Phase III Randomized, Double-Blind, Placebo-Controlled Study of Mexiletine for Painful Diabetic Neuropathy
I. Assess the efficacy and toxicity of mexiletine in the management of paresthesias and pain in patients with diabetic neuropathy.
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Study Start Date:||March 1993|
|Estimated Study Completion Date:||February 1999|
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 Chair:||Tulio Bertorini||University of Tennessee|