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

Information source: Avanir Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pain; Diabetic Neuropathy

Intervention: Neurodex (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Avanir Pharmaceuticals

Summary

The purpose of this study is to determine whether dextromethorphan (Neurodex) and quinidine are effective in the treatment of pain of diabetic neuropathy.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: Pain rating scale obtained from patient diaries

Secondary outcome: Additional diary rating scales and scores obtained from clinic visits

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

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

Locations and Contacts

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

Additional Information

Starting date: July 2005
Last updated: May 5, 2014

Page last updated: August 23, 2015

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