Trials / Completed
CompletedNCT00004647
Phase III Randomized, Double-Blind, Placebo-Controlled Study of Mexiletine for Painful Diabetic Neuropathy
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 40 (planned)
- Sponsor
- National Center for Research Resources (NCRR) · NIH
- Sex
- All
- Age
- 21 Years – 60 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | mexiletine |
Timeline
- Start date
- 1993-03-01
- Completion
- 1999-02-01
- First posted
- 2000-02-25
- Last updated
- 2005-06-24
Source: ClinicalTrials.gov record NCT00004647. Inclusion in this directory is not an endorsement.