A Trial in Painful Diabetic Peripheral Neuropathy With GRT3983Y

Phase 2

Terminated

Conditions: Painful Diabetic Neuropathy

Interventions: Drug: GRT3938Y
Drug: Placebo

Registration Number: NCT01056315

Lead Sponsor: Grünenthal GmbH

Brief Summary: This trial is assessing the analgesic efficacy and safety of a new central analgesic in subjects with pain due to diabetic peripheral neuropathy (DPN).

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 553

Inclusion Criteria

Symmetrical painful diabetic peripheral neuropathy

Exclusion Criteria

History of hypersensitivity, allergy or contraindication to opioids and acetaminophen
Confounding painful conditions
Significant vascular disease
History or risk of seizure
Chronic disease that might effect drug absorption, distribution, metabolism, or excretion
Female subjects who are being pregnant or breastfeeding
Evidence or history of alcohol, medication, or drug abuse

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A GRT3983Y	GRT3938Y	Participants randomly assigned to receive GRT3983Y.
B Placebo	Placebo	Participants randomly assigned to placebo.

Primary Outcome Measures

Name	Time	Method
Average Pain Intensity	Baseline; last 7 days of 12-week maintenance	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).

Secondary Outcome Measures

Name	Time	Method
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.
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.
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

Trial Locations

Locations (61): Site 209
🇺🇸
Fullerton, California, United States
Site 136
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Deerfield Beach, Florida, United States
Site 137
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Deerfield Beach, Florida, United States
Site 128
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Chicago, Illinois, United States
Site 218
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Deerfield Beach, Florida, United States
Site 206
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Sarasota, Florida, United States
Site 117
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Fort Myers, Florida, United States
Site 223
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Chicago, Illinois, United States
Site 211
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Baltimore, Maryland, United States
Site 225
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Asheville, North Carolina, United States
Site 127
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Fairhope, Alabama, United States
Site 112
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Tucson, Arizona, United States
Site 129
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Escondido, California, United States
Site 202
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Northridge, California, United States
Site 208
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Northridge, California, United States
Site 219
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Northridge, California, United States
Site 116
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Santa Ana, California, United States
Site 118
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Santa Ana, California, United States
Site 121
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Santa Ana, California, United States
Site 133
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Santa Ana, California, United States
Site 126
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Vista, California, United States
Site 214
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Vista, California, United States
Site 201
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Waterbury, Connecticut, United States
Site 140
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Deerfield Beach, Florida, United States
Site 216
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Deerfield Beach, Florida, United States
Site 228
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Jupiter, Florida, United States
Site 212
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West Palm Beach, Florida, United States
Site 142
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Atlanta, Georgia, United States
Site 114
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Leawood, Kansas, United States
Site 113
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Las Vegas, Nevada, United States
Site 102
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Paducah, Kentucky, United States
Site 122
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Princeton, New Jersey, United States
Site 109
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Rochester, New York, United States
Site 230
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New York, New York, United States
Site 115
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High Point, North Carolina, United States
Site 227
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Canton, Ohio, United States
Site 111
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Toledo, Ohio, United States
Site 125
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Toledo, Ohio, United States
Site 104
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Philadelphia, Pennsylvania, United States
Site 106
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Philadelphia, Pennsylvania, United States
Site 213
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Corpus Christi, Texas, United States
Site 205
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Philadelphia, Pennsylvania, United States
Site 105
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Austin, Texas, United States
Site 123
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Houston, Texas, United States
Site 204
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Houston, Texas, United States
Site 110
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Houston, Texas, United States
Site 231
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Houston, Texas, United States
Site 210
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Houston, Texas, United States
Site 203
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San Francisco, California, United States
Site 233
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Cincinnati, Ohio, United States
Site 131
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San Antonio, Texas, United States
Site 221
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San Antonio, Texas, United States
Site 130
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Homewood, Alabama, United States
Site 135
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Long Beach, California, United States
Site 215
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San Antonio, Texas, United States
Site 226
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Orlando, Florida, United States
Site 124
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Jacksonville, Florida, United States
Site 139
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Provo, Utah, United States
Site 108
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East Bridgewater, Massachusetts, United States
Site 217
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Deerfield Beach, Florida, United States
Site 101
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Orlando, Florida, United States