Painful Diabetic Neuropathy Clinical Trial
Official title:
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
| NCT number | NCT01056315 |
| Other study ID # | 131885 |
| Secondary ID | |
| Status | Terminated |
| Phase | Phase 2 |
| First received | |
| Last updated | |
| Start date | November 2009 |
| Est. completion date | January 2011 |
| Verified date | October 2019 |
| Source | Grünenthal GmbH |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This trial is assessing the analgesic efficacy and safety of a new central analgesic in subjects with pain due to diabetic peripheral neuropathy (DPN).
| Status | Terminated |
| Enrollment | 553 |
| Est. completion date | January 2011 |
| Est. primary completion date | January 2011 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Site 225 | Asheville | North Carolina |
| United States | Site 142 | Atlanta | Georgia |
| United States | Site 105 | Austin | Texas |
| United States | Site 211 | Baltimore | Maryland |
| United States | Site 227 | Canton | Ohio |
| United States | Site 128 | Chicago | Illinois |
| United States | Site 223 | Chicago | Illinois |
| United States | Site 233 | Cincinnati | Ohio |
| United States | Site 213 | Corpus Christi | Texas |
| United States | Site 136 | Deerfield Beach | Florida |
| United States | Site 137 | Deerfield Beach | Florida |
| United States | Site 140 | Deerfield Beach | Florida |
| United States | Site 216 | Deerfield Beach | Florida |
| United States | Site 217 | Deerfield Beach | Florida |
| United States | Site 218 | Deerfield Beach | Florida |
| United States | Site 108 | East Bridgewater | Massachusetts |
| United States | Site 129 | Escondido | California |
| United States | Site 127 | Fairhope | Alabama |
| United States | Site 117 | Fort Myers | Florida |
| United States | Site 209 | Fullerton | California |
| United States | Site 115 | High Point | North Carolina |
| United States | Site 130 | Homewood | Alabama |
| United States | Site 110 | Houston | Texas |
| United States | Site 123 | Houston | Texas |
| United States | Site 204 | Houston | Texas |
| United States | Site 210 | Houston | Texas |
| United States | Site 231 | Houston | Texas |
| United States | Site 124 | Jacksonville | Florida |
| United States | Site 228 | Jupiter | Florida |
| United States | Site 113 | Las Vegas | Nevada |
| United States | Site 114 | Leawood | Kansas |
| United States | Site 135 | Long Beach | California |
| United States | Site 230 | New York | New York |
| United States | Site 202 | Northridge | California |
| United States | Site 208 | Northridge | California |
| United States | Site 219 | Northridge | California |
| United States | Site 101 | Orlando | Florida |
| United States | Site 226 | Orlando | Florida |
| United States | Site 102 | Paducah | Kentucky |
| United States | Site 104 | Philadelphia | Pennsylvania |
| United States | Site 106 | Philadelphia | Pennsylvania |
| United States | Site 205 | Philadelphia | Pennsylvania |
| United States | Site 122 | Princeton | New Jersey |
| United States | Site 139 | Provo | Utah |
| United States | Site 109 | Rochester | New York |
| United States | Site 131 | San Antonio | Texas |
| United States | Site 215 | San Antonio | Texas |
| United States | Site 221 | San Antonio | Texas |
| United States | Site 203 | San Francisco | California |
| United States | Site 116 | Santa Ana | California |
| United States | Site 118 | Santa Ana | California |
| United States | Site 121 | Santa Ana | California |
| United States | Site 133 | Santa Ana | California |
| United States | Site 206 | Sarasota | Florida |
| United States | Site 111 | Toledo | Ohio |
| United States | Site 125 | Toledo | Ohio |
| United States | Site 112 | Tucson | Arizona |
| United States | Site 126 | Vista | California |
| United States | Site 214 | Vista | California |
| United States | Site 201 | Waterbury | Connecticut |
| United States | Site 212 | West Palm Beach | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Grünenthal GmbH |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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). | Baseline; last 7 days of 12-week maintenance | |
| Secondary | 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 | ||
| Secondary | 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 | ||
| Secondary | 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 | ||
| Secondary | Change From Baseline of the Weekly Mean of Night Pain Intensity (on an 11-point NRS). | Baseline; weekly mean | ||
| Secondary | 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 | ||
| Secondary | 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 | ||
| Secondary | 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 | ||
| Secondary | 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. | ||
| Secondary | 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. | ||
| Secondary | 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. | ||
| Secondary | 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. | ||
| Secondary | 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. | ||
| Secondary | Time to Treatment Discontinuation Due to Lack of Efficacy. | Baseline to time to treatment discontinuation | ||
| Secondary | Assessment of Rescue Medication Usage During the 4-week Titration. | 4-week titration phase |
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