Safety and Efficacy of Dextromethorphan and Quinidine in the Treatment of the Pain of Diabetic Neuropathy
NCT ID: NCT00113620
Last Updated: 2016-07-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
450 participants
INTERVENTIONAL
2005-07-31
2007-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of Clonidine Hydrochloride Topical Gel, 0.1% in the Treatment of Pain Associated With Diabetic Neuropathy
NCT02068027
Dextromethorphan Versus Placebo for Neuropathic Pain
NCT00001344
Omnitram Safety and Efficacy in the Treatment of Diabetic Neuropathy
NCT03664921
Low-Dose Naltrexone for the Treatment of Painful Diabetic Neuropathy
NCT04678895
Lidocaine for Diabetic Peripheral Neuropathy
NCT02363803
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Neurodex
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Avanir Pharmaceuticals
INDUSTRY
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Pivotal Research Centers
Mesa, Arizona, United States
Dedicate Clinical Research, Inc.
Sun City, Arizona, United States
Central Arkansas Research
Hot Springs, Arkansas, United States
Research Solutions
Jonesboro, Arkansas, United States
Bay Area Foot Care
Castro Valley, California, United States
South Bay Clinical Research Inc.
Inglewood, California, United States
Pacific Sleep Medicine Services, Inc.
Los Angeles, California, United States
Pacific Sleep Medicine Services, Inc.
Palm Springs, California, United States
Northern California Research Group
Sacramento, California, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
Tampa Bay Medical Research
Clearwater, Florida, United States
University Clinical Research - DeLand
DeLand, Florida, United States
The Center for Diabetes and Endocrine Care
Hollywood, Florida, United States
FPA Clinical Research
Kissimmee, Florida, United States
Suncoast Neuroscience Associates, Inc.
St. Petersburg, Florida, United States
Neurology Clinical Research, Inc.
Sunrise, Florida, United States
Laszlo J. Mate, MD
West Palm Beach, Florida, United States
East-West Medical Research Institute
Honolulu, Hawaii, United States
Medisphere Medical Research Center, LLC
Evansville, Indiana, United States
Investigative Clinical Reserach of Indiana, LLC
Indianapolis, Indiana, United States
Crossroads Research, Inc.
Owings Mills, Maryland, United States
Medex Healthcare Research, Inc.
St Louis, Missouri, United States
Radiant Research - St. Louis
St Louis, Missouri, United States
Montana Neuroscience Institute
Missoula, Montana, United States
Creighton Diabetes Center
Omaha, Nebraska, United States
Advanced Biomedical Research of America
Las Vegas, Nevada, United States
Lovelace Scientific Resources
Albuquerque, New Mexico, United States
Upstate Clinical Research, LLC
Albany, New York, 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
Cincinnati, Ohio, 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
Radiant Research - Greer
Greer, South Carolina, United States
Radiant Research
Dallas, Texas, United States
Nerve & Muscle Center of Texas
Houston, Texas, United States
Diabetes & Glandular Disease Research Assoc.
San Antonio, Texas, United States
SAM Clinical Research
San Antonio, Texas, United States
Hampton Roads Center for Clinical Research
Norfolk, Virginia, United States
Tidewater Integrated Medical Research
Virginia Beach, Virginia, United States
University of Wisconsin Medical School
Madison, Wisconsin, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.1526-4637.2011.01316.x. Epub 2012 Feb 7.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
04-AVR-109
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.