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

Tracking Information

First Received Date ^ICMJE

February 24, 2000

Last Updated Date

June 23, 2005

Start Date ^ICMJE

March 1993

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00004647 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Brief Summary

OBJECTIVES:

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

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.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind

Condition ^ICMJE

Pain
Diabetic Neuropathies
Paresthesia

Intervention ^ICMJE

Drug: mexiletine

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

February 1999

Primary Completion Date

Eligibility Criteria ^ICMJE

Patients with painful diabetic neuropathy

Gender

Both

Ages

21 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00004647

Responsible Party

Study ID Numbers ^ICMJE

199/11702, UTENN-4686

Study Sponsor ^ICMJE

National Center for Research Resources (NCRR)

Collaborators ^ICMJE

University of Tennessee

Investigators ^ICMJE

Study Chair:

Tulio Bertorini

University of Tennessee

Information Provided By

Office of Rare Diseases (ORD)

Verification Date

March 1999

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP