Dose-effect of SSR180575 in Diabetic Neuropathy

• Status: Completed
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this sudy is to assess the effect of two doses of SSR180575 on the rate of regeneration of epidermal nerve fibers following denervation of the epidermal layer with capsaicin in patients with diabetes mellitus and mild peripheral neuropathy. Secondary objectives are to explore the efficacy of SSR180575 on clinical assessment, nerve function measures and to assess the tolerability and safety of SSR180575. The treatment period is 6 months.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi

Criteria

Inclusion Criteria:

• Patients diagnosed with Diabetes Mellitus, type I or II, treated or untreated

• Diabetic neuropathy treated or untreated

Exclusion Criteria:

• Patients with unstable glycemic control

• Patients who have been hospitalized for a diabetes complication in the 3 months prior to randomization

• Patients with peripheral neuropathy attributable to any cause other than diabetes

• Non-measurable sural nerve sensory response on nerve conduction studies

• Amputation of any part of lower extremity

• Patients with a history of myocardial infarction or known coronary artery disease

• Grade III or IV heart failure on New York Heart Association criteria

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.