Phase III Randomized, Double-Blind, Placebo-Controlled Study of Mexiletine for Painful Diabetic Neuropathy
NCT00004647 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2005-06-24
Summary
OBJECTIVES:
I. Assess the efficacy and toxicity of mexiletine in the management of paresthesias and pain in patients with diabetic neuropathy.
Conditions
- Pain
- Diabetic Neuropathies
- Paresthesia
Interventions
- DRUG
-
mexiletine
Sponsors & Collaborators
-
University of Tennessee
collaborator OTHER -
National Center for Research Resources (NCRR)
lead NIH
Principal Investigators
-
Tulio Bertorini · University of Tennessee
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
Eligibility
- Min Age
- 21 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 1993-03-31
- Completion
- 1999-02-28
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