NCT00502515

Dose-effect of SSR180575 in Diabetic Neuropathy

A Multi-center, Randomized, Double-blind, Placebo Controlled Study of the Effect of SSR180575 at Two Doses for 24 Weeks Treatment on the Rate of Regeneration of Epidermal Nerve Fibers in Patients With Mild Diabetic Peripheral Neuropathy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 309 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetic Neuropathies

Interventions

Type	Name	Description
DRUG	SSR180575	Oral, once daily dosing
DRUG	Placebo	Oral, once daily dosing

Timeline

• Start date: 2007-07-01
• Primary completion: 2009-02-01
• Completion: 2009-02-01
• First posted: 2007-07-17
• Last updated: 2017-08-08

Locations

1 site across 1 country: United States