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| 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 |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind |
| Estimated Enrollment: | 40 |
| Study Start Date: | March 1993 |
| Estimated Study Completion Date: | February 1999 |
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 |
Patients with painful diabetic neuropathy
Contacts and Locations| National Center for Research Resources (NCRR) |
| University of Tennessee |
| Study Chair: | Tulio Bertorini | University of Tennessee |
More Information
|
Bertorini TE, Alzagatiti BI, Horner LH, et al.: Electrophysiological effects
of mexiletine in painful neuropathy. Nerve 21(11): 1576, 1998.
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| Study ID Numbers: | 199/11702, UTENN-4686 |
| First Received: | February 24, 2000 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00004647 |
| Health Authority: | United States: Federal Government |
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