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

National Center for Research Resources (NCRR)

Status and phase: Completed; Phase 3

Conditions: Paresthesia; Diabetic Neuropathies; Pain

Treatments: Drug: mexiletine

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00004647

199/11702

UTENN-4686

Details and patient eligibility

About

OBJECTIVES:

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

Full 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.

Sex: All

Ages: 21 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Patients with painful diabetic neuropathy