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NCT00004647 Clinical Trial

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

Pain Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00004647
Other study ID # 199/11702
Secondary ID UTENN-4686
Status Completed
Phase Phase 3
First received February 24, 2000
Last updated June 23, 2005
Start date March 1993
Est. completion date February 1999

Study information
Verified date March 1999
Source Office of Rare Diseases (ORD)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

OBJECTIVES:

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date February 1999
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 21 Years to 60 Years
Eligibility Patients with painful diabetic neuropathy

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• mexiletine

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
National Center for Research Resources (NCRR) University of Tennessee

References & Publications (1)

Bertorini TE, Alzagatiti BI, Horner LH, et al.: Electrophysiological effects of mexiletine in painful neuropathy. Nerve 21(11): 1576, 1998.

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