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

July 13, 2016 updated by: Avanir Pharmaceuticals

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

450

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Pain rating scale obtained from patient diaries

Secondary Outcome Measures

Outcome Measure
Additional diary rating scales and scores obtained from clinic visits

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Avanir Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Primary Completion (Actual)

February 1, 2007

Study Completion (Actual)

February 1, 2007

Study Registration Dates

First Submitted

June 9, 2005

First Submitted That Met QC Criteria

June 9, 2005

First Posted (Estimate)

June 10, 2005

Study Record Updates

Last Update Posted (Estimate)

July 14, 2016

Last Update Submitted That Met QC Criteria

July 13, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04-AVR-109

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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