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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00004647

Enrollment

Registered

2000-02-25

Start date

1993-03-31

Completion date

1999-02-28

Last updated

2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Neuropathies, Pain, Paresthesia

Keywords

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

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.

Interventions

DRUGmexiletine

Study design

Allocation

RANDOMIZED

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

21 Years to 60 Years

Healthy volunteers

Inclusion criteria

Patients with painful diabetic neuropathy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026