A 13-Week, Randomized, Double-Blind, Multicenter, Placebo... | NCT00394901

Label	Type	Intervention Names
Placebo	Placebo Comparator	Drug: Placebo
Pregabalin 150mg/day	Experimental	Drug: Pregabalin
Pregabalin 300mg/day	Experimental	Drug: Pregabalin
Pregabalin 600mg/day	Experimental	Drug: Pregabalin

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Drug	placebo, oral administration for 13 weeks (1 week titration and 12-week fixed dose).	Placebo

Measure	Description	Time Frame
Mean Pain Scores at Endpoint	Endpoint mean pain score is defined as the mean of the last 7 daily pain diary rating while taking the study medication, up to and including day after last dose. Scores range from 0-10 (11 points ordinal) with higher scores indicating increased pain.	Week13/discontinuation
Mean Pain Score at Endpoint by Groups of Subjects With Expected Similar Plasma Concentrations	Endpoint mean pain score is defined as the mean of the last 7 daily pain diary rating while taking the study medication, up to and including day after last dose. Scores range from 0-10 (11 points ordinal) with higher scores indicating increased pain.	Week13/discontinuation
Number of Responders	A responder is defined as a subject with a 50% reduction in weekly mean pain score from baseline to endpoint.	Week13/discontinuation
Mean Pain Scores at Week 1	Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.	Week 1
Mean Pain Scores at Week 2	Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.	Week 2
Mean Pain Scores at Week 3	Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.

Measure	Description	Time Frame
Endpoint Sensory Scores of the Short-Form McGill Pain Questionnaire	Sensory score range from 0-33. Higher scores indicate more severe pain.	Week13/discontinuation
Endpoint Affective Scores of the Short-Form McGill Pain Questionnaire

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Nagoya	Aichi-ken		Japan
Pfizer Investigational Site

Label	URL
To obtain contact information for a study center near you, click here.	View source

ID	Title	Description
FG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
FG001	Pregabalin 150 mg/Day	During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Mean Pain Scores at Endpoint

Endpoint mean pain score is defined as the mean of the last 7 daily pain diary rating while taking the study medication, up to and including day after last dose. Scores range from 0-10 (11 points ordinal) with higher scores indicating increased pain.

Full analysis set. Last observation carried forward.

Posted

Least Squares Mean

Standard Error

score on scale

Week13/discontinuation

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Pregabalin 150 mg/Day	During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
OG002	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
OG003	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

Units	Counts
Participants	OG00097 OG00186 OG00289 OG003

Title

Denominators

Categories

Title	Measurements
	OG0005.12± 0.19 OG0014.81± 0.20 OG0024.26± 0.20 OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Hypothesis testing was conducted using two-sided tests with significance level of 0.05.	ANCOVA	The model included treatment and CLcr stratum as factors, and baseline score as covariate.	0.262		Mean Difference (Final Values)	-0.31				95	-0.85	0.23					Superiority or Other (legacy)
OG000 OG002

Primary

Mean Pain Score at Endpoint by Groups of Subjects With Expected Similar Plasma Concentrations

Full analysis set. Last observation carried forward.

Posted

Least Squares Mean

Standard Error

score on scale

Week13/discontinuation

ID	Title	Description
OG000	Placebo	Subjects who received matching placebo during a 13-week double-blind treatment phase.
OG001	Expected Pregabalin Exposure of 300 mg/Day	Subjects with low CLcr (> 30 and <= 60 mL/min) who received pregabalin 150 mg/day and subjects with normal CLcr (> 60 mL/min) who received pregabalin 300 mg/day.
OG002	Expected Pregabalin Exposure of 600 mg/Day	Subjects with low CLcr (> 30 and <= 60 mL/min) who received pregabalin 300 mg/day and subjects who received pregabalin 600 mg/day.

Primary

Number of Responders

A responder is defined as a subject with a 50% reduction in weekly mean pain score from baseline to endpoint.

Full analysis set. Last observation carried forward.

Posted

Number

participants

Week13/discontinuation

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Pregabalin 150 mg/Day	During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
OG002	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
OG003	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

Primary

Mean Pain Scores at Week 1

Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.

Full analysis set. Observed case.

Posted

Least Squares Mean

Standard Error

score on scale

Week 1

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Pregabalin 150 mg/Day	During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
OG002	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
OG003	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

Primary

Mean Pain Scores at Week 2

Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.

Full analysis set. Observed case.

Posted

Least Squares Mean

Standard Error

score on scale

Week 2

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Pregabalin 150 mg/Day	During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
OG002	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
OG003	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

Primary

Mean Pain Scores at Week 3

Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.

Full analysis set. Observed case.

Posted

Least Squares Mean

Standard Error

score on scale

Week 3

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Pregabalin 150 mg/Day	During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
OG002	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
OG003	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

Secondary

Endpoint Sensory Scores of the Short-Form McGill Pain Questionnaire

Sensory score range from 0-33. Higher scores indicate more severe pain.

Full analysis set. Last observation carried forward.

Posted

Least Squares Mean

Standard Error

score on scale

Week13/discontinuation

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Pregabalin 150 mg/Day	During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
OG002	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
OG003	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

Secondary

Endpoint Affective Scores of the Short-Form McGill Pain Questionnaire

Affective score range from 0-12. Higher scores indicate more severe pain.

Full analysis set. Last observation carried forward.

Posted

Least Squares Mean

Standard Error

score on scale

Week13/discontinuation

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Pregabalin 150 mg/Day	During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
OG002	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
OG003	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

Secondary

Endpoint Total Scores of the Short-Form McGill Pain Questionnaire

Total score range from 0-45. Higher scores indicate more severe pain.

Full analysis set. Last observation carried forward

Posted

Least Squares Mean

Standard Error

score on scale

Week13/discontinuation

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Pregabalin 150 mg/Day	During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
OG002	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
OG003	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

Secondary

Endpoint Visual Analogue Scale Scores of the Short-Form McGill Pain Questionnaire

Visual Analogue Scale Score range from 0-100mm. Higher scores indicate more severe pain.

Full analysis set. Last observation carried forward.

Posted

Least Squares Mean

Standard Error

Week13/discontinuation

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Pregabalin 150 mg/Day	During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
OG002	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
OG003	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

Secondary

Endpoint Present Pain Intensity Scores of the Short-Form McGill Pain Questionnaire

Present pain intensity score range from 0-5. Higher scores indicate more severe pain.

Full analysis set. Last observation carried forward.

Posted

Least Squares Mean

Standard Error

score on scale

Week13/discontinuation

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Pregabalin 150 mg/Day	During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
OG002	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
OG003	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

Secondary

Mean Sleep Interference Scores at Endpoint

Scores range from 0-10. Higher scores indicate more severe interference with sleep.

Full analysis set. Last observation carried forward.

Posted

Least Squares Mean

Standard Error

score on scale

Week13/discontinuation

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Pregabalin 150 mg/Day	During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
OG002	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
OG003	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

Secondary

Endpoint Medical Outcomes Study Sleep Scale Scores:Sleep Disturbance

Score range for sleep disturbance is 0-100.Higher scores indicate more of the attribute.

Full analysis set. Last observation carried forward.

Posted

Least Squares Mean

Standard Error

score on scale

Week13/discontinuation

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Pregabalin 150 mg/Day	During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
OG002	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
OG003	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

Secondary

Endpoint Medical Outcomes Study Sleep Scale Scores:Snoring

Score range for snoring is 0-100.Higher scores indicate more of the attribute.

Full analysis set. Last observation carried forward.

Posted

Least Squares Mean

Standard Error

score on scale

Week13/discontinuation

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Pregabalin 150 mg/Day	During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
OG002	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
OG003	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

Secondary

Endpoint Medical Outcomes Study Sleep Scale Scores:Awaken Short of Breath or With Headache

Score range for awaken short of breath or with headache is 0-100. Higher scores indicate more of the attribute.

Full analysis set. Last observation carried forward.

Posted

Least Squares Mean

Standard Error

score on scale

Week13/discontinuation

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Pregabalin 150 mg/Day	During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
OG002	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
OG003	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

Secondary

Endpoint Medical Outcomes Study Sleep Scale Scores:Quantity of Sleep

Sleep Quantity subscale is scored from 0-24 indicating the number of hours of sleep. Higher scores indicate more of the attribute named in the subscale.

Full analysis set. Last observation carried forward.

Posted

Least Squares Mean

Standard Error

score on scale

Week13/discontinuation

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Pregabalin 150 mg/Day	During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
OG002	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
OG003	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

Secondary

Endpoint Medical Outcomes Study Sleep Scale Scores:Sleep Adequacy

Score range for sleep adequacy is 0-100. Higher scores indicate more of the attribute.

Full analysis set. Last observation carried forward.

Posted

Least Squares Mean

Standard Error

score on scale

Week13/discontinuation

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Pregabalin 150 mg/Day	During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
OG002	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
OG003	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

Secondary

Endpoint Medical Outcomes Study Sleep Scale Scores:Somnolence

Score range for Somnolence is 0-100. Higher scores indicate more of the attribute.

Full analysis set. Last observation carried forward.

Posted

Least Squares Mean

Standard Error

score on scale

Week13/discontinuation

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Pregabalin 150 mg/Day	During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
OG002	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
OG003	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

Secondary

Endpoint Medical Outcomes Study Sleep Scale Scores:Overall Sleep Problem Index

Score range for overall sleep problem index is 0-100. Higher scores indicate more of the attribute.

Full analysis set. Last observation carried forward.

Posted

Least Squares Mean

Standard Error

score on scale

Week13/discontinuation

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Pregabalin 150 mg/Day	During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
OG002	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
OG003	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

Secondary

Endpoint Medical Outcomes Study Sleep Scale: Number of Participants With Optimal Sleep

Number of participants who reported Optimal Sleep

Full analysis set. Last observation carried forward.

Posted

Number

participants

Week13/discontinuation

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Pregabalin 150 mg/Day	During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
OG002	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
OG003	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

Secondary

Endpoint Patient Global Impression Change

Patient Global Impression Change is scaled from 1 to 7. 1=very much improved, 7=very much worse.

Full analysis set. Last observation carried forward.

Posted

Mean

Standard Deviation

score on scale

Week13/discontinuation

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Pregabalin 150 mg/Day	During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
OG002	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
OG003	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

Secondary

Endpoint Clinical Global Impression Change

Clinical Global Impression Change is scaled from 1 to 7. 1=very much improved, 7=very much worse.

Full analysis set. Last observation carried forward.

Posted

Mean

Standard Deviation

score on scale

Week13/discontinuation

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Pregabalin 150 mg/Day	During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
OG002	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
OG003	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

Secondary

Endpoint Short-Form 36-Item Health Survey Scores: Physical Functioning

Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.

Full analysis set. Last observation carried forward.

Posted

Least Squares Mean

Standard Error

score on scale

Week13/discontinuation

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Pregabalin 150 mg/Day	During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
OG002	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
OG003	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

Secondary

Endpoint Short-Form 36-Item Health Survey Scores: Role Limitations-Physical

Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.

Full analysis set. Last observation carried forward.

Posted

Least Squares Mean

Standard Error

score on scale

Week13/discontinuation

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Pregabalin 150 mg/Day	During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
OG002	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
OG003	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

Secondary

Endpoint Short-Form 36-Item Health Survey Scores: Bodily Pain

Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.

Full analysis set. Last observation carried forward.

Posted

Least Squares Mean

Standard Error

score on scale

Week13/discontinuation

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Pregabalin 150 mg/Day	During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
OG002	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
OG003	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

Secondary

Endpoint Short-Form 36-Item Health Survey Scores: General Health Perception

Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.

Full analysis set. Last observation carried forward.

Posted

Least Squares Mean

Standard Error

score on scale

Week13/discontinuation

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Pregabalin 150 mg/Day	During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
OG002	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
OG003	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

Secondary

Endpoint Short-Form 36-Item Health Survey Scores: Social Functioning

Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.

Full analysis set. Last observation carried forward.

Posted

Least Squares Mean

Standard Error

score on scale

Week13/discontinuation

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Pregabalin 150 mg/Day	During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
OG002	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
OG003	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

Secondary

Endpoint Short-Form 36-Item Health Survey Scores: Role Limitations-Emotional

Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.

Full analysis set. Last observation carried forward.

Posted

Least Squares Mean

Standard Error

score on scale

Week13/discontinuation

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Pregabalin 150 mg/Day	During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
OG002	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
OG003	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

Secondary

Endpoint Short-Form 36-Item Health Survey Scores: Vitality

Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.

Full analysis set. Last observation carried forward.

Posted

Least Squares Mean

Standard Error

score on scale

Week13/discontinuation

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Pregabalin 150 mg/Day	During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
OG002	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
OG003	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

Secondary

Endpoint Short-Form 36-Item Health Survey Scores: Mental Health

Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.

Full analysis set. Last observation carried forward.

Posted

Least Squares Mean

Standard Error

score on scale

Week13/discontinuation

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Pregabalin 150 mg/Day	During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
OG002	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
OG003	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

Secondary

Number of Patients Not Reporting Allodynia

Participants not reporting allodynia.

Full analysis set. Last observation carried forward.

Posted

Number

participants

Week13/discontinuation

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Pregabalin 150 mg/Day	During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
OG002	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
OG003	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

Secondary

Number of Patients Not Reporting Hyperalgesia

Participants not reporting hyperalgesia.

Full analysis set. Last observation carried forward.

Posted

Number

participants

Week13/discontinuation

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Pregabalin 150 mg/Day	During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
OG002	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
OG003	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

Primary

Mean Pain Scores at Week 4

Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.

Full analysis set. Observed case.

Posted

Least Squares Mean

Standard Error

score on scale

Week4

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Pregabalin 150 mg/Day	During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
OG002	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
OG003	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

Primary

Mean Pain Scores at Week 5

Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.

Full analysis set. Observed case.

Posted

Least Squares Mean

Standard Error

score on scale

Week 5

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Pregabalin 150 mg/Day	During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
OG002	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
OG003	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

Primary

Mean Pain Scores at Week 6

Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.

Full analysis set. Observed case.

Posted

Least Squares Mean

Standard Error

score on scale

Week 6

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Pregabalin 150 mg/Day	During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
OG002	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
OG003	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

Primary

Mean Pain Scores at Week 7

Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.

Full analysis set. Observed case.

Posted

Least Squares Mean

Standard Error

score on scale

Week 7

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Pregabalin 150 mg/Day	During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
OG002	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
OG003	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

Primary

Mean Pain Scores at Week 8

Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.

Full analysis set. Observed case.

Posted

Least Squares Mean

Standard Error

score on scale

Week 8

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Pregabalin 150 mg/Day	During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
OG002	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
OG003	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

Primary

Mean Pain Scores at Week 9

Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.

Full analysis set. Observed case.

Posted

Least Squares Mean

Standard Error

score on scale

Week 9

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Pregabalin 150 mg/Day	During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
OG002	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
OG003	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

Primary

Mean Pain Scores at Week 10

Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.

Full analysis set. Observed case.

Posted

Least Squares Mean

Standard Error

score on scale

Week 10

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Pregabalin 150 mg/Day	During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
OG002	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
OG003	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

Primary

Mean Pain Scores at Week 11

Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.

Full analysis set. Observed case.

Posted

Least Squares Mean

Standard Error

score on scale

Week 11

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Pregabalin 150 mg/Day	During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
OG002	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
OG003	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

Primary

Mean Pain Scores at Week 12

Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.

Full analysis set. Observed case.

Posted

Least Squares Mean

Standard Error

score on scale

Week 12

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Pregabalin 150 mg/Day	During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
OG002	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
OG003	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

Primary

Mean Pain Scores at Week 13

Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.

Full analysis set. Observed case.

Posted

Least Squares Mean

Standard Error

score on scale

Week 13

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Pregabalin 150 mg/Day	During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
OG002	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
OG003	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

Secondary

Mean Sleep Interference Scores at Week 1

Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.

Full analysis set. Observed case.

Posted

Least Squares Mean

Standard Error

score on scale

week 1

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Pregabalin 150 mg/Day	During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
OG002	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
OG003	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

Secondary

Mean Sleep Interference Scores at Week 2

Full analysis set. Observed case.

Posted

Least Squares Mean

Standard Error

score on scale

week 2

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Pregabalin 150 mg/Day	During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
OG002	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
OG003	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

Secondary

Mean Sleep Interference Scores at Week 3

Full analysis set. Observed case.

Posted

Least Squares Mean

Standard Error

score on scale

week 3

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Pregabalin 150 mg/Day	During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
OG002	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
OG003	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

Secondary

Mean Sleep Interference Scores at Week 4

Full analysis set. Observed case.

Posted

Least Squares Mean

Standard Error

score on scale

week 4

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Pregabalin 150 mg/Day	During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
OG002	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
OG003	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

Secondary

Mean Sleep Interference Scores at Week 5

Full analysis set. Observed case.

Posted

Least Squares Mean

Standard Error

score on scale

week 5

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Pregabalin 150 mg/Day	During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
OG002	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
OG003	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

Secondary

Mean Sleep Interference Scores at Week 6

Full analysis set. Observed case.

Posted

Least Squares Mean

Standard Error

score on scale

week 6

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Pregabalin 150 mg/Day	During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
OG002	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
OG003	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

Secondary

Mean Sleep Interference Scores at Week 7

Full analysis set. Observed case.

Posted

Least Squares Mean

Standard Error

score on scale

week 7

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Pregabalin 150 mg/Day	During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
OG002	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
OG003	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

Secondary

Mean Sleep Interference Scores at Week 8

Full analysis set. Observed case.

Posted

Least Squares Mean

Standard Error

score on scale

week 8

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Pregabalin 150 mg/Day	During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
OG002	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
OG003	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

Secondary

Mean Sleep Interference Scores at Week 9

Full analysis set. Observed case.

Posted

Least Squares Mean

Standard Error

score on scale

week 9

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Pregabalin 150 mg/Day	During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
OG002	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
OG003	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

Secondary

Mean Sleep Interference Scores at Week 10

Full analysis set. Observed case.

Posted

Least Squares Mean

Standard Error

score on scale

week 10

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Pregabalin 150 mg/Day	During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
OG002	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
OG003	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

Secondary

Mean Sleep Interference Scores at Week 11

Full analysis set. Observed case.

Posted

Least Squares Mean

Standard Error

score on scale

week 11

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Pregabalin 150 mg/Day	During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
OG002	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
OG003	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

Secondary

Mean Sleep Interference Scores at Week 12

Full analysis set. Observed case.

Posted

Least Squares Mean

Standard Error

score on scale

week 12

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Pregabalin 150 mg/Day	During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
OG002	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
OG003	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

Secondary

Mean Sleep Interference Scores at Week 13

Full analysis set. Observed case.

Posted

Least Squares Mean

Standard Error

score on scale

week 13

ID	Title	Description
OG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
OG001	Pregabalin 150 mg/Day	During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
OG002	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
OG003	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.	6	98	35	98
EG001	Pregabalin 150 mg/Day	During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.	2	87	44	87
EG002	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.	4	89	61	89
EG003	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.	1	97	77	97

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Angina pectoris	Cardiac disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected98 at risk EG0010 affected87 at risk EG0020 affected89 at risk EG0030 affected97 at risk
Myocardial infarction	Cardiac disorders		Systematic Assessment	EG0000 affected98 at risk EG0011 affected87 at risk EG0020 affected89 at risk EG003
Large intestinal stricture	Gastrointestinal disorders		Systematic Assessment	EG0000 affected98 at risk EG0010 affected87 at risk EG0020 affected89 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders		Systematic Assessment	EG0000 affected98 at risk EG0011 affected87 at risk EG0020 affected89 at risk EG003
Subdural haematoma	Injury, poisoning and procedural complications		Systematic Assessment	EG0001 affected98 at risk EG0010 affected87 at risk EG0021 affected89 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders		Systematic Assessment	EG0000 affected98 at risk EG0010 affected87 at risk EG0021 affected89 at risk EG003
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)		Systematic Assessment	EG0001 affected98 at risk EG0010 affected87 at risk EG0020 affected89 at risk EG003
Cerebral infarction	Nervous system disorders		Systematic Assessment	EG0001 affected98 at risk EG0010 affected87 at risk EG0020 affected89 at risk EG003
Loss of consciousness	Nervous system disorders		Systematic Assessment	EG0001 affected98 at risk EG0010 affected87 at risk EG0021 affected89 at risk EG003
Completed suicide	Psychiatric disorders		Systematic Assessment	EG0001 affected98 at risk EG0010 affected87 at risk EG0020 affected89 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders		Systematic Assessment	EG0000 affected98 at risk EG0010 affected87 at risk EG0021 affected89 at risk EG003
Hypotension	Vascular disorders		Systematic Assessment	EG0000 affected98 at risk EG0010 affected87 at risk EG0021 affected89 at risk EG003

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diplopia	Eye disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected98 at risk EG0010 affected87 at risk EG0022 affected89 at risk EG0036 affected97 at risk
Constipation	Gastrointestinal disorders		Systematic Assessment	EG0006 affected98 at risk EG00112 affected87 at risk EG00211 affected89 at risk EG003
Nausea	Gastrointestinal disorders		Systematic Assessment	EG0005 affected98 at risk EG0012 affected87 at risk EG0026 affected89 at risk EG003
Face oedema	General disorders		Systematic Assessment	EG0000 affected98 at risk EG0014 affected87 at risk EG0021 affected89 at risk EG003
Oedema peripheral	General disorders		Systematic Assessment	EG0001 affected98 at risk EG0014 affected87 at risk EG00212 affected89 at risk EG003
Thirst	General disorders		Systematic Assessment	EG0003 affected98 at risk EG0013 affected87 at risk EG0027 affected89 at risk EG003
Nasopharyngitis	Infections and infestations		Systematic Assessment	EG00010 affected98 at risk EG0018 affected87 at risk EG00210 affected89 at risk EG003
Contusion	Injury, poisoning and procedural complications		Systematic Assessment	EG0002 affected98 at risk EG0015 affected87 at risk EG0024 affected89 at risk EG003
Fall	Injury, poisoning and procedural complications		Systematic Assessment	EG0004 affected98 at risk EG0016 affected87 at risk EG0027 affected89 at risk EG003
Weight increased	Investigations		Systematic Assessment	EG0000 affected98 at risk EG0011 affected87 at risk EG00217 affected89 at risk EG003
Dizziness	Nervous system disorders		Systematic Assessment	EG0007 affected98 at risk EG00110 affected87 at risk EG00227 affected89 at risk EG003
Headache	Nervous system disorders		Systematic Assessment	EG0001 affected98 at risk EG0012 affected87 at risk EG0021 affected89 at risk EG003
Somnolence	Nervous system disorders		Systematic Assessment	EG0009 affected98 at risk EG00119 affected87 at risk EG00222 affected89 at risk EG003
Eczema	Skin and subcutaneous tissue disorders		Systematic Assessment	EG0002 affected98 at risk EG0013 affected87 at risk EG0020 affected89 at risk EG003

ID	Term
D009437	Neuralgia
D010523	Peripheral Nervous System Diseases
D009468	Neuromuscular Diseases
D009422	Nervous System Diseases
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D005680	gamma-Aminobutyric Acid
D000613	Aminobutyrates
D002087	Butyrates
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals
D000596	Amino Acids
D000602	Amino Acids, Peptides, and Proteins

ID	Title	Description
BG000	Placebo	During a 13-week double-blind phase, subjects received matching placebo.
BG001	Pregabalin 150 mg/Day	During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
BG002	Pregabalin 300 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
BG003	Pregabalin 600 mg/Day	During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
BG004	Total	Total of all reporting groups