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

This study has been completed.
Information provided by:
Avanir Pharmaceuticals Identifier:
First received: June 9, 2005
Last updated: May 5, 2014
Last verified: May 2014
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
Diabetic Neuropathy
Drug: Neurodex
Phase 3

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:

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts 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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Please refer to this study by its identifier: NCT00113620

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Sponsors and Collaborators
Avanir Pharmaceuticals
  More Information

Publications: Identifier: NCT00113620     History of Changes
Other Study ID Numbers: 04-AVR-109 
Study First Received: June 9, 2005
Last Updated: May 5, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Avanir Pharmaceuticals:
distal symmetrical
lower extremities

Additional relevant MeSH terms:
Diabetic Neuropathies
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Nervous System Diseases
Neuromuscular Diseases
Peripheral Nervous System Diseases
Adrenergic Agents
Adrenergic Antagonists
Adrenergic alpha-Antagonists
Anti-Arrhythmia Agents
Anti-Infective Agents
Antiparasitic Agents
Antiprotozoal Agents
Antitussive Agents
Cardiovascular Agents
Central Nervous System Agents
Cholinergic Agents
Cholinergic Antagonists
Enzyme Inhibitors
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Neurotransmitter Agents
Pharmacologic Actions processed this record on February 08, 2016