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



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

For Condition: Pain,Paresthesia,Diabetic Neuropathies
Status: Completed
Sponsor(s): National Center for Research Resources (NCRR) , University of Tennessee
Synopsis: OBJECTIVES: I. Assess the efficacy and toxicity of mexiletine in the management of paresthesias and pain in patients with diabetic neuropathy.
Details: 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.
Eligibility:
Study Type:
  Interventional, Treatment, Randomized, Double-Blind
Minimum Age/Maximum Age: 21 Years/60 Years
Genders: Both
Protocol Entry Criteria: Patients with painful diabetic neuropathy
Total Enrollment: 40

Location and Contact Information:

Overall Study Official:
TulioBertorini,  Study Chair,  University of Tennessee


Additional Information:
Study ID Numbers:
  199/11702;  UTENN-4686
Study Start Date: March 1993
Record last reviewed: March 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004647

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2. Dextromethorphan Versus Placebo for Neuropathic Pain

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

4. Treatment of Peripheral Neuropathy in Patients with Diabetes.

5. LY333531 Treatment for Symptomatic Peripheral Neuropathy in Patients with Diabetes.

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