Phase III Randomized, Double-Blind, Placebo-Controlled Study of Mexiletine for Painful Diabetic Neuropathy

OBJECTIVES:

I. Assess the efficacy and toxicity of mexiletine in the management of paresthesias and pain in patients with diabetic neuropathy.

Completed

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Key information

Conditions

Pain Diabetes Complications Diabetes Mellitus Diabetic Neuropathies Disease Attributes Endocrine System Diseases Mental Disorders Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Paresthesia Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Rare Diseases Sensation Disorders Signs and Symptoms Somatosensory Disorders

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are stratified by participating institution.

The first group receives oral mexiletine 3 times a day for 6 weeks. The dose is increased after the first week if there are no side effects.

The second group receives a placebo. Patients cross to the alternate treatment after a 1-week washout.

Who can participate

Healthy volunteers accepted: No

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

Patients with painful diabetic neuropathy

Treatment and study plan

Mexiletine

Drug

Sponsors and collaborators

Lead sponsor

National Center for Research Resources (NCRR)

Nih

Collaborators

University of Tennessee

Registry information

Important dates

Study start: 1993
Study completion: 1999
First posted: Feb 25, 2000
Registry last updated: Jun 24, 2005

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