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Clinical Trial Summary

OBJECTIVES:

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


Clinical Trial 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 Design

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00004647
Study type Interventional
Source Office of Rare Diseases (ORD)
Contact
Status Completed
Phase Phase 3
Start date March 1993
Completion date February 1999

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