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CompletedNCT00004647Updated Jun 24, 2005

Phase III Randomized, Double-Blind, Placebo-Controlled Study of Mexiletine for Painful Diabetic Neuropathy

A Phase 3 interventional study of mexiletine in Pain, Diabetic Neuropathies and Paresthesia, sponsored by National Center for Research Resources (NCRR). Completed. Open to participants aged 21 Years to 60 Years. Per ClinicalTrials.gov, last updated 2005-06-24.

Sponsored by National Center for Research Resources (NCRR) · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
21 Years to 60 Years
Sex
All
01

Study summary

OBJECTIVES:

I. Assess the efficacy and toxicity of mexiletine in the management of paresthesias and pain in patients with diabetic neuropathy.

Read the 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.

02

Conditions studied

  • Pain
  • Diabetic Neuropathies
  • Paresthesia

Keywords

  • diabetic neuropathy
  • disease-related problem/condition
  • neurologic and psychiatric disorders
  • pain
  • rare disease
03

In context

Pain

10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.

This study's enrollment of 40 is below the median of 66 across 8,493 interventional studies indexed under Pain.

Browse Pain studies →

Lead sponsor

National Center for Research Resources (NCRR) is the lead sponsor of 265 studies on the registry; none are open to participants now.

Browse National Center for Research Resources (NCRR) studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Patients with painful diabetic neuropathy

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Masking
Double
Enrollment
40 participants

Interventions

06

Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • Bertorini TE, Alzagatiti BI, Horner LH, et al.: Electrophysiological effects of mexiletine in painful neuropathy. Nerve 21(11): 1576, 1998.
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2005, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00004647
Lead sponsor
National Center for Research Resources (NCRR)
Collaborators
University of Tennessee
First posted
Feb 25, 2000
Start date
Mar 1993
Completion
Feb 1999
Last update
Jun 24, 2005

Study contacts

Tulio Bertorini
study chair · University of Tennessee
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 1999. You cannot join it, but the record below documents what was studied.

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