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: May 5, 2014
Last verified: May 2014
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 44 Study Locations
Sponsors and Collaborators
Avanir Pharmaceuticals
  More Information

Publications:
ClinicalTrials.gov 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
pain
lower extremities
dextromethorphan

Additional relevant MeSH terms:
Diabetic Neuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Dextromethorphan
Quinidine
Antitussive Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Respiratory System Agents
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Anti-Arrhythmia Agents
Cardiovascular Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Muscarinic Antagonists

ClinicalTrials.gov processed this record on September 22, 2014