Phase III Randomized, Double-Blind, Placebo-Controlled Study of Mexiletine for Painful Diabetic Neuropathy
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|ClinicalTrials.gov Identifier: NCT00004647|
Recruitment Status : Completed
First Posted : February 25, 2000
Last Update Posted : June 24, 2005
I. Assess the efficacy and toxicity of mexiletine in the management of paresthesias and pain in patients with diabetic neuropathy.
|Condition or disease||Intervention/treatment||Phase|
|Pain Diabetic Neuropathies Paresthesia||Drug: mexiletine||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Study Start Date :||March 1993|
|Estimated Study Completion Date :||February 1999|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004647
|Study Chair:||Tulio Bertorini||University of Tennessee|