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

This study has been completed.

First Received on June 9, 2005. Last Updated on December 26, 2007 History of Changes

Sponsor:	Avanir Pharmaceuticals
Information provided by:	Avanir Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00113620

Purpose

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

Condition	Intervention	Phase
Pain Diabetic Neuropathy	Drug: Neurodex	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind 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

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus Charcot-Marie-Tooth disease hereditary neuropathy with liability to pressure palsies

MedlinePlus related topics: Diabetic Nerve Problems

Drug Information available for: Quinidine sulfate Quinidine Dextromethorphan hydrochloride Quinidine polygalacturonate Levomethorphan Dextromethorphan Racemethorphan Dextromethorphan hydrobromide Quinidine gluconate

U.S. FDA Resources

Further study details as provided by Avanir Pharmaceuticals:

Primary Outcome Measures:

Pain rating scale obtained from patient diaries

Secondary Outcome Measures:

Additional diary rating scales and scores obtained from clinic visits

Estimated Enrollment:	450
Study Start Date:	July 2005
Estimated Study Completion Date:	December 2006

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00113620

Show 44 Study Locations

Sponsors and Collaborators

Avanir Pharmaceuticals

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00113620 History of Changes
Other Study ID Numbers:	04-AVR-109
Study First Received:	June 9, 2005
Last Updated:	December 26, 2007
Health Authority:	United States: Food and Drug Administration

Keywords provided by Avanir Pharmaceuticals:

distal symmetrical
pain
lower extremities
dextromethorphan

Additional relevant MeSH terms:

Diabetic Neuropathies
Demyelinating Diseases
Polyneuropathies
Nerve Compression Syndromes
Neurologic Manifestations
Neurotoxicity Syndromes
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Signs and Symptoms
Poisoning
Substance-Related Disorders

Dextromethorphan
Quinidine
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antitussive Agents
Central Nervous System Agents
Therapeutic Uses
Respiratory System Agents
Anti-Arrhythmia Agents
Cardiovascular Agents
Adrenergic alpha-Antagonists

ClinicalTrials.gov processed this record on February 12, 2012