Phase III Randomized, Double-Blind, Placebo-Controlled Study of Mexiletine for Painful Diabetic Neuropathy
Primary Purpose
Pain, Diabetic Neuropathies, Paresthesia
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
mexiletine
Sponsored by
About this trial
This is an interventional treatment trial for Pain focused on measuring diabetic neuropathy, disease-related problem/condition, neurologic and psychiatric disorders, pain, rare disease
Eligibility Criteria
Patients with painful diabetic neuropathy
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00004647
First Posted
February 24, 2000
Last Updated
June 23, 2005
Sponsor
National Center for Research Resources (NCRR)
Collaborators
University of Tennessee
1. Study Identification
Unique Protocol Identification Number
NCT00004647
Brief Title
Phase III Randomized, Double-Blind, Placebo-Controlled Study of Mexiletine for Painful Diabetic Neuropathy
Study Type
Interventional
2. Study Status
Record Verification Date
March 1999
Overall Recruitment Status
Completed
Study Start Date
March 1993 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 1999 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Center for Research Resources (NCRR)
Collaborators
University of Tennessee
4. Oversight
5. Study Description
Brief Summary
OBJECTIVES:
I. Assess the efficacy and toxicity of mexiletine in the management of paresthesias and pain in patients with diabetic neuropathy.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Diabetic Neuropathies, Paresthesia
Keywords
diabetic neuropathy, disease-related problem/condition, neurologic and psychiatric disorders, pain, rare disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Masking
Double
Allocation
Randomized
Enrollment
40 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
mexiletine
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Patients with painful diabetic neuropathy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tulio Bertorini
Organizational Affiliation
University of Tennessee
Official's Role
Study Chair
12. IPD Sharing Statement
Citations:
Citation
Bertorini TE, Alzagatiti BI, Horner LH, et al.: Electrophysiological effects of mexiletine in painful neuropathy. Nerve 21(11): 1576, 1998.
Results Reference
background
Learn more about this trial
Phase III Randomized, Double-Blind, Placebo-Controlled Study of Mexiletine for Painful Diabetic Neuropathy
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