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

The Center for Diabetes and Endocrine Care; 🇺🇸 Hollywood, Florida, United States

FPA Clinical Research; 🇺🇸 Kissimmee, Florida, United States

Laszlo J. Mate, MD; 🇺🇸 West Palm Beach, Florida, United States

Montana Neuroscience Institute; 🇺🇸 Missoula, Montana, United States

Tidewater Integrated Medical Research; 🇺🇸 Virginia Beach, Virginia, United States

Upstate Clinical Research, LLC; 🇺🇸 Albany, New York, United States

Investigative Clinical Reserach of Indiana, LLC; 🇺🇸 Indianapolis, Indiana, United States

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

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

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

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

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

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

Neurology Clinical Research, Inc.; 🇺🇸 Sunrise, Florida, United States

Medisphere Medical Research Center, LLC; 🇺🇸 Evansville, Indiana, United States

Medex Healthcare Research, Inc.; 🇺🇸 St. Louis, Missouri, United States

Radiant Research - St. Louis; 🇺🇸 St. Louis, Missouri, United States

Lovelace Scientific Resources; 🇺🇸 Albuquerque, New Mexico, United States

DiGiovanna Family Care Center; 🇺🇸 Great Neck, New York, United States

Weill Medical College of Cornell University - Peripheral Neuropathy Center; 🇺🇸 New York, New York, United States

Vital Research; 🇺🇸 Greensboro, North Carolina, United States

Radiant Research - Akron; 🇺🇸 Mogadore, Ohio, United States

Neurology & Neuroscience Center of Ohio; 🇺🇸 Toledo, Ohio, United States

Knights Road Medical; 🇺🇸 Bensalem, Pennsylvania, United States

Omega Medical Research; 🇺🇸 Warwick, Rhode Island, United States

Nerve & Muscle Center of Texas; 🇺🇸 Houston, Texas, United States

Radiant Research - Greer; 🇺🇸 Greer, South Carolina, United States

Hampton Roads Center for Clinical Research; 🇺🇸 Norfolk, Virginia, United States

East-West Medical Research Institute; 🇺🇸 Honolulu, Hawaii, United States

Research Solutions; 🇺🇸 Jonesboro, Arkansas, United States

Advanced Biomedical Research of America; 🇺🇸 Las Vegas, Nevada, United States

Diabetes & Glandular Disease Research Assoc.; 🇺🇸 San Antonio, Texas, United States

SAM Clinical Research; 🇺🇸 San Antonio, Texas, United States

Creighton Diabetes Center; 🇺🇸 Omaha, Nebraska, United States

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

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

University Clinical Research - DeLand; 🇺🇸 DeLand, Florida, United States

Suncoast Neuroscience Associates, Inc.; 🇺🇸 St. Petersburg, Florida, United States

University of Wisconsin Medical School; 🇺🇸 Madison, Wisconsin, United States

Crossroads Research, Inc.; 🇺🇸 Owings Mills, Maryland, United States

Radiant Research; 🇺🇸 Dallas, Texas, United States