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

Primary Purpose

Pain, Diabetic Neuropathy

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Neurodex
Sponsored by
Avanir Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring distal symmetrical, pain, lower extremities, dextromethorphan

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pivotal Research Centers
  • Dedicate Clinical Research, Inc.
  • Central Arkansas Research
  • Research Solutions
  • Bay Area Foot Care
  • South Bay Clinical Research Inc.
  • Pacific Sleep Medicine Services, Inc.
  • Pacific Sleep Medicine Services, Inc.
  • Northern California Research Group
  • Diablo Clinical Research, Inc.
  • Tampa Bay Medical Research
  • University Clinical Research - DeLand
  • The Center for Diabetes and Endocrine Care
  • FPA Clinical Research
  • Suncoast Neuroscience Associates, Inc.
  • Neurology Clinical Research, Inc.
  • Laszlo J. Mate, MD
  • East-West Medical Research Institute
  • Medisphere Medical Research Center, LLC
  • Investigative Clinical Reserach of Indiana, LLC
  • Crossroads Research, Inc.
  • Medex Healthcare Research, Inc.
  • Radiant Research - St. Louis
  • Montana Neuroscience Institute
  • Creighton Diabetes Center
  • Advanced Biomedical Research of America
  • Lovelace Scientific Resources
  • Upstate Clinical Research, LLC
  • DiGiovanna Family Care Center
  • Weill Medical College of Cornell University - Peripheral Neuropathy Center
  • Vital Research
  • Radiant Research
  • Radiant Research - Akron
  • Neurology & Neuroscience Center of Ohio
  • Knights Road Medical
  • Omega Medical Research
  • Radiant Research - Greer
  • Radiant Research
  • Nerve & Muscle Center of Texas
  • Diabetes & Glandular Disease Research Assoc.
  • SAM Clinical Research
  • Hampton Roads Center for Clinical Research
  • Tidewater Integrated Medical Research
  • University of Wisconsin Medical School

Outcomes

Primary Outcome Measures

Pain rating scale obtained from patient diaries

Secondary Outcome Measures

Additional diary rating scales and scores obtained from clinic visits

Full Information

First Posted
June 9, 2005
Last Updated
July 13, 2016
Sponsor
Avanir Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00113620
Brief Title
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

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
February 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Avanir Pharmaceuticals

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Diabetic Neuropathy
Keywords
distal symmetrical, pain, lower extremities, dextromethorphan

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
450 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Neurodex
Primary Outcome Measure Information:
Title
Pain rating scale obtained from patient diaries
Secondary Outcome Measure Information:
Title
Additional diary rating scales and scores obtained from clinic visits

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Pivotal Research Centers
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85210
Country
United States
Facility Name
Dedicate Clinical Research, Inc.
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85351
Country
United States
Facility Name
Central Arkansas Research
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
Research Solutions
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
Bay Area Foot Care
City
Castro Valley
State/Province
California
ZIP/Postal Code
94546
Country
United States
Facility Name
South Bay Clinical Research Inc.
City
Inglewood
State/Province
California
ZIP/Postal Code
90301
Country
United States
Facility Name
Pacific Sleep Medicine Services, Inc.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Pacific Sleep Medicine Services, Inc.
City
Palm Springs
State/Province
California
ZIP/Postal Code
92262
Country
United States
Facility Name
Northern California Research Group
City
Sacramento
State/Province
California
ZIP/Postal Code
95831
Country
United States
Facility Name
Diablo Clinical Research, Inc.
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Tampa Bay Medical Research
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33761
Country
United States
Facility Name
University Clinical Research - DeLand
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
The Center for Diabetes and Endocrine Care
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
FPA Clinical Research
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
Facility Name
Suncoast Neuroscience Associates, Inc.
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
Facility Name
Neurology Clinical Research, Inc.
City
Sunrise
State/Province
Florida
ZIP/Postal Code
33351
Country
United States
Facility Name
Laszlo J. Mate, MD
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
East-West Medical Research Institute
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96814
Country
United States
Facility Name
Medisphere Medical Research Center, LLC
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Investigative Clinical Reserach of Indiana, LLC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46254
Country
United States
Facility Name
Crossroads Research, Inc.
City
Owings Mills
State/Province
Maryland
ZIP/Postal Code
21117
Country
United States
Facility Name
Medex Healthcare Research, Inc.
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63117
Country
United States
Facility Name
Radiant Research - St. Louis
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Montana Neuroscience Institute
City
Missoula
State/Province
Montana
ZIP/Postal Code
59802
Country
United States
Facility Name
Creighton Diabetes Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
Advanced Biomedical Research of America
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89123
Country
United States
Facility Name
Lovelace Scientific Resources
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87108
Country
United States
Facility Name
Upstate Clinical Research, LLC
City
Albany
State/Province
New York
ZIP/Postal Code
12205
Country
United States
Facility Name
DiGiovanna Family Care Center
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Weill Medical College of Cornell University - Peripheral Neuropathy Center
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Facility Name
Vital Research
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27408
Country
United States
Facility Name
Radiant Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States
Facility Name
Radiant Research - Akron
City
Mogadore
State/Province
Ohio
ZIP/Postal Code
44260
Country
United States
Facility Name
Neurology & Neuroscience Center of Ohio
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623
Country
United States
Facility Name
Knights Road Medical
City
Bensalem
State/Province
Pennsylvania
ZIP/Postal Code
19020
Country
United States
Facility Name
Omega Medical Research
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
Radiant Research - Greer
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
Radiant Research
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Nerve & Muscle Center of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Diabetes & Glandular Disease Research Assoc.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
SAM Clinical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Hampton Roads Center for Clinical Research
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Tidewater Integrated Medical Research
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23451
Country
United States
Facility Name
University of Wisconsin Medical School
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22314263
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.
Results Reference
result

Learn more about this trial

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

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