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Clinical Trial Details — Status: Terminated

Administrative data

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

Study information

Verified date October 2019
Source Grünenthal GmbH
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
GRT3938Y
Overencapsulated tablets of GRT3983Y, 100 to 300mg daily dose, 16 weeks treatment.
Placebo
Overencapsulated tablets of placebo, 16 weeks treatment.

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Grünenthal GmbH

Country where clinical trial is conducted

United States, 

Outcome

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
See also
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Completed NCT03769675 - Quantitative Assessment of Painful Diabetic Peripheral Neuropathy After High Frequency Spinal Cord Stimulation N/A
Completed NCT03755934 - Efficacy and Safety of MEDI7352 in Subjects With Painful Diabetic Neuropathy Phase 2
Not yet recruiting NCT05118217 - Microvascular Dysfunction in Diabetic Peripheral Neuropathy