Safety and Efficacy of Dextromethorphan and Quinidine in the Treatment of the Pain of Diabetic Neuropathy
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
1 other identifier
interventional
450
1 country
44
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 pain
Started Jul 2005
Typical duration for phase_3 pain
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 9, 2005
CompletedFirst Posted
Study publicly available on registry
June 10, 2005
CompletedStudy Start
First participant enrolled
July 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2007
CompletedJuly 14, 2016
July 1, 2016
1.6 years
June 9, 2005
July 13, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain rating scale obtained from patient diaries
Secondary Outcomes (1)
Additional diary rating scales and scores obtained from clinic visits
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (44)
Pivotal Research Centers
Mesa, Arizona, 85210, United States
Dedicate Clinical Research, Inc.
Sun City, Arizona, 85351, United States
Central Arkansas Research
Hot Springs, Arkansas, 71913, United States
Research Solutions
Jonesboro, Arkansas, 72401, United States
Bay Area Foot Care
Castro Valley, California, 94546, United States
South Bay Clinical Research Inc.
Inglewood, California, 90301, United States
Pacific Sleep Medicine Services, Inc.
Los Angeles, California, 90048, United States
Pacific Sleep Medicine Services, Inc.
Palm Springs, California, 92262, United States
Northern California Research Group
Sacramento, California, 95831, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598, United States
Tampa Bay Medical Research
Clearwater, Florida, 33761, United States
University Clinical Research - DeLand
DeLand, Florida, 32720, United States
The Center for Diabetes and Endocrine Care
Hollywood, Florida, 33021, United States
FPA Clinical Research
Kissimmee, Florida, 34741, United States
Suncoast Neuroscience Associates, Inc.
St. Petersburg, Florida, 33701, United States
Neurology Clinical Research, Inc.
Sunrise, Florida, 33351, United States
Laszlo J. Mate, MD
West Palm Beach, Florida, 33407, United States
East-West Medical Research Institute
Honolulu, Hawaii, 96814, United States
Medisphere Medical Research Center, LLC
Evansville, Indiana, 47714, United States
Investigative Clinical Reserach of Indiana, LLC
Indianapolis, Indiana, 46254, United States
Crossroads Research, Inc.
Owings Mills, Maryland, 21117, United States
Medex Healthcare Research, Inc.
St Louis, Missouri, 63117, United States
Radiant Research - St. Louis
St Louis, Missouri, 63141, United States
Montana Neuroscience Institute
Missoula, Montana, 59802, United States
Creighton Diabetes Center
Omaha, Nebraska, 68131, United States
Advanced Biomedical Research of America
Las Vegas, Nevada, 89123, United States
Lovelace Scientific Resources
Albuquerque, New Mexico, 87108, United States
Upstate Clinical Research, LLC
Albany, New York, 12205, United States
DiGiovanna Family Care Center
Great Neck, New York, 11021, United States
Weill Medical College of Cornell University - Peripheral Neuropathy Center
New York, New York, 10022, United States
Vital Research
Greensboro, North Carolina, 27408, United States
Radiant Research
Cincinnati, Ohio, 45236, United States
Radiant Research - Akron
Mogadore, Ohio, 44260, United States
Neurology & Neuroscience Center of Ohio
Toledo, Ohio, 43623, United States
Knights Road Medical
Bensalem, Pennsylvania, 19020, United States
Omega Medical Research
Warwick, Rhode Island, 02886, United States
Radiant Research - Greer
Greer, South Carolina, 29651, United States
Radiant Research
Dallas, Texas, 75231, United States
Nerve & Muscle Center of Texas
Houston, Texas, 77030, United States
Diabetes & Glandular Disease Research Assoc.
San Antonio, Texas, 78229, United States
SAM Clinical Research
San Antonio, Texas, 78229, United States
Hampton Roads Center for Clinical Research
Norfolk, Virginia, 23502, United States
Tidewater Integrated Medical Research
Virginia Beach, Virginia, 23451, United States
University of Wisconsin Medical School
Madison, Wisconsin, 53792, United States
Related 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.1526-4637.2011.01316.x. Epub 2012 Feb 7.
PMID: 22314263RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 9, 2005
First Posted
June 10, 2005
Study Start
July 1, 2005
Primary Completion
February 1, 2007
Study Completion
February 1, 2007
Last Updated
July 14, 2016
Record last verified: 2016-07