Study 3 of 11 for search of: "Paresthesia"
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Phase III Randomized, Double-Blind, Placebo-Controlled Study of Mexiletine for Painful Diabetic Neuropathy
This study has been completed.
Sponsors and Collaborators: National Center for Research Resources (NCRR)
University of Tennessee
Information provided by: Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier: NCT00004647
  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 III

MedlinePlus related topics: Diabetic Nerve Problems
Drug Information available for: Mexiletine Mexiletine hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind

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
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.

Study ID Numbers: 199/11702, UTENN-4686
Study First Received: February 24, 2000
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00004647  
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

Study placed in the following topic categories:
Sensation Disorders
Diabetic Neuropathies
Rare Diseases
Diabetes Mellitus
Endocrine System Diseases
Mexiletine
Pain
Signs and Symptoms
Somatosensory Disorders
Neuromuscular Diseases
Mental Disorders
Paresthesia
Peripheral Nervous System Diseases
Neurologic Manifestations
Endocrinopathy
Diabetes Complications

Additional relevant MeSH terms:
Therapeutic Uses
Nervous System Diseases
Cardiovascular Agents
Anti-Arrhythmia Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009