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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00113620
Recruitment Status : Completed
First Posted : June 10, 2005
Last Update Posted : July 14, 2016
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Pain Diabetic Neuropathy Drug: Neurodex Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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
Study Start Date : July 2005
Actual Primary Completion Date : February 2007
Actual Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Pain rating scale obtained from patient diaries

Secondary Outcome Measures :
  1. Additional diary rating scales and scores obtained from clinic visits

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00113620

  Hide Study Locations
United States, Arizona
Pivotal Research Centers
Mesa, Arizona, United States, 85210
Dedicate Clinical Research, Inc.
Sun City, Arizona, United States, 85351
United States, Arkansas
Central Arkansas Research
Hot Springs, Arkansas, United States, 71913
Research Solutions
Jonesboro, Arkansas, United States, 72401
United States, California
Bay Area Foot Care
Castro Valley, California, United States, 94546
South Bay Clinical Research Inc.
Inglewood, California, United States, 90301
Pacific Sleep Medicine Services, Inc.
Los Angeles, California, United States, 90048
Pacific Sleep Medicine Services, Inc.
Palm Springs, California, United States, 92262
Northern California Research Group
Sacramento, California, United States, 95831
Diablo Clinical Research, Inc.
Walnut Creek, California, United States, 94598
United States, Florida
Tampa Bay Medical Research
Clearwater, Florida, United States, 33761
University Clinical Research - DeLand
DeLand, Florida, United States, 32720
The Center for Diabetes and Endocrine Care
Hollywood, Florida, United States, 33021
FPA Clinical Research
Kissimmee, Florida, United States, 34741
Suncoast Neuroscience Associates, Inc.
St. Petersburg, Florida, United States, 33701
Neurology Clinical Research, Inc.
Sunrise, Florida, United States, 33351
Laszlo J. Mate, MD
West Palm Beach, Florida, United States, 33407
United States, Hawaii
East-West Medical Research Institute
Honolulu, Hawaii, United States, 96814
United States, Indiana
Medisphere Medical Research Center, LLC
Evansville, Indiana, United States, 47714
Investigative Clinical Reserach of Indiana, LLC
Indianapolis, Indiana, United States, 46254
United States, Maryland
Crossroads Research, Inc.
Owings Mills, Maryland, United States, 21117
United States, Missouri
Medex Healthcare Research, Inc.
St. Louis, Missouri, United States, 63117
Radiant Research - St. Louis
St. Louis, Missouri, United States, 63141
United States, Montana
Montana Neuroscience Institute
Missoula, Montana, United States, 59802
United States, Nebraska
Creighton Diabetes Center
Omaha, Nebraska, United States, 68131
United States, Nevada
Advanced Biomedical Research of America
Las Vegas, Nevada, United States, 89123
United States, New Mexico
Lovelace Scientific Resources
Albuquerque, New Mexico, United States, 87108
United States, New York
Upstate Clinical Research, LLC
Albany, New York, United States, 12205
DiGiovanna Family Care Center
Great Neck, New York, United States, 11021
Weill Medical College of Cornell University - Peripheral Neuropathy Center
New York, New York, United States, 10022
United States, North Carolina
Vital Research
Greensboro, North Carolina, United States, 27408
United States, Ohio
Radiant Research
Cincinnati, Ohio, United States, 45236
Radiant Research - Akron
Mogadore, Ohio, United States, 44260
Neurology & Neuroscience Center of Ohio
Toledo, Ohio, United States, 43623
United States, Pennsylvania
Knights Road Medical
Bensalem, Pennsylvania, United States, 19020
United States, Rhode Island
Omega Medical Research
Warwick, Rhode Island, United States, 02886
United States, South Carolina
Radiant Research - Greer
Greer, South Carolina, United States, 29651
United States, Texas
Radiant Research
Dallas, Texas, United States, 75231
Nerve & Muscle Center of Texas
Houston, Texas, United States, 77030
Diabetes & Glandular Disease Research Assoc.
San Antonio, Texas, United States, 78229
SAM Clinical Research
San Antonio, Texas, United States, 78229
United States, Virginia
Hampton Roads Center for Clinical Research
Norfolk, Virginia, United States, 23502
Tidewater Integrated Medical Research
Virginia Beach, Virginia, United States, 23451
United States, Wisconsin
University of Wisconsin Medical School
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
Avanir Pharmaceuticals

Publications of Results: Identifier: NCT00113620     History of Changes
Other Study ID Numbers: 04-AVR-109
First Posted: June 10, 2005    Key Record Dates
Last Update Posted: July 14, 2016
Last Verified: July 2016

Keywords provided by Avanir Pharmaceuticals:
distal symmetrical
lower extremities

Additional relevant MeSH terms:
Diabetic Neuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Quinidine gluconate
Antitussive Agents
Respiratory System Agents
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Anti-Arrhythmia Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Voltage-Gated Sodium Channel Blockers