that week.
Time Frame	Baseline and weekly from Weeks 1 to 8

Outcome Measure Data

Analysis Population Description

The FAS population consisted of all participants randomized to treatment that received at least 1 dose of study medication.

Arm/Group Title	Pregabalin	Placebo
Arm/Group Description	Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).	Participants received matching placebo capsule(s) for a period of 10 weeks
Measure Participants	111	109
Week 1 change from baseline	-0.62 (0.108)	-0.12 (0.111)
Week 2 change from baseline	-1.00 (0.109)	-0.35 (0.112)
Week 3 change from baseline	-1.23 (0.109)	-0.65 (0.112)
Week 4 change from baseline	-1.36 (0.110)	-0.85 (0.114)
Week 5 change from baseline	-1.50 (0.110)	-0.99 (0.114)
Week 6 change from baseline	-1.70 (0.110)	-1.11 (0.114)
Week 7 change from baseline	-1.78 (0.111)	-1.07 (0.114)
Week 8 change from baseline	-1.91 (0.111)	-1.21 (0.114)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Week 1 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.0010
	Comments	All analyses were 2-sided and performed at the 0.05 significance level.
	Method	Mixed Model Repeated Measures Analysis
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.49
	Confidence Interval	(2-Sided) 95%; -0.79 to -0.20
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.149
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Week 2 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	All analyses were 2-sided and performed at the 0.05 significance level.
	Method	Mixed Model Repeated Measures Analysis
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.65
	Confidence Interval	(2-Sided) 95%; -0.94 to -0.35
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.150
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Week 3 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.0001
	Comments	All analyses were 2-sided and performed at the 0.05 significance level.
	Method	Mixed Model Repeated Measures Analysis
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.58
	Confidence Interval	(2-Sided) 95%; -0.88 to -0.29
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.151
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Week 4 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.0009
	Comments	All analyses were 2-sided and performed at the 0.05 significance level.
	Method	Mixed Model Repeated Measures Analysis
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.51
	Confidence Interval	(2-Sided) 95%; -0.81 to -0.21
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.152
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Week 5 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.0009
	Comments	All analyses were 2-sided and performed at the 0.05 significance level.
	Method	Mixed Model Repeated Measures Analysis
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.51
	Confidence Interval	(2-Sided) 95%; -0.81 to -0.21
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.153
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Week 6 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.0001
	Comments	All analyses were 2-sided and performed at the 0.05 significance level.
	Method	Mixed Model Repeated Measures Analysis
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.59
	Confidence Interval	(2-Sided) 95%; -0.89 to -0.29
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.153
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Week 7 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	All analyses were 2-sided and performed at the 0.05 significance level.
	Method	Mixed Model Repeated Measures Analysis
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.71
	Confidence Interval	(2-Sided) 95%; -1.01 to -0.41
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.154
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Week 8 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	All analyses were 2-sided and performed at the 0.05 significance level.
	Method	Mixed Model Repeated Measures Analysis
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.70
	Confidence Interval	(2-Sided) 95%; -1.00 to -0.40
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.154
	Estimation Comments

4. Secondary Outcome

Title	Baseline Mean Sleep Interference Score
Description	Pain-related sleep interference was assessed on an 11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]). Participants were to describe how their pain had interfered with their sleep during the past 24 hours by choosing the appropriate number between 0 and 10.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.

Arm/Group Title	Pregabalin	Placebo
Arm/Group Description	Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).	Participants received matching placebo capsule(s) for a period of 10 weeks
Measure Participants	111	108
Mean (Standard Deviation) [units on a scale]	3.81 (2.436)	4.54 (2.027)

5. Secondary Outcome

Title	Change From Baseline in Mean Sleep Interference Score at Endpoint
Description	Pain-related sleep interference was assessed on an 11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]). Participants were to describe how their pain had interfered with their sleep during the past 24 hours by choosing the appropriate number between 0 and 10. The mean endpoint score was obtained from the last 7 available scores of the daily diary while the participant was on study medication, up to and including the day after the last Week 8 (Day 57) dose.
Time Frame	Baseline until end of fixed dose phase (Day 57/Week 8)/Early Termination (Study Endpoint)

Outcome Measure Data

Analysis Population Description

All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.

Arm/Group Title	Pregabalin	Placebo
Arm/Group Description	Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).	Participants received matching placebo capsule(s) for a period of 10 weeks
Measure Participants	111	108
Least Squares Mean (Standard Error) [units on a scale]	-1.24 (0.145)	-0.70 (0.150)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Analysis performed using a general linear model with treatment and center as factors, and baseline value as a covariate.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.0079
	Comments	Analysis was two-sided and performed at the 0.05 significance level.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.54
	Confidence Interval	(2-Sided) 95%; -0.93 to -0.14
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.200
	Estimation Comments

6. Secondary Outcome

Title	Change From Baseline in Weekly Mean Sleep Interference Scores at Weeks 1 to 8
Description	Pain-related sleep interference was assessed on an 11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]). Participants were to describe how their pain had interfered with their sleep during the past 24 hours by choosing the appropriate number between 0 and 10. The weekly mean score was the sum of the daily scores divided by the number of diary entries during that week.
Time Frame	Baseline and weekly from Weeks 1 to 8

Outcome Measure Data

Analysis Population Description

The FAS population consisted of all participants randomized to treatment that received at least 1 dose of study medication.

Arm/Group Title	Pregabalin	Placebo
Arm/Group Description	Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).	Participants received matching placebo capsule(s) for a period of 10 weeks
Measure Participants	111	109
Week 1 change from baseline	-0.52 (0.124)	0.01 (0.128)
Week 2 change from baseline	-0.82 (0.124)	-0.16 (0.128)
Week 3 change from baseline	-0.92 (0.125)	-0.35 (0.129)
Week 4 change from baseline	-0.96 (0.125)	-0.51 (0.130)
Week 5 change from baseline	-1.02 (0.126)	-0.62 (0.130)
Week 6 change from baseline	-1.13 (0.126)	-0.74 (0.130)
Week 7 change from baseline	-1.27 (0.126)	-0.79 (0.130)
Week 8 change from baseline	-1.31 (0.126)	-0.84 (0.131)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Week 1 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.0024
	Comments	Analysis was two-sided and performed at the 0.05 significance level.
	Method	Mixed Model Repeated Measures Analysis
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.52
	Confidence Interval	(2-Sided) 95%; -0.86 to -0.19
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.172
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Week 2 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.0002
	Comments	Analysis was two-sided and performed at the 0.05 significance level.
	Method	Mixed Model Repeated Measures Analysis
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.65
	Confidence Interval	(2-Sided) 95%; -0.99 to -0.31
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.173
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Week 3 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.0012
	Comments	Analysis was two-sided and performed at the 0.05 significance level.
	Method	Mixed Model Repeated Measures Analysis
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.57
	Confidence Interval	(2-Sided) 95%; -0.91 to -0.22
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.173
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Week 4 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.0101
	Comments	Analysis was two-sided and performed at the 0.05 significance level.
	Method	Mixed Model Repeated Measures Analysis
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.45
	Confidence Interval	(2-Sided) 95%; -0.79 to -0.11
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.174
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Week 5 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.0258
	Comments	Analysis was two-sided and performed at the 0.05 significance level.
	Method	Mixed Model Repeated Measures Analysis
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.39
	Confidence Interval	(2-Sided) 95%; -0.73 to -0.05
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.175
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Week 6 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.0260
	Comments	Analysis was two-sided and performed at the 0.05 significance level.
	Method	Mixed Model Repeated Measures Analysis
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.39
	Confidence Interval	(2-Sided) 95%; -0.74 to -0.05
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.175
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Week 7 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.0062
	Comments	Analysis was two-sided and performed at the 0.05 significance level.
	Method	Mixed Model Repeated Measures Analysis
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.48
	Confidence Interval	(2-Sided) 95%; -0.83 to -0.14
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.175
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Week 8 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.0081
	Comments	Analysis was two-sided and performed at the 0.05 significance level.
	Method	Mixed Model Repeated Measures Analysis
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.47
	Confidence Interval	(2-Sided) 95%; -0.81 to -0.12
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.176
	Estimation Comments

7. Secondary Outcome

Title	Percentage of 30 Percent (%) Responders at Endpoint
Description	The DPRS consists of an 11-point numeric scale ranging from 0 ("no pain") to 10 ("worst possible pain"). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10. A 30% responder was a participant who had 30% reduction or more in mean pain score at the end of the fixed dose phase (Day 57/Week 8)/Early Termination (Study Endpoint) compared to baseline.
Time Frame	End of fixed dose phase (Day 57/Week 8)/Early Termination (Study Endpoint)

Outcome Measure Data

Analysis Population Description

All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.

Arm/Group Title	Pregabalin	Placebo
Arm/Group Description	Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).	Participants received matching placebo capsule(s) for a period of 10 weeks
Measure Participants	111	108
Number [percentage of participants]	52.3 47.1%	30.6 28.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Cochran-Mantel-Haenszel test comparing pregabalin to placebo adjusted for center.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.0007
	Comments	Analysis was two-sided and performed at the 0.05 significance level
	Method	Cochran-Mantel-Haenszel
	Comments

8. Secondary Outcome

Title	Change From Baseline in Short Form McGill Pain Questionnaire (SF-MPQ) Score at Weeks 1, 3, 5, and 8
Description	SF-MPQ was assessed according to the participant's answer to the SF-MPQ questionnaire. The score for each composite scale (sensory, affective, and total) was derived by summing the reported intensity value for each item within a particular scale where None=0, Mild=1, Moderate=2, and Severe=3. The sensory score was the sum of the scores of the first 11 pain descriptors (throbbing, shooting, stabbing, sharp, cramping, gnawing, hot-burning, aching, heavy, tender, and splitting) and could range from 0-33. The affective score was the sum of the scores of the last 4 pain descriptors (tiring-exhausting, sickening, fearful, and punishing-cruel) and could range from 0-12. The total score was the sum of the scores of all 15 pain descriptors and could range from 0 to 45. Higher scores indicated greater pain.
Time Frame	Baseline; Weeks 1, 3, 5, and 8

Outcome Measure Data

Analysis Population Description

The FAS population consisted of all participants randomized to treatment that received at least 1 dose of study medication. N=the number of participants who were evaluable for this measure at the given time point.

Arm/Group Title	Pregabalin	Placebo
Arm/Group Description	Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).	Participants received matching placebo capsule(s) for a period of 10 weeks
Measure Participants	111	109
Sensory score, Baseline	8.24 (5.276)	8.00 (4.939)
Sensory score, Week 1 change (N=111, 106)	-1.68 (3.776)	-0.29 (3.009)
Sensory score, Week 3 change (N=107, 101)	-2.97 (3.852)	-1.05 (3.810)
Sensory score, Week 5 change (N=102, 96)	-3.31 (4.496)	-1.79 (4.058)
Sensory score, Week 8 change (N=98, 93)	-3.61 (4.299)	-1.94 (4.418)
Affective score, Baseline	1.25 (2.038)	1.31 (2.124)
Affective score, Week 1 change (N=111, 105)	-0.61 (1.602)	-0.28 (1.404)
Affective score, Week 3 change (N=107, 100)	-0.80 (1.772)	-0.46 (1.507)
Affective score, Week 5 change (N=102, 95)	-0.85 (2.036)	-0.59 (1.512)
Affective score, Week 8 change (N=97,90)	-0.96 (1.941)	-0.66 (1.630)
Total score, Baseline	9.50 (6.621)	9.29 (6.465)
Total score, Week 1 change (N=111, 106)	-2.29 (4.486)	-0.57 (3.494)
Total score, Week 3 change (N=107, 101)	-3.77 (4.761)	-1.51 (4.654)
Total score, Week 5 change (N=102, 96)	-4.17 (5.632)	-2.37 (5.035)
Total score, Week 8 change (N=98, 93)	-4.57 (5.117)	-2.53 (5.308)

9. Secondary Outcome

Title	Baseline Pain Visual Analogue Scale (VAS) and Present Pain Intensity (PPI) Scale
Description	The VAS was part of the Short Form McGill Pain Questionnaire (SF-MPQ) scale and reflected the overall pain intensity score, The pain VAS was a horizontal line; 100 millimeters (mm) in length, was self-administered by the participant in order to rate pain from 0 (no pain) to 100 (worst possible pain). The PPI was part of the SF-MPQ scale and measured the participant's present pain intensity on a 6-point scale ranging from 0 (no pain) to 5 (excruciating).
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

The FAS population consisted of all participants randomized to treatment that received at least 1 dose of study medication. The LOCF method was used in the analysis of this outcome measure. Number of participants evaluable for PPI=110, 108

Arm/Group Title	Pregabalin	Placebo
Arm/Group Description	Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).	Participants received matching placebo capsule(s) for a period of 10 weeks
Measure Participants	111	109
VAS	60.39 (13.064)	62.60 (12.252)
PPI	2.33 (0.940)	2.42 (0.738)

10. Secondary Outcome

Title	Change From Baseline in Pain VAS From the SF-MPQ at Endpoint
Description	The VAS was part of the SF-MPQ scale and reflected the overall pain intensity score. The pain VAS was a horizontal line; 100 mm in length, was self-administered by the participant in order to rate pain from 0 (no pain) to 100 (worst possible pain).
Time Frame	Baseline to Day 57 (Week 8)/Early Termination (Study Endpoint)

Outcome Measure Data

Analysis Population Description

All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.

Arm/Group Title	Pregabalin	Placebo
Arm/Group Description	Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).	Participants received matching placebo capsule(s) for a period of 10 weeks
Measure Participants	110	106
Least Squares Mean (Standard Error) [units on a scale]	-20.71 (1.412)	-12.53 (1.451)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Analysis performed using a general linear model with treatment and center as factors, and baseline value as a covariate.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Analysis was two-sided and performed at the 0.05 significance level.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-8.18
	Confidence Interval	(2-Sided) 95%; -11.99 to -4.37
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.932
	Estimation Comments

11. Secondary Outcome

Title	Change From Baseline in PPI Scale From the SF-MPQ at Endpoint
Description	The PPI was part of the SF-MPQ scale and measured the participant's present pain intensity on a 6-point scale ranging from 0 (no pain) to 5 (excruciating).
Time Frame	Baseline to Day 57 (Week 8)/Early Termination (Study Endpoint)

Outcome Measure Data

Analysis Population Description

All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.

Arm/Group Title	Pregabalin	Placebo
Arm/Group Description	Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).	Participants received matching placebo capsule(s) for a period of 10 weeks
Measure Participants	110	105
Least Squares Mean (Standard Error) [units on a scale]	-0.79 (0.078)	-0.42 (0.080)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Analysis performed using a general linear model with treatment and center as factors, and baseline value as a covariate.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.0007
	Comments	Analysis was two-sided and performed at the 0.05 significance level.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.37
	Confidence Interval	(2-Sided) 95%; -0.58 to -0.16
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.107
	Estimation Comments

12. Secondary Outcome

Title	Baseline Medical Outcomes Study (MOS)-Sleep Scale Scores
Description	The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. With the exception of sleep adequacy, optimal sleep, and quantity, higher scores reflected greater impairment in the MOS-Sleep subscales. The MOS-Sleep Scale was used to evaluate sleep during the previous week.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

The FAS population consisted of all participants randomized to treatment that received at least 1 dose of study medication. The LOCF method was used in the analysis of this outcome measure.

Arm/Group Title	Pregabalin	Placebo
Arm/Group Description	Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).	Participants received matching placebo capsule(s) for a period of 10 weeks
Measure Participants	111	109
Sleep disturbance score	36.09 (25.542)	35.08 (22.365)
Snoring score	29.19 (32.450)	30.83 (35.017)
Awaken short of breath score	9.91 (21.213)	8.07 (18.282)
Quantity of sleep score	6.05 (1.534)	5.97 (1.524)
Sleep adequacy score	57.66 (31.449)	60.46 (29.008)
Somnolence score	32.25 (19.950)	30.89 (17.816)
Sleep problems index score	31.38 (20.691)	29.27 (17.292)

13. Secondary Outcome

Title	Change From Baseline in MOS-Sleep Scale, Sleep Disturbance Score at Endpoint
Description	The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. For sleep disturbance, the subscale score also ranged from 0 to 100, with higher scores representing greater sleep disturbance.
Time Frame	Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)

Outcome Measure Data

Analysis Population Description

All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure.

Arm/Group Title	Pregabalin	Placebo
Arm/Group Description	Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).	Participants received matching placebo capsule(s) for a period of 10 weeks
Measure Participants	103	97
Least Squares Mean (Standard Error) [units on a scale]	-11.97 (1.821)	-4.76 (1.871)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Analysis performed using a general linear model with treatment and center as factors, and baseline value as a covariate.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.0039
	Comments	Analysis was two-sided and performed at the 0.05 significance level.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-7.21
	Confidence Interval	(2-Sided) 95%; -12.08 to -2.35
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.464
	Estimation Comments

14. Secondary Outcome

Title	Change From Baseline in MOS-Sleep Scale, Snoring Score at Endpoint
Description	The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The snoring subscale score also ranged from 0 to 100, with lower scores indicating less snoring.
Time Frame	Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)

Outcome Measure Data

Analysis Population Description

All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure.

Arm/Group Title	Pregabalin	Placebo
Arm/Group Description	Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).	Participants received matching placebo capsule(s) for a period of 10 weeks
Measure Participants	104	97
Least Squares Mean (Standard Error) [units on a scale]	-2.00 (2.043)	-3.73 (2.131)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Analysis performed using a general linear model with treatment and center as factors, and baseline value as a covariate.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.5351
	Comments	Analysis was two-sided and performed at the 0.05 significance level.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	1.73
	Confidence Interval	(2-Sided) 95%; -3.76 to 7.22
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.783
	Estimation Comments

15. Secondary Outcome

Title	Change From Baseline in MOS-Sleep Scale, Awaken Short of Breath Score at Endpoint
Description	The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The awaken short of breath subscale also ranged from 0 to 100, with lower scores indicating less difficulty in breathing.
Time Frame	Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)

Outcome Measure Data

Analysis Population Description

All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure.

Arm/Group Title	Pregabalin	Placebo
Arm/Group Description	Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).	Participants received matching placebo capsule(s) for a period of 10 weeks
Measure Participants	104	96
Least Squares Mean (Standard Error) [units on a scale]	-0.10 (1.895)	0.26 (1.988)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Analysis performed using a general linear model with treatment and center as factors, and baseline value as a covariate.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.8892
	Comments	Analysis was two-sided and performed at the 0.05 significance level.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.36
	Confidence Interval	(2-Sided) 95%; -5.45 to 4.73
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.579
	Estimation Comments

16. Secondary Outcome

Title	Change From Baseline in MOS-Sleep Scale, Quantity of Sleep Score at Endpoint
Description	The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The MOS Sleep Quantity sub-scale scores ranged from 0 to 24 (number of hours slept).
Time Frame	Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)

Outcome Measure Data

Analysis Population Description

All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure.

Arm/Group Title	Pregabalin	Placebo
Arm/Group Description	Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).	Participants received matching placebo capsule(s) for a period of 10 weeks
Measure Participants	101	96
Least Squares Mean (Standard Error) [units on a scale]	0.69 (0.108)	0.25 (0.111)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Analysis performed using a general linear model with treatment and center as factors, and baseline value as a covariate.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.0035
	Comments	Analysis was two-sided and performed at the 0.05 significance level.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	0.43
	Confidence Interval	(2-Sided) 95%; 0.14 to 0.72
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.147
	Estimation Comments

17. Secondary Outcome

Title	Percentage of Participants Who Had Optimal Sleep at Endpoint
Description	The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The MOS optimal sleep subscale was a binary outcome derived from the sleep quantity responses: the response was YES if sleep quantity was 7 or 8 hours per night.
Time Frame	Day 57 (Week 8)/Early Termination (Study Endpoint)

Outcome Measure Data

Analysis Population Description

All participants in the FAS population (consisted of all participants randomized to treatment that received at least 1 dose of study medication) with available data to contribute to the analysis.

Arm/Group Title	Pregabalin	Placebo
Arm/Group Description	Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).	Participants received matching placebo capsule(s) for a period of 10 weeks
Measure Participants	101	96
Number [percentage of participants]	49.5 44.6%	40.6 37.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Analysis performed using a logistic regression model with treatment and center as factors, and baseline value as a covariate.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.0972
	Comments	Analysis was two-sided and performed at the 0.05 significance level.
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.80
	Confidence Interval	(2-Sided) 95%; 0.90 to 3.60
	Parameter Dispersion	Type: Value:
	Estimation Comments

18. Secondary Outcome

Title	Change From Baseline in MOS-Sleep Scale, Sleep Adequacy Score at Endpoint
Description	The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The sleep adequacy subscale also ranged from 0 to 100, with higher scores indicating greater sleep adequacy.
Time Frame	Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)

Outcome Measure Data

Analysis Population Description

All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure.

Arm/Group Title	Pregabalin	Placebo
Arm/Group Description	Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).	Participants received matching placebo capsule(s) for a period of 10 weeks
Measure Participants	103	97
Least Squares Mean (Standard Error) [units on a scale]	10.44 (2.325)	8.64 (2.403)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Analysis performed using a general linear model with treatment and center as factors, and baseline value as a covariate.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.5702
	Comments	Analysis was two-sided and performed at the 0.05 significance level.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	1.80
	Confidence Interval	(2-Sided) 95%; -4.44 to 8.03
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 3.161
	Estimation Comments

19. Secondary Outcome

Title	Change From Baseline in MOS-Sleep Scale, Somnolence Score at Endpoint
Description	The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The somnolence subscale score also ranged from 0 to 100, with lower scores indicating less somnolence.
Time Frame	Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)

Outcome Measure Data

Analysis Population Description

All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure.

Arm/Group Title	Pregabalin	Placebo
Arm/Group Description	Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).	Participants received matching placebo capsule(s) for a period of 10 weeks
Measure Participants	104	97
Least Squares Mean (Standard Error) [units on a scale]	0.33 (1.613)	-0.54 (1.668)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Analysis performed using a general linear model with treatment and center as factors, and baseline value as a covariate.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.6929
	Comments	Analysis was two-sided and performed at the 0.05 significance level.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	0.87
	Confidence Interval	(2-Sided) 95%; -3.46 to 5.20
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.194
	Estimation Comments

20. Secondary Outcome

Title	Change From Baseline in MOS-Sleep Scale, Sleep Problems Index Score at Endpoint
Description	The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The sleep problems index subscale score also ranged from 0 to 100, with lower scores indicating fewer sleep problems.
Time Frame	Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)

Outcome Measure Data

Analysis Population Description

All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure.

Arm/Group Title	Pregabalin	Placebo
Arm/Group Description	Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).	Participants received matching placebo capsule(s) for a period of 10 weeks
Measure Participants	102	96
Least Squares Mean (Standard Error) [units on a scale]	-7.38 (1.427)	-4.54 (1.471)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Analysis performed using a general linear model with treatment and center as factors, and baseline value as a covariate.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.1403
	Comments	Analysis was two-sided and performed at the 0.05 significance level.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-2.84
	Confidence Interval	(2-Sided) 95%; -6.63 to 0.94
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.920
	Estimation Comments

21. Secondary Outcome

Title	Clinical Global Impression of Change (CGIC) Score at Endpoint
Description	The CGIC was a clinician-rated global measure that provided a clinically relevant and easy to interpret account of a clinician's perception of the clinical importance of the participant's improvement or worsening during their involvement in a clinical study. Clinicians rated the participant's overall improvement on a 7-point scale where scores ranged from 1 (very much improved) to 7 (very much worse).
Time Frame	Day 57 (Week 8)/Early Termination (Study Endpoint)

Outcome Measure Data

Analysis Population Description

All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure.

Arm/Group Title	Pregabalin	Placebo
Arm/Group Description	Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).	Participants received matching placebo capsule(s) for a period of 10 weeks
Measure Participants	104	97
Least Squares Mean (Standard Error) [units on a scale]	2.55 (0.086)	3.18 (0.090)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Analysis was performed using a general linear model with treatment and center as factors.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Analysis was two-sided and performed at the 0.05 significance level.
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.62
	Confidence Interval	(2-Sided) 95%; -0.86 to -0.39
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.118
	Estimation Comments

22. Secondary Outcome

Title	Patient Global Impression of Change (PGIC) Score at Endpoint
Description	The PGIC was a participant-rated global measure that provided a clinically relevant and easy to interpret account of a participant's perception of the clinical importance of their own improvement or worsening during their involvement in a clinical study. Participants rated their overall improvement on a 7-point scale where scores ranged from 1 (very much improved) to 7 (very much worse).
Time Frame	Day 57 (Week 8)/Early Termination (Study Endpoint)

Outcome Measure Data

Analysis Population Description

All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure.

Arm/Group Title	Pregabalin	Placebo
Arm/Group Description	Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).	Participants received matching placebo capsule(s) for a period of 10 weeks
Measure Participants	104	97
Least Squares Mean (Standard Error) [units on a scale]	2.68 (0.083)	3.17 (0.086)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Analysis was performed using a general linear model with treatment and center as factors.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Analysis was two-sided and performed at the 0.05 significance level.
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.49
	Confidence Interval	(2-Sided) 95%; -0.72 to -0.27
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.113
	Estimation Comments

23. Secondary Outcome

Title	Baseline Hospital Anxiety and Depression Scale (HADS) Scores
Description	The HADS was a self-administered questionnaire that consisted of 2 subscales, 1 measuring anxiety (HADS-A Scale) and the other measuring depression (HADS-D Scale). Each subscale comprised of 7 items; participants assessed how each item applied to them on a scale of 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Subscores from HADS-A (Anxiety) and HADS-D (Depression) were not to be combined. The interpretation of each HADS subscales was as follows: 0-7 normal, 8-10 mild, 11-14 moderate and 15-21 severe.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.

Arm/Group Title	Pregabalin	Placebo
Arm/Group Description	Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).	Participants received matching placebo capsule(s) for a period of 10 weeks
Measure Participants	111	109
Anxiety total score	3.22 (3.921)	3.37 (3.466)
Depression total score	3.45 (3.963)	3.47 (3.387)

24. Secondary Outcome

Title	Change From Baseline in HADS Anxiety Total Score at Endpoint
Description	The HADS was a self-administered questionnaire that consisted of 2 subscales, 1 measuring anxiety (HADS-A Scale) and the other measuring depression (HADS-D Scale). Each subscale was comprised of 7 items; participants assessed how each item applied to them on a scale of 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Subscores from HADS-A (Anxiety) and HADS-D (Depression) were not to be combined. The interpretation of each HADS subscales was as follows: 0-7 normal, 8-10 mild, 11-14 moderate and 15-21 severe.
Time Frame	Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)

Outcome Measure Data

Analysis Population Description

All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure.

Arm/Group Title	Pregabalin	Placebo
Arm/Group Description	Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).	Participants received matching placebo capsule(s) for a period of 10 weeks
Measure Participants	104	97
Least Squares Mean (Standard Error) [units on a scale]	-0.92 (0.233)	-0.71 (0.241)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Analysis was performed using a general linear model with treatment and center as factors, and the baseline value as a covariate.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.5060
	Comments	Analysis was two-sided and performed at the 0.05 significance level.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.21
	Confidence Interval	(2-Sided) 95%; -0.83 to 0.41
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.315
	Estimation Comments

25. Secondary Outcome

Title	Change From Baseline in HADS Depression Total Score at Endpoint
Description	The HADS was a self-administered questionnaire that consisted of 2 subscales, 1 measuring anxiety (HADS-A Scale) and the other measuring depression (HADS-D Scale). Each subscale was comprised of 7 items; participants assessed how each item applied to them on a scale of 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Subscores from HADS-A (Anxiety) and HADS-D (Depression) were not to be combined. The interpretation of each HADS subscales was as follows: 0-7 normal, 8-10 mild, 11-14 moderate and 15-21 severe.
Time Frame	Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)

Outcome Measure Data

Analysis Population Description

All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure.

Arm/Group Title	Pregabalin	Placebo
Arm/Group Description	Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).	Participants received matching placebo capsule(s) for a period of 10 weeks
Measure Participants	104	97
Least Squares Mean (Standard Error) [units on a scale]	-0.65 (0.209)	-0.55 (0.217)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pregabalin, Placebo
	Comments	Analysis was performed using a general linear model with treatment and center as factors, and the baseline value as a covariate.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.7247
	Comments	Analysis was two-sided and performed at the 0.05 significance level.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.10
	Confidence Interval	(2-Sided) 95%; -0.66 to 0.46
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.285
	Estimation Comments

Adverse Events

Adverse Event Reporting Description	The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another, or one participant may have experienced both a serious and nonserious event during the study. All treated participants were included in the analysis.
Arm/Group Title	Pregabalin		Placebo
Arm/Group Description	Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).		Participants received matching placebo capsule(s) for a period of 10 weeks.
All Cause Mortality
	Pregabalin		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Pregabalin		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/111 (1.8%)		0/109 (0%)
Infections and infestations
Respiratory tract infection	1/111 (0.9%)		0/109 (0%)
Nervous system disorders
Cerebral ischaemia	1/111 (0.9%)		0/109 (0%)
Other (Not Including Serious) Adverse Events
	Pregabalin		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	40/111 (36%)		21/109 (19.3%)
Gastrointestinal disorders
Dry mouth	6/111 (5.4%)		3/109 (2.8%)
General disorders
Oedema peripheral	7/111 (6.3%)		2/109 (1.8%)
Infections and infestations
Nasopharyngitis	5/111 (4.5%)		9/109 (8.3%)
Nervous system disorders
Dizziness	27/111 (24.3%)		4/109 (3.7%)
Somnolence	6/111 (5.4%)		5/109 (4.6%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.