Safety and Efficacy of Dextromethorphan and Quinidine in the Treatment of the Pain of Diabetic Neuropathy

• Status: Completed
• Trial end date: 2007-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether dextromethorphan (Neurodex) and quinidine are effective in the treatment of pain of diabetic neuropathy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Avanir Pharmaceuticals
• Treatments: Dextromethorphan; Quinidine; Quinidine gluconate

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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