Clinical trial NCT00113620: Safety and Efficacy of Dextromethorphan and Quinidine in the Treatment of the Pain of Diabetic Neuropathy
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Diabetic Neuropathy
Keywords: distal symmetrical
pain
lower extremities
dextromethorphan
Lead sponsor: Avanir Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-06-10
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Pain rating scale obtained from patient diaries
Secondary outcomes:
measure: Additional diary rating scales and scores obtained from clinic visits
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Pivotal Research Centers
state: Arizona
city: Sun City
country: United States
facility: Dedicate Clinical Research, Inc.
state: Arizona
city: Hot Springs
country: United States
facility: Central Arkansas Research
state: Arkansas
city: Jonesboro
country: United States
facility: Research Solutions
state: Arkansas
city: Castro Valley
country: United States
facility: Bay Area Foot Care
state: California
city: Inglewood
country: United States
facility: South Bay Clinical Research Inc.
state: California
city: Los Angeles
country: United States
facility: Pacific Sleep Medicine Services, Inc.
state: California
city: Palm Springs
country: United States
facility: Pacific Sleep Medicine Services, Inc.
state: California
city: Sacramento
country: United States
facility: Northern California Research Group
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research, Inc.
state: California
city: Clearwater
country: United States
facility: Tampa Bay Medical Research
state: Florida
city: DeLand
country: United States
facility: University Clinical Research - DeLand
state: Florida
city: Hollywood
country: United States
facility: The Center for Diabetes and Endocrine Care
state: Florida
city: Kissimmee
country: United States
facility: FPA Clinical Research
state: Florida
city: St. Petersburg
country: United States
facility: Suncoast Neuroscience Associates, Inc.
state: Florida
city: Sunrise
country: United States
facility: Neurology Clinical Research, Inc.
state: Florida
city: West Palm Beach
country: United States
facility: Laszlo J. Mate, MD
state: Florida
city: Honolulu
country: United States
facility: East-West Medical Research Institute
state: Hawaii
city: Evansville
country: United States
facility: Medisphere Medical Research Center, LLC
state: Indiana
city: Indianapolis
country: United States
facility: Investigative Clinical Reserach of Indiana, LLC
state: Indiana
city: Owings Mills
country: United States
facility: Crossroads Research, Inc.
state: Maryland
city: St. Louis
country: United States
facility: Medex Healthcare Research, Inc.
state: Missouri
city: St. Louis
country: United States
facility: Radiant Research - St. Louis
state: Missouri
city: Missoula
country: United States
facility: Montana Neuroscience Institute
state: Montana
city: Omaha
country: United States
facility: Creighton Diabetes Center
state: Nebraska
city: Las Vegas
country: United States
facility: Advanced Biomedical Research of America
state: Nevada
city: Albuquerque
country: United States
facility: Lovelace Scientific Resources
state: New Mexico
city: Albany
country: United States
facility: Upstate Clinical Research, LLC
state: New York
city: Great Neck
country: United States
facility: DiGiovanna Family Care Center
state: New York
city: New York
country: United States
facility: Weill Medical College of Cornell University - Peripheral Neuropathy Center
state: New York
city: Greensboro
country: United States
facility: Vital Research
state: North Carolina
city: Cincinnati
country: United States
facility: Radiant Research
state: Ohio
city: Mogadore
country: United States
facility: Radiant Research - Akron
state: Ohio
city: Toledo
country: United States
facility: Neurology & Neuroscience Center of Ohio
state: Ohio
city: Bensalem
country: United States
facility: Knights Road Medical
state: Pennsylvania
city: Warwick
country: United States
facility: Omega Medical Research
state: Rhode Island
city: Greer
country: United States
facility: Radiant Research - Greer
state: South Carolina
city: Dallas
country: United States
facility: Radiant Research
state: Texas
city: Houston
country: United States
facility: Nerve & Muscle Center of Texas
state: Texas
city: San Antonio
country: United States
facility: Diabetes & Glandular Disease Research Assoc.
state: Texas
city: San Antonio
country: United States
facility: SAM Clinical Research
state: Texas
city: Norfolk
country: United States
facility: Hampton Roads Center for Clinical Research
state: Virginia
city: Virginia Beach
country: United States
facility: Tidewater Integrated Medical Research
state: Virginia
city: Madison
country: United States
facility: University of Wisconsin Medical School
state: Wisconsin
Study officials:
References:
citation: 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.