Completed

Mexiletine for Painful Diabetic Neuropathy Treatment

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What is being tested

mexiletine

Drug
Who is being recruted

Diabetes Mellitus+15

+ Endocrine System Diseases

+ Nervous System Diseases

From 21 to 60 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: March 1993
See protocol details

Summary

Principal SponsorNational Center for Research Resources (NCRR)
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 1993

Actual date on which the first participant was enrolled.

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.

NCT00004647
Principal SponsorNational Center for Research Resources (NCRR)
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 21 to 60 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Diabetes MellitusEndocrine System DiseasesNervous System DiseasesNeuromuscular DiseasesPathologic ProcessesPeripheral Nervous System DiseasesSensation DisordersSigns and SymptomsPathological Conditions, Signs and SymptomsSomatosensory DisordersDisease AttributesDiabetes ComplicationsMental DisordersDiabetic NeuropathiesNeurologic ManifestationsPainParesthesiaRare Diseases

Criteria

Patients with painful diabetic neuropathy

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has no location dataSave this study to your profile to know when the location data is available.
CompletedNo study centers