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

Pain Clinical Trial

Official title:

A Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Safety and Efficacy of Dextromethorphan and Quinidine at Two Dose Levels in the Treatment of the Pain of Diabetic Neuropathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00113620
• Other study ID #: 04-AVR-109
• Status: Completed
• Phase: Phase 3
• First received: June 9, 2005
• Last updated: July 13, 2016
• Start date: July 2005
• Est. completion date: February 2007

Study information

• Verified date: July 2016
• Source: Avanir Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: February 2007
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Neuropathy
• Pain

Intervention

Drug:
• Neurodex

Locations

Country	Name	City	State
United States	Upstate Clinical Research, LLC	Albany	New York
United States	Lovelace Scientific Resources	Albuquerque	New Mexico
United States	Knights Road Medical	Bensalem	Pennsylvania
United States	Bay Area Foot Care	Castro Valley	California
United States	Radiant Research	Cincinnati	Ohio
United States	Tampa Bay Medical Research	Clearwater	Florida
United States	Radiant Research	Dallas	Texas
United States	University Clinical Research - DeLand	DeLand	Florida
United States	Medisphere Medical Research Center, LLC	Evansville	Indiana
United States	DiGiovanna Family Care Center	Great Neck	New York
United States	Vital Research	Greensboro	North Carolina
United States	Radiant Research - Greer	Greer	South Carolina
United States	The Center for Diabetes and Endocrine Care	Hollywood	Florida
United States	East-West Medical Research Institute	Honolulu	Hawaii
United States	Central Arkansas Research	Hot Springs	Arkansas
United States	Nerve & Muscle Center of Texas	Houston	Texas
United States	Investigative Clinical Reserach of Indiana, LLC	Indianapolis	Indiana
United States	South Bay Clinical Research Inc.	Inglewood	California
United States	Research Solutions	Jonesboro	Arkansas
United States	FPA Clinical Research	Kissimmee	Florida
United States	Advanced Biomedical Research of America	Las Vegas	Nevada
United States	Pacific Sleep Medicine Services, Inc.	Los Angeles	California
United States	University of Wisconsin Medical School	Madison	Wisconsin
United States	Pivotal Research Centers	Mesa	Arizona
United States	Montana Neuroscience Institute	Missoula	Montana
United States	Radiant Research - Akron	Mogadore	Ohio
United States	Weill Medical College of Cornell University - Peripheral Neuropathy Center	New York	New York
United States	Hampton Roads Center for Clinical Research	Norfolk	Virginia
United States	Creighton Diabetes Center	Omaha	Nebraska
United States	Crossroads Research, Inc.	Owings Mills	Maryland
United States	Pacific Sleep Medicine Services, Inc.	Palm Springs	California
United States	Northern California Research Group	Sacramento	California
United States	Diabetes & Glandular Disease Research Assoc.	San Antonio	Texas
United States	SAM Clinical Research	San Antonio	Texas
United States	Medex Healthcare Research, Inc.	St. Louis	Missouri
United States	Radiant Research - St. Louis	St. Louis	Missouri
United States	Suncoast Neuroscience Associates, Inc.	St. Petersburg	Florida
United States	Dedicate Clinical Research, Inc.	Sun City	Arizona
United States	Neurology Clinical Research, Inc.	Sunrise	Florida
United States	Neurology & Neuroscience Center of Ohio	Toledo	Ohio
United States	Tidewater Integrated Medical Research	Virginia Beach	Virginia
United States	Diablo Clinical Research, Inc.	Walnut Creek	California
United States	Omega Medical Research	Warwick	Rhode Island
United States	Laszlo J. Mate, MD	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Avanir Pharmaceuticals

Country where clinical trial is conducted

United States, 

References & Publications (1)

Shaibani AI, Pope LE, Thisted R, Hepner A. Efficacy and safety of dextromethorphan/quinidine at two dosage levels for diabetic neuropathic pain: a double-blind, placebo-controlled, multicenter study. Pain Med. 2012 Feb;13(2):243-54. doi: 10.1111/j.1526-46 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain rating scale obtained from patient diaries
Secondary	Additional diary rating scales and scores obtained from clinic visits