A Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel-group Trial to Assess the Analgesic Efficacy and Safety of a New Analgesic Compared to Placebo in Subjects With Painful Diabetic Peripheral Neuropathy

简要总结

主要结局

次要结局

• Change From Baseline in the Mean of the Daily Average Pain Intensity Scores (on an 11-point NRS) Over the Entire 12-week Maintenance(Baseline, Daily scores over entire 12 week maintenance)
• Change From Baseline of the Weekly Mean of Current Pain Intensity (on an 11-point NRS) in the Evening and in the Morning, Respectively.(Baseline, weekly mean)
• Patient Global Impression of Change Using a 7-point Verbal Rating Scale, on Day 29, Day 71 and Day 113 (Final Visit).(Day 29, Day 71 and Day 113.)
• Proportion of Subjects Achieving Various Levels of Pain Improvement (Including 30% and 50%) Based on the Percent Change From Baseline to the Last 7 Days of the 12-week Maintenance on an 11-point NRS (Responder Analysis).(Baseline, Last 7 days of 12-week maintenance)
• Change From Baseline in the Mean of the Daily Average Pain Intensity Scores (on an 11-point NRS) Over Each Week of Maintenance.(Baseline; daily scores over each week of maintenance)
• Change From Baseline of the Weekly Mean of Night Pain Intensity (on an 11-point NRS).(Baseline; weekly mean)
• Brief Pain Inventory Scores: Changes From Baseline to Day 8, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, Day 85, Day 99, and Day 113 (Final Visit).(Baseline, weekly mean)
• Neuropathic Pain Symptoms Inventory: Changes From Baseline to Day 8, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, Day 85, Day 99 and Day 113 (Final Visit)(Baseline, weekly mean)
• EuroQol-5 Dimension Health Questionnaire: Changes From Baseline to Day 29, Day 71 and Day 113 (Final Visit).(Baseline, Day 29, Day 71 and Day 113.)
• Short Form 36 Health Survey (SF-36®): Changes From Baseline to Day 29, Day 71 and Day 113 (Final Visit).(Baseline, Day 29, Day 71 and Day 113.)
• Hospital Anxiety and Depression Scale: Changes From Baseline to Day 29, Day 71 and Day 113 (Final Visit).(Baseline, Day 29, Day 71 and Day 113.)
• Assessment of Each Item of the Leeds Sleep Evaluation Questionnaire: Changes From Baseline to Day 29, Day 71 and Day 113 (Final Visit).(Baseline, Day 29, Day 71 and Day 113.)
• Time to Treatment Discontinuation Due to Lack of Efficacy.(Baseline to time to treatment discontinuation)
• Assessment of Rescue Medication Usage During the 4-week Titration.(4-week titration phase)