Safety and Efficacy of Dextromethorphan and Quinidine in the Treatment of the Pain of Diabetic Neuropathy - Full Text View

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

MedlinePlus related topics:

Diabetic Nerve Problems

ChemIDplus related topics:

Dextromethorphan Dextromethorphan hydrobromide Levomethorphan Racemethorphan Quinidine Avp 923

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

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

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

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

Keywords provided by Avanir Pharmaceuticals:

distal symmetrical

pain

lower extremities

dextromethorphan

Study placed in the following topic categories:

Excitatory Amino Acids

Diabetic Neuropathies

Diabetes Mellitus

Endocrine System Diseases

Pain

Naphazoline

Oxymetazoline

Neuromuscular Diseases

Guaifenesin

Phenylephrine

Peripheral Nervous System Diseases

Quinidine

Dextromethorphan

Phenylpropanolamine

Endocrinopathy

Diabetes Complications

Additional relevant MeSH terms:

Anti-Infective Agents

Respiratory System Agents

Antiprotozoal Agents

Neurotransmitter Agents

Cholinergic Antagonists

Adrenergic Agents

Molecular Mechanisms of Pharmacological Action

Nervous System Diseases

Physiological Effects of Drugs

Enzyme Inhibitors

Excitatory Amino Acid Agents

Adrenergic alpha-Antagonists

Cardiovascular Agents

Cholinergic Agents

Pharmacologic Actions

Muscarinic Antagonists

Antimalarials

Antiparasitic Agents

Therapeutic Uses

Adrenergic Antagonists

Anti-Arrhythmia Agents

Antitussive Agents

Central Nervous System Agents

Excitatory Amino Acid Antagonists

ClinicalTrials.gov processed this record on October 03, 2008

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