| Primary | Neuropathic Pain in Subjects With Peripheral Neuropathic Pain Conditions During the Double-blind Phase | Pain score end of Double-Blind treatment = mean of last 7 available pain scores from daily pain diary while on Double-Blind treatment. A Daily Pain Rating Score : 11- point numerical scale ranging from 0 ("no pain") to 10 ("worst possible pain"). | Full Analysis Set (FAS) = Intent-to-Treat (ITT) population, defined as all subjects who are randomized into the Double-Blind treatment phase, who receive at least one dose of Double-Blind study medication and complete at least one postrandomization efficacy assessment. | Posted | | Least Squares Mean | Standard Error | score on scale | | 9 weeks | | | | ID | Title | Description |
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| OG000 | Pregabalin | subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to pregabalin entered the double-blind phase with 35 days of dose achieved at the end of the single-blind treatment phase. | | OG001 | Placebo | subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to placebo received pregabalin 150 mg for 7 days and then placebo for 28 days. |
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| | | Title | Measurements |
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| - OG0002.84± 0.18
- OG0013.62± 0.18
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| | 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 |
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| The study is powered to detect clinically significant difference of 1.2 between treatment groups in mean pain score at end of treatment. The statistical sample size calculation requires a total of 144 subjects to complete the Double-Blind phase of the study: a sample size of 72 in each treatment group will have 90% power to detect a difference in treatment mean pain scores of 1.2 assuming that the common standard deviation is 2.2 using a two group t-test with a 0.05 two-sided significance level. | ANCOVA | | 0.0018 | | Mean Difference (Net) | -0.78 | Standard Error of the Mean | 0.25 | | 95 | -1.27 | -0.30 | | | Difference = pregabalin minus placebo | | |
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| Secondary | Weekly Mean Pain Scores During the Single-blind Treatment Phase | Pain score at Week 0 and Week 4, end of single-bind treatment. Mean of last 7 available pain scores from daily pain diary while on single-blind treatment. A Daily Pain Rating Score : 11- point numerical scale ranging from 0 ("no pain") to 10 ("worst possible pain"). | | Posted | | Mean | Standard Deviation | score on scale | | 0 and 4 weeks | | | | ID | Title | Description |
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| OG000 | Pregabalin | subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day) for ≥4 days, then dose adjustment as needed. |
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| Secondary | Weekly Mean Pain Scores During the Double Blind Treatment Phase | Mean Pain scores for weeks 4, 5, 6, 7, 8 and 9. Mean of last 7 available pain scores from daily pain diary while on single-blind treatment. A Daily Pain Rating Score : 11-point numerical scale ranging from 0 ("no pain") to 10 ("worst possible pain"). | | Posted | | Mean | Standard Deviation | score on scale | | Week 4 - 9 | | | | ID | Title | Description |
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| OG000 | Pregabalin | subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to pregabalin entered the double-blind phase with 35 days of dose achieved at the end of the single-blind treatment phase. | | OG001 | Placebo | subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to placebo received pregabalin 150 mg for 7 days and then placebo for 28 days. |
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| Secondary | Change in Pain Scores During Double Blind Treatment Phase | Change in Mean Pain score = Mean of last 7 available pain scores from daily pain diary while on single-blind treatment. A Daily Pain Rating Score : 11-point numerical scale ranging from 0 ("no pain") to 10 ("worst possible pain"). | | Posted | | Least Squares Mean | Standard Error | score on scale | | 9 weeks | | | | ID | Title | Description |
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| OG000 | Pregabalin | subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to pregabalin entered the double-blind phase with 35 days of dose achieved at the end of the single-blind treatment phase. | | OG001 | Placebo | subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to placebo received pregabalin 150 mg for 7 days and then placebo for 28 days. |
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| Secondary | Number of Subjects With >= 30% Reduction in Mean Pain Score During Single-blind Treatment | Responders = ≥30% reduction in mean pain score at end of single-blind treatment phase compared to weekly mean pain score at baseline. Mean of last 7 available pain scores from daily pain diary while on single-blind treatment. A Daily Pain Rating Score : 11-point numerical scale ranging from 0 ("no pain") to 10 ("worst possible pain"). | 256 subjects entered the single-blind treatment phase, one subject did not have enough DPRS assessments for calculation. | Posted | | Number | | participants | | Week 4 (end of single-blind treatment phase) | | | | ID | Title | Description |
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| OG000 | Pregabalin | subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day) for ≥4 days, then dose adjustment as needed. |
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| Secondary | Mean Pain Score for Responders at End of Single-blind Treatment Phase. Change From Baseline of Mean of Last 7 Available Pain Scores From Daily Pain Diary While on Single-blind Treatment. | Daily Pain Rating Score:11-point numerical scale 0 ("no pain") to 10 ("worst possible pain"). Responders = ≥30% reduction in mean pain score at end of single-blind treatment phase compared to weekly mean pain score at baseline. | number of subjects that can be analyzed for Change from Baseline at End of Single Blind. | Posted | | Mean | Standard Deviation | score on scale | | Week 4 | | | | ID | Title | Description |
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| OG000 | Pregabalin | subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day) for ≥4 days, then dose adjustment as needed. |
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| Secondary | Mean Pain Score for Non-responders at End of Single-blind Treatment Phase | Change from baseline of mean of last 7 available pain scores from daily pain diary while on single-blind treatment. Daily Pain Rating Score:11-point numerical scale 0 ("no pain") to 10 ("worst possible pain"). Non-Responders = <30% reduction in mean pain score at end of single-blind treatment phase compared to weekly mean pain score at baseline. | number of subjects that can be analyzed for Change from Baseline at End of Single Blind. | Posted | | Mean | Standard Deviation | score on scale | | Week 4 | | | | ID | Title | Description |
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| OG000 | Pregabalin | subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day) for ≥4 days, then dose adjustment as needed. |
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| Secondary | Categorized Daily Pain Score | Mean number of days in each pain category. DPRS Daily Pain Rating Score Categories: No pain (score 0), Mild pain (scores 1-3), Moderate pain (scores 4-6), Severe pain (scores 7-10) | Number of subjects analyzed for each pain category. | Posted | | Mean | Standard Deviation | days | | Week 9 | | | | ID | Title | Description |
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| OG000 | Pregabalin | subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to pregabalin entered the double-blind phase with 35 days of dose achieved at the end of the single-blind treatment phase. | | OG001 | Placebo | subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to placebo received pregabalin 150 mg for 7 days and then placebo for 28 days. |
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| Secondary | Time to Meaningful Increase in Pain During Double-blind Treatment Phase (Number of Participants) | Number of participants who experienced a meaningful increase in pain also includes participants who took rescue medication for pain due to peripheral neuropathic pain or discontinued from the study . | | Posted | | Number | | participants | | Week 9 | | | | ID | Title | Description |
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| OG000 | Pregabalin | subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to pregabalin entered the double-blind phase with 35 days of dose achieved at the end of the single-blind treatment phase. | | OG001 | Placebo | subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to placebo received pregabalin 150 mg for 7 days and then placebo for 28 days. |
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| Secondary | Mean Sleep Interference Score | Mean Sleep Interference (SI) score at end of Double-Blind treatment = mean of last 7 available SI scores from daily SI diary while on Double-Blind treatment. Daily SI rating scale (DSIS) consists of an 11-point numerical scale : Zero means "pain does not interfere with sleep" and 10 means "pain completely interferes with sleep." | | Posted | | Least Squares Mean | Standard Error | score on scale | | Week 9 | | | | ID | Title | Description |
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| OG000 | Pregabalin | subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to pregabalin entered the double-blind phase with 35 days of dose achieved at the end of the single-blind treatment phase. | | OG001 | Placebo | subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to placebo received pregabalin 150 mg for 7 days and then placebo for 28 days. |
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| Secondary | Weekly Mean Sleep Interference Scores During the Single-Blind Treatment Phase | Sleep Interference (SI) score at Week 0 and Week 4, end of single-bind treatment. Mean of last 7 available SI scores from daily SI diary while on single-blind treatment. Daily SI rating scale (DSIS) consists of an 11-point numerical scale : Zero means "pain does not interfere with sleep" and 10 means "pain completely interferes with sleep." | Last observation carried forward (LOCF) approach for patients who do not complete the study will be adopted. This is defined as the mean of the last 7 diary scores while on Double-Blind study drug, up to and including the day after the last day on drug (excluding the taper phase). | Posted | | Mean | Standard Deviation | score on scale | | 0 and 4 weeks | | | | ID | Title | Description |
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| OG000 | Pregabalin | subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day) for ≥4 days, then dose adjustment as needed. |
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| Secondary | Weekly Mean Sleep Interference Scores During the Double Blind Treatment Phase | Mean Sleep Interference scores for weeks 4, 5, 6, 7, 8 and 9. Mean of last 7 available SI scores from daily SI diary while on single-blind treatment. Daily SI rating scale (DSIS) consists of an 11-point numerical scale : Zero means "pain does not interfere with sleep" and 10 means "pain completely interferes with sleep." | | Posted | | Mean | Standard Deviation | score on scale | | Week 9 | | | | ID | Title | Description |
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| OG000 | Pregabalin | subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to pregabalin entered the double-blind phase with 35 days of dose achieved at the end of the single-blind treatment phase. | | OG001 | Placebo | subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to placebo received pregabalin 150 mg for 7 days and then placebo for 28 days. |
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| Secondary | Change in Sleep Interference Scores During Double Blind Treatment Phase | Change in Mean SI score: Mean SI score at observation minus mean SI score at week 4. Mean SI Score = mean of last 7 available SI scores from daily SI diary while on single-blind treatment. Daily SI rating scale (DSIS) is 11-point numerical scale : Zero means "pain does not interfere with sleep" and 10 means "pain completely interferes with sleep." | | Posted | | Least Squares Mean | Standard Error | score on scale | | 9 weeks | | | | ID | Title | Description |
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| OG000 | Pregabalin | subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to pregabalin entered the double-blind phase with 35 days of dose achieved at the end of the single-blind treatment phase. | | OG001 | Placebo | subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to placebo received pregabalin 150 mg for 7 days and then placebo for 28 days. |
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| Secondary | Intensity of Neuropathic Pain -Visual Analog Scale (NeP - VAS) | Change in Scale from randomization to Week 9. Scale to measure Neuropathic Pain -Visual Analog Scale (NeP - VAS): the subject places a mark on the VAS scale (0 to 100) where 0 represents the worst imaginable health state and 100 represents the best imaginable health state. | | Posted | | Least Squares Mean | Standard Error | scores on a scale | | Week 4, Week 9 | | | | ID | Title | Description |
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| OG000 | Pregabalin | subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to pregabalin entered the double-blind phase with 35 days of dose achieved at the end of the single-blind treatment phase. | | OG001 | Placebo | subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to placebo received pregabalin 150 mg for 7 days and then placebo for 28 days. |
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| Secondary | Change in Hospital Anxiety and Depression Scale Responses | Mean Change from Randomization in Score from Hospital Anxiety and Depression Scale (HADS): 2 subscales, measuring anxiety (HADS-A)and depression (HADS-D). 7 items in each subscale assessed on a scale of 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). which yields the score ranging 0-21. | | Posted | | Least Squares Mean | Standard Error | score on scale | | Week 9 | | | | ID | Title | Description |
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| OG000 | Pregabalin | subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to pregabalin entered the double-blind phase with 35 days of dose achieved at the end of the single-blind treatment phase. | | OG001 | Placebo | subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to placebo received pregabalin 150 mg for 7 days and then placebo for 28 days. |
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| Secondary | Change in Pain Treatment Satisfaction Scale (PTSS) | Mean Change: score from observation minus score from randomization: PTSS "Impact" module of 8-items & "Satisfaction" module of 6-items; item scores 1-5. Mean score for each module transformed onto scale 0- 100, where score 0 =worst possible response and score 100 =best possible response: Score =[(5 - mean non-missing items)*100]/4. | | Posted | | Least Squares Mean | Standard Error | score on scale | | Week 9 | | | | ID | Title | Description |
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| OG000 | Pregabalin | subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to pregabalin entered the double-blind phase with 35 days of dose achieved at the end of the single-blind treatment phase. | | OG001 | Placebo | subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to placebo received pregabalin 150 mg for 7 days and then placebo for 28 days. |
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| Secondary | Patient Global Impression of Change (PGIC) Categories by Number of Subjects | Number of subjects that responded to PGIC Categories. PGIC is a subject-rated instrument that measures change in the subject's overall status on a 7-point scale. Scores range from 1 (very much improved) to 7 (very much worse). | | Posted | | Number | | participants | | Week 9 | | | | ID | Title | Description |
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| OG000 | Pregabalin | subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to pregabalin entered the double-blind phase with 35 days of dose achieved at the end of the single-blind treatment phase. | | OG001 | Placebo | subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to placebo received pregabalin 150 mg for 7 days and then placebo for 28 days. |
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| Secondary | Change in Modified Brief Pain Inventory (mBPI) for Pain Interference or Pain Severity. | Mean Change from Randomization: score at mBPI observation minus score at randomization. mBPI is extent to which pain interferes with daily activities on a 0 (no interference) to 10 (completely interfered) scale. | | Posted | | Least Squares Mean | Standard Error | score on scale | | Week 9 | | | | ID | Title | Description |
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| OG000 | Pregabalin | subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to pregabalin entered the double-blind phase with 35 days of dose achieved at the end of the single-blind treatment phase. | | OG001 | Placebo | subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to placebo received pregabalin 150 mg for 7 days and then placebo for 28 days. |
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| Secondary | Change in Euro Quality of Life (EQ-5D) Health State Profile and Visual Analog Scale Components | two components to the EQ-5D: a Health State Profile (scores from five domains are used to calculate the utility score :0 refers to dead and a score of 1 refers to perfect health) and a Visual Analogue Scale (VAS) (0 represents the worst imaginable health state and 100 represents the best imaginable health state) | | Posted | | Least Squares Mean | Standard Error | score on scale | | Week 9 | | | | ID | Title | Description |
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| OG000 | Pregabalin | subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to pregabalin entered the double-blind phase with 35 days of dose achieved at the end of the single-blind treatment phase. | | OG001 | Placebo | subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to placebo received pregabalin 150 mg for 7 days and then placebo for 28 days. |
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