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

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

This study has been completed.

Sponsors and Collaborators:	National Center for Research Resources (NCRR) 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

MedlinePlus related topics:

Diabetic Nerve Problems

Drug Information available for:

Mexiletine Mexiletine hydrochloride

U.S. FDA Resources

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

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
First Received:	February 24, 2000
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00004647
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

Study placed in the following topic categories:

Sensation Disorders

Diabetic Neuropathies

Rare Diseases

Diabetes Mellitus

Endocrine System Diseases

Mexiletine

Pain

Signs and Symptoms

Somatosensory Disorders

Neuromuscular Diseases

Mental Disorders

Paresthesia

Peripheral Nervous System Diseases

Neurologic Manifestations

Endocrinopathy

Diabetes Complications

Additional relevant MeSH terms:

Therapeutic Uses

Nervous System Diseases

Cardiovascular Agents

Anti-Arrhythmia Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on November 30, 2008