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

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

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Key information

Conditions

Pain Diabetes Complications Diabetes Mellitus Diabetic Neuropathies Diabetic Neuropathy Endocrine System Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pivotal Research Centers, Mesa, Arizona, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neurodex

Drug

Primary outcomes

Pain rating scale obtained from patient diaries

Secondary outcomes

Additional diary rating scales and scores obtained from clinic visits

Sponsors and collaborators

Lead sponsor

Avanir Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start: 2005
Primary completion: 2007
Study completion: 2007
First posted: Jun 10, 2005
Registry last updated: Jul 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed