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COMPLETEDPhase 3NCT00113620

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

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

Lead sponsor: Avanir Pharmaceuticals•44 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Avanir Pharmaceuticals

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

No

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: July 14, 2016Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE3

Enrollment450

Start dateJul 2005

Last updatedJul 14, 2016

Condition

Pain Diabetic Neuropathy

Locations shown

Pivotal Research Centers

Mesa, Arizona

Dedicate Clinical Research, Inc.

Sun City, Arizona

Central Arkansas Research

Hot Springs, Arkansas

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 14, 2016Data synced to Clareo: May 17, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions