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

Sponsor

Avanir Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00113620

Collaborator

(none)

450

Enrollment

Locations

19.1

Duration (Months)

10.2

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pain Diabetic Neuropathy	Drug: Neurodex	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

450 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

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 Start Date :

Jul 1, 2005

Actual Primary Completion Date :

Feb 1, 2007

Actual Study Completion Date :

Feb 1, 2007

Outcome Measures

Primary Outcome Measures

Pain rating scale obtained from patient diaries []

Secondary Outcome Measures

Additional diary rating scales and scores obtained from clinic visits []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pivotal Research Centers	Mesa	Arizona	United States	85210
2	Dedicate Clinical Research, Inc.	Sun City	Arizona	United States	85351
3	Central Arkansas Research	Hot Springs	Arkansas	United States	71913
4	Research Solutions	Jonesboro	Arkansas	United States	72401
5	Bay Area Foot Care	Castro Valley	California	United States	94546
6	South Bay Clinical Research Inc.	Inglewood	California	United States	90301
7	Pacific Sleep Medicine Services, Inc.	Los Angeles	California	United States	90048
8	Pacific Sleep Medicine Services, Inc.	Palm Springs	California	United States	92262
9	Northern California Research Group	Sacramento	California	United States	95831
10	Diablo Clinical Research, Inc.	Walnut Creek	California	United States	94598
11	Tampa Bay Medical Research	Clearwater	Florida	United States	33761
12	University Clinical Research - DeLand	DeLand	Florida	United States	32720
13	The Center for Diabetes and Endocrine Care	Hollywood	Florida	United States	33021
14	FPA Clinical Research	Kissimmee	Florida	United States	34741
15	Suncoast Neuroscience Associates, Inc.	St. Petersburg	Florida	United States	33701
16	Neurology Clinical Research, Inc.	Sunrise	Florida	United States	33351
17	Laszlo J. Mate, MD	West Palm Beach	Florida	United States	33407
18	East-West Medical Research Institute	Honolulu	Hawaii	United States	96814
19	Medisphere Medical Research Center, LLC	Evansville	Indiana	United States	47714
20	Investigative Clinical Reserach of Indiana, LLC	Indianapolis	Indiana	United States	46254
21	Crossroads Research, Inc.	Owings Mills	Maryland	United States	21117
22	Medex Healthcare Research, Inc.	St. Louis	Missouri	United States	63117
23	Radiant Research - St. Louis	St. Louis	Missouri	United States	63141
24	Montana Neuroscience Institute	Missoula	Montana	United States	59802
25	Creighton Diabetes Center	Omaha	Nebraska	United States	68131
26	Advanced Biomedical Research of America	Las Vegas	Nevada	United States	89123
27	Lovelace Scientific Resources	Albuquerque	New Mexico	United States	87108
28	Upstate Clinical Research, LLC	Albany	New York	United States	12205
29	DiGiovanna Family Care Center	Great Neck	New York	United States	11021
30	Weill Medical College of Cornell University - Peripheral Neuropathy Center	New York	New York	United States	10022
31	Vital Research	Greensboro	North Carolina	United States	27408
32	Radiant Research	Cincinnati	Ohio	United States	45236
33	Radiant Research - Akron	Mogadore	Ohio	United States	44260
34	Neurology & Neuroscience Center of Ohio	Toledo	Ohio	United States	43623
35	Knights Road Medical	Bensalem	Pennsylvania	United States	19020
36	Omega Medical Research	Warwick	Rhode Island	United States	02886
37	Radiant Research - Greer	Greer	South Carolina	United States	29651
38	Radiant Research	Dallas	Texas	United States	75231
39	Nerve & Muscle Center of Texas	Houston	Texas	United States	77030
40	Diabetes & Glandular Disease Research Assoc.	San Antonio	Texas	United States	78229
41	SAM Clinical Research	San Antonio	Texas	United States	78229
42	Hampton Roads Center for Clinical Research	Norfolk	Virginia	United States	23502
43	Tidewater Integrated Medical Research	Virginia Beach	Virginia	United States	23451
44	University of Wisconsin Medical School	Madison	Wisconsin	United States	53792