Phase III Randomized, Double-Blind, Placebo-Controlled Study of Mexiletine for Painful Diabetic Neuropathy
2 other identifiers
interventional
40
0 countries
N/A
Brief Summary
OBJECTIVES: I. Assess the efficacy and toxicity of mexiletine in the management of paresthesias and pain in patients with diabetic neuropathy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 pain
Started Mar 1993
Longer than P75 for phase_3 pain
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 1993
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 1999
CompletedFirst Submitted
Initial submission to the registry
February 24, 2000
CompletedFirst Posted
Study publicly available on registry
February 25, 2000
CompletedJune 24, 2005
March 1, 1999
February 24, 2000
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
Related Publications (1)
Bertorini TE, Alzagatiti BI, Horner LH, et al.: Electrophysiological effects of mexiletine in painful neuropathy. Nerve 21(11): 1576, 1998.
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Tulio Bertorini
University of Tennessee
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Sponsor Type
- NIH
Study Record Dates
First Submitted
February 24, 2000
First Posted
February 25, 2000
Study Start
March 1, 1993
Study Completion
February 1, 1999
Last Updated
June 24, 2005
Record last verified: 1999-03