This trial is assessing the analgesic efficacy and safety of a new central analgesic in subjects with pain due to diabetic peripheral neuropathy (DPN).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
553
Average Pain Intensity
The primary efficacy endpoint is the change from baseline in the mean of the daily average pain intensity scores (on an 11-point NRS) over the last 7 days of the 12-week maintenance (Week 16).
Time frame: 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 the Entire 12-week Maintenance
Time frame: Baseline, Daily scores over entire 12 week maintenance
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).
Time frame: 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.
Time frame: Baseline; daily scores over each week of maintenance
Change From Baseline of the Weekly Mean of Night Pain Intensity (on an 11-point NRS).
Time frame: Baseline; weekly mean
Change From Baseline of the Weekly Mean of Current Pain Intensity (on an 11-point NRS) in the Evening and in the Morning, Respectively.
Time frame: 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).
Time frame: 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)
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Site 127
Fairhope, Alabama, United States
Site 130
Homewood, Alabama, United States
Site 112
Tucson, Arizona, United States
Site 129
Escondido, California, United States
Site 209
Fullerton, California, United States
Site 135
Long Beach, California, United States
Site 202
Northridge, California, United States
Site 208
Northridge, California, United States
Site 219
Northridge, California, United States
Site 203
San Francisco, California, United States
...and 51 more locations
Time frame: 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).
Time frame: 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).
Time frame: Baseline, Day 29, Day 71 and Day 113.
EuroQol-5 Dimension Health Questionnaire: Changes From Baseline to Day 29, Day 71 and Day 113 (Final Visit).
Time frame: 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).
Time frame: 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).
Time frame: Baseline, Day 29, Day 71 and Day 113.
Time to Treatment Discontinuation Due to Lack of Efficacy.
Time frame: Baseline to time to treatment discontinuation
Assessment of Rescue Medication Usage During the 4-week Titration.
Time frame: 4-week titration phase