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

Last updated: July 13, 2016
Sponsor: Avanir Pharmaceuticals
Overall Status: Completed

Phase

3

Condition

Chronic Pain

Pain

Diabetic Neuropathy

Treatment

N/A

Clinical Study ID

NCT00113620
04-AVR-109
  • Ages 18-80
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of diabetes mellitus

  • Established diabetic therapy for at least 3 months

  • Lab-supported diagnosis of painful diabetic distal symmetric sensory/motorpolyneuropathy

  • Pain the previous three months

  • Not pregnant

Exclusion

Exclusion Criteria:

  • Patient failed adequate trial of 3 or more medications or has required narcotics forpain

  • 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 anothertrial

  • Patient has previously received treatment with dextromethorphan and quinidine

Study Design

Total Participants: 450
Study Start date:
July 01, 2005
Estimated Completion Date:
February 28, 2007

Connect with a study center

  • Pivotal Research Centers

    Mesa, Arizona 85210
    United States

    Site Not Available

  • Dedicate Clinical Research, Inc.

    Sun City, Arizona 85351
    United States

    Site Not Available

  • Central Arkansas Research

    Hot Springs, Arkansas 71913
    United States

    Site Not Available

  • Research Solutions

    Jonesboro, Arkansas 72401
    United States

    Site Not Available

  • Bay Area Foot Care

    Castro Valley, California 94546
    United States

    Site Not Available

  • South Bay Clinical Research Inc.

    Inglewood, California 90301
    United States

    Site Not Available

  • Pacific Sleep Medicine Services, Inc.

    Los Angeles, California 90048
    United States

    Site Not Available

  • Pacific Sleep Medicine Services, Inc.

    Palm Springs, California 92262
    United States

    Site Not Available

  • Northern California Research Group

    Sacramento, California 95831
    United States

    Site Not Available

  • Diablo Clinical Research, Inc.

    Walnut Creek, California 94598
    United States

    Site Not Available

  • Tampa Bay Medical Research

    Clearwater, Florida 33761
    United States

    Site Not Available

  • University Clinical Research - DeLand

    DeLand, Florida 32720
    United States

    Site Not Available

  • The Center for Diabetes and Endocrine Care

    Hollywood, Florida 33021
    United States

    Site Not Available

  • FPA Clinical Research

    Kissimmee, Florida 34741
    United States

    Site Not Available

  • Suncoast Neuroscience Associates, Inc.

    St. Petersburg, Florida 33701
    United States

    Site Not Available

  • Neurology Clinical Research, Inc.

    Sunrise, Florida 33351
    United States

    Site Not Available

  • Laszlo J. Mate, MD

    West Palm Beach, Florida 33407
    United States

    Site Not Available

  • East-West Medical Research Institute

    Honolulu, Hawaii 96814
    United States

    Site Not Available

  • Medisphere Medical Research Center, LLC

    Evansville, Indiana 47714
    United States

    Site Not Available

  • Investigative Clinical Reserach of Indiana, LLC

    Indianapolis, Indiana 46254
    United States

    Site Not Available

  • Crossroads Research, Inc.

    Owings Mills, Maryland 21117
    United States

    Site Not Available

  • Medex Healthcare Research, Inc.

    St. Louis, Missouri 63117
    United States

    Site Not Available

  • Radiant Research - St. Louis

    St. Louis, Missouri 63141
    United States

    Site Not Available

  • Montana Neuroscience Institute

    Missoula, Montana 59802
    United States

    Site Not Available

  • Creighton Diabetes Center

    Omaha, Nebraska 68131
    United States

    Site Not Available

  • Advanced Biomedical Research of America

    Las Vegas, Nevada 89123
    United States

    Site Not Available

  • Lovelace Scientific Resources

    Albuquerque, New Mexico 87108
    United States

    Site Not Available

  • Upstate Clinical Research, LLC

    Albany, New York 12205
    United States

    Site Not Available

  • DiGiovanna Family Care Center

    Great Neck, New York 11021
    United States

    Site Not Available

  • Weill Medical College of Cornell University - Peripheral Neuropathy Center

    New York, New York 10022
    United States

    Site Not Available

  • Vital Research

    Greensboro, North Carolina 27408
    United States

    Site Not Available

  • Radiant Research

    Cincinnati, Ohio 45236
    United States

    Site Not Available

  • Radiant Research - Akron

    Mogadore, Ohio 44260
    United States

    Site Not Available

  • Neurology & Neuroscience Center of Ohio

    Toledo, Ohio 43623
    United States

    Site Not Available

  • Knights Road Medical

    Bensalem, Pennsylvania 19020
    United States

    Site Not Available

  • Omega Medical Research

    Warwick, Rhode Island 02886
    United States

    Site Not Available

  • Radiant Research - Greer

    Greer, South Carolina 29651
    United States

    Site Not Available

  • Radiant Research

    Dallas, Texas 75231
    United States

    Site Not Available

  • Nerve & Muscle Center of Texas

    Houston, Texas 77030
    United States

    Site Not Available

  • Diabetes & Glandular Disease Research Assoc.

    San Antonio, Texas 78229
    United States

    Site Not Available

  • SAM Clinical Research

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Hampton Roads Center for Clinical Research

    Norfolk, Virginia 23502
    United States

    Site Not Available

  • Tidewater Integrated Medical Research

    Virginia Beach, Virginia 23451
    United States

    Site Not Available

  • University of Wisconsin Medical School

    Madison, Wisconsin 53792
    United States

    Site Not Available

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