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

This study has been completed.

First Received: February 24, 2000 Last Updated: June 23, 2005 History of Changes

Sponsor:	National Center for Research Resources (NCRR)
Collaborator:	University of Tennessee
Information provided by:	Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:	NCT00004647

Purpose

OBJECTIVES:

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

Condition	Intervention	Phase
Pain Diabetic Neuropathies Paresthesia	Drug: mexiletine	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind

Resource links provided by NLM:

MedlinePlus related topics: Diabetic Nerve Problems

Drug Information available for: Mexiletine Mexiletine hydrochloride

U.S. FDA Resources

Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment:	40
Study Start Date:	March 1993
Estimated Study Completion Date:	February 1999

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	21 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Patients with painful diabetic neuropathy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004647

Sponsors and Collaborators

National Center for Research Resources (NCRR)

University of Tennessee

Investigators

Study Chair:

Tulio Bertorini

University of Tennessee

More Information

Publications:

Bertorini TE, Alzagatiti BI, Horner LH, et al.: Electrophysiological effects of mexiletine in painful neuropathy. Nerve 21(11): 1576, 1998.

Study ID Numbers:	199/11702, UTENN-4686
Study First Received:	February 24, 2000
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00004647 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by Office of Rare Diseases (ORD):

diabetic neuropathy
disease-related problem/condition
neurologic and psychiatric disorders
pain
rare disease

Additional relevant MeSH terms:

Sensation Disorders
Diabetic Neuropathies
Nervous System Diseases
Diabetes Mellitus
Endocrine System Diseases
Mexiletine
Cardiovascular Agents
Pharmacologic Actions
Somatosensory Disorders

Signs and Symptoms
Neuromuscular Diseases
Therapeutic Uses
Paresthesia
Peripheral Nervous System Diseases
Neurologic Manifestations
Anti-Arrhythmia Agents
Diabetes Complications

ClinicalTrials.gov processed this record on November 27, 2009