Status:
COMPLETED
Safety and Efficacy of Dextromethorphan and Quinidine in the Treatment of the Pain of Diabetic Neuropathy
Lead Sponsor:
Avanir Pharmaceuticals
Conditions:
Pain
Diabetic Neuropathy
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine whether dextromethorphan (Neurodex) and quinidine are effective in the treatment of pain of diabetic neuropathy.
Eligibility Criteria
Inclusion
- Diagnosis of diabetes mellitus
- Established diabetic therapy for at least 3 months
- Lab-supported diagnosis of painful diabetic distal symmetric sensory/motor polyneuropathy
- Pain the previous three months
- Not pregnant
Exclusion
- Patient failed adequate trial of 3 or more medications or has required narcotics for pain
- History of torsades de pointes
- Sensitivity to quinidine or opiate drugs (codeine, etc)
- Severe pain that could confound the assessment
- Patient has had any amputations
- Patient has participated in the past 30 days or is currently participating in another trial
- Patient has previously received treatment with dextromethorphan and quinidine
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2007
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT00113620
Start Date
July 1 2005
End Date
February 1 2007
Last Update
July 14 2016
Active Locations (44)
Enter a location and click search to find clinical trials sorted by distance.
1
Pivotal Research Centers
Mesa, Arizona, United States, 85210
2
Dedicate Clinical Research, Inc.
Sun City, Arizona, United States, 85351
3
Central Arkansas Research
Hot Springs, Arkansas, United States, 71913
4
Research Solutions
Jonesboro, Arkansas, United States, 72401