drugset / Trial / NCT00502515

Dose-effect of SSR180575 in Diabetic Neuropathy

NCT00502515 ↗

Phase 2 Completed 309 enrolled Sanofi
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2007-07
Primary completion
2009-02
Completion
2009-02

Drugs

EvaluationDrugModalityDoseRoute
Subject SSR180575 Unknown 25 mg Oral
Subject SSR180575 Unknown 100 mg Oral

Indications