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

Phase 3

Completed

• Conditions: Pain; Diabetic Neuropathy

• Registration Number: NCT00113620
• Lead Sponsor: Avanir Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-06-09
• Study First Submitted QC: 2005-06-09
• Study First Posted: 2005-06-10
• Study Start: 2005-07
• Primary Completion: 2007-02
• Study Completion: 2007-02
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-13
• Last Update Posted: 2016-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 450

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain rating scale obtained from patient diaries

Secondary Outcome Measures

Name	Time	Method
Additional diary rating scales and scores obtained from clinic visits

Trial Locations

Locations (42)

Pivotal Research Centers; 🇺🇸 Mesa, Arizona, United States

Dedicate Clinical Research, Inc.; 🇺🇸 Sun City, Arizona, United States

Central Arkansas Research; 🇺🇸 Hot Springs, Arkansas, United States

Research Solutions; 🇺🇸 Jonesboro, Arkansas, United States

Bay Area Foot Care; 🇺🇸 Castro Valley, California, United States

South Bay Clinical Research Inc.; 🇺🇸 Inglewood, California, United States

Pacific Sleep Medicine Services, Inc.; 🇺🇸 Palm Springs, California, United States

Northern California Research Group; 🇺🇸 Sacramento, California, United States

Diablo Clinical Research, Inc.; 🇺🇸 Walnut Creek, California, United States

Tampa Bay Medical Research; 🇺🇸 Clearwater, Florida, United States

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