Pregabalin Peripheral Neuropathic Pain Study

DPRS is 11-point rating scale from 0 (no pain) to 10 (worst possible pain). Subjects instructed to describe their pain (daily upon awakening) during preceding 24 hrs by choosing the appropriate number between 0-10. Mean endpoint pain score was obtained from the last 7 available DPRS scores of the daily pain diary while subject on study medication.

Time frame: Endpoint- Week 8 or Early Discontinuation

Population: The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. For subjects who did not complete the study, the last 7 available daily pain scores while on study medication were carried forward (LOCF) to calculate the endpoint mean score.

CGIC is a clinician-rated instrument that assesses the subject's overall global improvement on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improved = minimally improved, much improved, and very much improved; Worse = minimally worse, much worse, and very much worse.

Time frame: Week 8

Population: The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. CGIC was measured at Week 8. For subjects not completing the study, their final data were considered Week 8 data; those without final data were excluded from analysis.

DPRS consists of an 11-point rating scale ranging from 0 (no pain) to 10 (worst possible pain). A 30% responder at endpoint is a subject who has a 30% or more reduction in mean pain score at endpoint compared to baseline

Time frame: Endpoint- Week 8 or Early Discontinuation

Population: The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. For subjects who did not complete the study, the last 7 available daily pain scores while on study medication were carried forward (LOCF) to calculate the endpoint mean score.

DPRS consists of an 11-point rating scale ranging from 0 (no pain) to 10 (worst possible pain). A 50% responder at endpoint is a subject who has a 50% or more reduction in mean pain score at endpoint compared to baseline.

Time frame: Endpoint- Week 8 or Early Discontination

Population: The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. For subjects who did not complete the study, the last 7 available daily pain scores while on study medication were carried forward (LOCF) to calculate the endpoint mean score.

DPRS is 11-point rating scale (0=no pain to 10=worst possible pain). Subjects instructed to describe pain (upon awakening) during preceding 24 hrs by choosing appropriate number between 0-10. Mean endpoint pain score obtained from last 7 available DPRS scores of daily pain diary while subject on study medication. Overall Comparison=8-week average.

Time frame: Weeks 1 to 8

Population: The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. Missing Weekly mean scores were not imputed. Number of subjects analyzed differed by week; noted as n= (pregabalin, placebo).

DAAC is a score used to assess treatment effects averaged over the entire length of the study. DAAC from baseline to weekly mean pain score was derived by calculating the mean of all post-baseline scores minus baseline mean pain score, and then weighing this according to the proportion of the planned study duration the subject actually completed.

Time frame: Weeks 1 to 8

Population: The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. Subjects without any post-baseline daily pain scores would have no DAAC; missing DAACs were not imputed.

DAAC is a score used to assess treatment effects averaged over the entire length of the study. DAAC from baseline to weekly mean pain score was derived by calculating the mean of all post-baseline scores minus baseline mean pain score, and then weighing this according to the proportion of the planned study duration the subject actually completed.

Time frame: Weeks 1 to 8

Population: The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. For subjects who did not complete the study, the last 7 observations while on study medication were carried forward (LOCF).

EQ-5D is a subject-completed questionnaire to assess health-related QOL (Health State Profile (HSP) & Visual Analog Scale (VAS)). The VAS is designed to rate the subject's current health state on a scale from 0 to 100 where 0 represents the worst imaginable health state and 100 represents the best imaginable health state.

Time frame: Week 8

Population: The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. EQ-5D was measured at baseline and Week 8. For subjects not completing the study, their final data were considered Week 8 data; those without final data were excluded from analysis.

EQ-5D, a subject-completed questionnaire, assesses health-related QOL. QOL Health State Profile (HSP) is designed to record subject's level of current health across 5 domains (mobility, self-care, usual activities, pain/discomfort & anxiety/depression); scores are used to calculate EQ-5D Utility Score; range: -0.594 to 1.000 (from worst to best).

Time frame: Week 8

Population: The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. EQ-5D was measured at baseline and Week 8. For subjects not completing the study, their final data were considered Week 8 data; those without final data were excluded from analysis.

HADS-A consists of 7 items that are assessed by a score of 0 = no anxiety to 3 = severe feeling of anxiety. The anxiety subscale determines a state of generalized anxiety (including anxious mood, restlessness, anxious thoughts, panic attacks). Score range = 0 to 21; higher scores indicate a greater intensity of anxiety

Time frame: Week 8

Population: The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. HADS was measured at baseline and Week 8. For subjects not completing the study, their final data were considered Week 8 data; those without final data were excluded from analysis.

HADS-D consists of 7 items that are assessed by a score of 0 = no depression to 3 = severe feeling of depression. The depression subscale focuses on the state of lost interest and diminished pleasure response (lowering of hedonic tone). Score range = 0 to 21; higher scores indicate a greater intensity of depression

Time frame: Week 8

Population: The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. HADS was measured at baseline and Week 8. For subjects not completing the study, their final data were considered Week 8 data; those without final data were excluded from analysis.

DSIS consists of an 11-point rating scale (0 = pain did not interfere with sleep to 10 = completely interfered with sleep). Higher score indicating greater level of sleep disturbance.

Time frame: Endpoint- Week 8 or Early Discontinuation

Population: The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. For subjects who did not complete the study, the last 7 available daily sleep interference scores while on study medication were carried forward (LOCF) to calculate the endpoint mean score.

DSIS consists of an 11-point rating scale ranging from 0 = pain did not interfere with sleep to 10 = pain completely interfered with sleep. Overall Comparison= 8-week average.

Time frame: Weeks 1 to 8

Population: ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. Missing Weekly mean scores were not imputed. Number of subjects analyzed differed by week; noted as n = (pregabalin, placebo).

MOS Sleep Scale is a subject-rated questionnaire consisting of 12 items that assess the key constructs of sleep; assesses sleep for the 4 weeks prior to evaluation. The MOS Awaken Short of Breath or with a Headache sub-scale scores range from 0 to 100, lower scores indicate less difficulty.

Time frame: Week 8

Population: The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. MOS was measured at baseline and Week 8. For subjects not completing the study, their final data were considered Week 8 data; those without final data were excluded from the analysis.

MOS Sleep Scale is a subject-rated questionnaire consisting of 12 items that assess the key constructs of sleep; assesses sleep for the 4 weeks prior to evaluation. The MOS Optimal Sleep sub-scale score is a binary outcome derived from Sleep Quantity (SQ): the response is YES (or 1) if SQ = 7 or 8 hours per night.

Time frame: Week 8

Population: The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. MOS was measured at baseline and Week 8. For subjects not completing the study, their final data were considered Week 8 data; those without final data were excluded from the analysis.

MOS Sleep Scale is a subject-rated questionnaire consisting of 12 items that assess the key constructs of sleep; assesses sleep for the 4 weeks prior to evaluation. The MOS Overall Sleep Problems Index is a 9-item sub-scale; scores range from 0 to 100, lower scores indicate fewer sleep problems.

Time frame: Week 8

Population: The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. MOS was measured at baseline and Week 8. For subjects not completing the study, their final data were considered Week 8 data; those without final data were excluded from the analysis.

MOS Sleep Scale is a subject-rated questionnaire consisting of 12 items that assess the key constructs of sleep; assesses sleep for the 4 weeks prior to evaluation. The MOS Sleep Adequacy sub-scale scores range from 0 to 100, higher scores indicate greater sleep adequacy.

Time frame: Week 8

Population: The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. MOS was measured at baseline and Week 8. For subjects not completing the study, their final data were considered Week 8 data; those without final data were excluded from the analysis.

MOS Sleep Scale is a subject-rated questionnaire consisting of 12 items that assess the key constructs of sleep; assesses sleep for the 4 weeks prior to evaluation. The MOS Sleep Disturbance sub-scale scores range from 0 to 100, lower scores indicate less disturbance.

Time frame: Week 8

Population: The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. MOS was measured at baseline and Week 8. For subjects not completing the study, their final data were considered Week 8 data; those without final data were excluded from analysis.

MOS Sleep Scale is a subject-rated questionnaire consisting of 12 items that assess the key constructs of sleep; assesses sleep for the 4 weeks prior to evaluation. The MOS Sleep Quantity sub-scale scores range from 0 to 24 (number of hours slept).

Time frame: Week 8

Population: The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. MOS was measured at baseline and Week 8. For subjects not completing the study, their final data were considered Week 8 data; those without final data were excluded from the analysis.

MOS Sleep Scale is a subject-rated questionnaire consisting of 12 items that assess the key constructs of sleep; assesses sleep for the 4 weeks prior to evaluation. The MOS Snoring sub-scale scores range from 0 to 100, lower scores indicate less snoring.

Time frame: Week 8

Population: The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. MOS was measured at baseline and Week 8. For subjects not completing the study, their final data were considered Week 8 data; those without final data were excluded from analysis.

MOS Sleep Scale is a subject-rated questionnaire consisting of 12 items that assess the key constructs of sleep; assesses sleep for the 4 weeks prior to evaluation. The MOS Somnolence sub-scale scores range from 0 to 100, lower scores indicate less somnolence.

Time frame: Week 8

Population: The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. MOS was measured at baseline and Week 8. For subjects not completing the study, their final data were considered Week 8 data; those without final data were excluded from the analysis.

PGIC is a subject-rated instrument that measured change in subject's overall status on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improved = minimally improved, much improved, and very much improved; Worse = minimally worse, much worse, and very much worse.

Time frame: Week 8

Population: The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. PGIC was measured at Week 8. For subjects not completing the study, their final data were considered Week 8 data; those without final data were excluded from analysis.

DPRS is 11-point rating scale from 0 (no pain) to 10 (worst possible pain). Subjects instructed to describe their pain (daily upon awakening) during preceding 24 hrs by choosing the appropriate number between 0-10. Mean endpoint pain score was obtained from the last 7 available DPRS scores of the daily pain diary while subject on study medication.

Time frame: Endpoint- Week 8 or Early Discontinuation

Population: Evaluable (EVAL) Population: Subset of ITT subjects with ≥4 daily pain diaries in the 7 days before Visit 2 (randomization) with average score ≥4; ≥14 days of treatment; ≥14 days of DB daily pain diaries; not withdrawn due to Protocol violation or Did not meet entrance criteria; not previously participated in the study.