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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

1993-03-31

Study Completion Date

1999-02-28

Brief Summary

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OBJECTIVES:

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

Detailed Description

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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.

Conditions

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Pain Diabetic Neuropathies Paresthesia

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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mexiletine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Patients with painful diabetic neuropathy

Minimum Eligible Age

21 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Tulio Bertorini

Role: STUDY_CHAIR

University of Tennessee

References

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

Reference Type BACKGROUND

Other Identifiers

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UTENN-4686

Identifier Type: -

Identifier Source: secondary_id

199/11702