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

This study has been completed.
Sponsor:
Collaborator:
University of Tennessee
Information provided by:
Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:
NCT00004647
First received: February 24, 2000
Last updated: June 23, 2005
Last verified: March 1999
History of Changes
  Purpose

OBJECTIVES:

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


Condition Intervention Phase
Pain
Diabetic Neuropathies
Paresthesia
 Drug: mexiletine
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment: 40
Study Start Date: March 1993
Estimated Study Completion Date: February 1999
Detailed 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.

  Eligibility

Ages Eligible for Study:   21 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Patients with painful diabetic neuropathy

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004647

Sponsors and Collaborators
National Center for Research Resources (NCRR)
University of Tennessee
Investigators
Study Chair: Tulio Bertorini University of Tennessee
  More Information

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

ClinicalTrials.gov Identifier: NCT00004647     History of Changes
Other Study ID Numbers: 199/11702, UTENN-4686
Study First Received: February 24, 2000
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Keywords provided by Office of Rare Diseases (ORD):
diabetic neuropathy
disease-related problem/condition
neurologic and psychiatric disorders
pain
rare disease

Additional relevant MeSH terms:
Paresthesia
Diabetic Neuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Somatosensory Disorders
 Sensation Disorders
Neurologic Manifestations
Signs and Symptoms
Mexiletine
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013