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

This study has been completed.
Sponsor:
Information provided by:
Avanir Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00113620
First received: June 9, 2005
Last updated: December 26, 2007
Last verified: December 2007
History of Changes
  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 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:

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 May 22, 2013