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Sponsors and Collaborators: |
National Center for Research Resources (NCRR) University of Tennessee |
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Information provided by: | Office of Rare Diseases (ORD) |
ClinicalTrials.gov Identifier: | NCT00004647 |
OBJECTIVES:
I. Assess the efficacy and toxicity of mexiletine in the management of paresthesias and pain in patients with diabetic neuropathy.
Condition | Intervention | Phase |
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Pain Diabetic Neuropathies Paresthesia |
Drug: mexiletine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind |
Estimated Enrollment: | 40 |
Study Start Date: | March 1993 |
Estimated Study Completion Date: | February 1999 |
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.
Ages Eligible for Study: | 21 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Patients with painful diabetic neuropathy
Study ID Numbers: | 199/11702, UTENN-4686 |
Study First Received: | February 24, 2000 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00004647 History of Changes |
Health Authority: | United States: Federal Government |
diabetic neuropathy disease-related problem/condition neurologic and psychiatric disorders pain rare disease |
Sensation Disorders Diabetic Neuropathies Rare Diseases Diabetes Mellitus Endocrine System Diseases Mexiletine Pain Cardiovascular Agents Signs and Symptoms |
Somatosensory Disorders Neuromuscular Diseases Mental Disorders Paresthesia Peripheral Nervous System Diseases Neurologic Manifestations Anti-Arrhythmia Agents Endocrinopathy Diabetes Complications |
Sensation Disorders Diabetic Neuropathies Nervous System Diseases Diabetes Mellitus Endocrine System Diseases Mexiletine Cardiovascular Agents Pharmacologic Actions Somatosensory Disorders |
Signs and Symptoms Neuromuscular Diseases Therapeutic Uses Paresthesia Peripheral Nervous System Diseases Neurologic Manifestations Anti-Arrhythmia Agents Diabetes Complications |