- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00004647
Phase III Randomized, Double-Blind, Placebo-Controlled Study of Mexiletine for Painful Diabetic Neuropathy
OBJECTIVES:
I. Assess the efficacy and toxicity of mexiletine in the management of paresthesias and pain in patients with diabetic neuropathy.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment
Phase
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Masking: DOUBLE
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Tulio Bertorini, University of Tennessee
Publications and helpful links
General Publications
- Bertorini TE, Alzagatiti BI, Horner LH, et al.: Electrophysiological effects of mexiletine in painful neuropathy. Nerve 21(11): 1576, 1998.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neurologic Manifestations
- Endocrine System Diseases
- Diabetes Complications
- Diabetes Mellitus
- Neuromuscular Diseases
- Peripheral Nervous System Diseases
- Sensation Disorders
- Somatosensory Disorders
- Diabetic Neuropathies
- Paresthesia
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Membrane Transport Modulators
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Mexiletine
Other Study ID Numbers
- 199/11702
- UTENN-4686
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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