Dose-effect of SSR180575 in Diabetic Neuropathy

Phase 2

Completed

• Conditions: Diabetic Neuropathies
• Interventions: Drug: SSR180575; Drug: Placebo

• Registration Number: NCT00502515
• Lead Sponsor: Sanofi

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2007-07-16
• Study First Submitted QC: 2007-07-16
• Study First Posted: 2007-07-17
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Status Verified: 2017-08
• Disposition First Submitted: 2017-08-04
• Disposition First Submitted QC: 2017-08-04
• Last Update Submitted: 2017-08-04
• Disposition First Posted: 2017-08-08
• Last Update Posted: 2017-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 309

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
25 mg SSR180575	SSR180575	orally once daily for 24 weeks
100 mg SSR180575	SSR180575	orally once daily for 24 weeks
Placebo	Placebo	orally once daily for 24 weeks

Primary Outcome Measures

Name	Time	Method
Rate of epidermal nerve fiber regeneration	24 weeks

Secondary Outcome Measures

Name	Time	Method
Efficacy: change between baseline and 24 weeks of peripheral neuropathy assessed with nerve conduction studies, clinical evaluation, Total Neuropathy Score	24 weeks
Safety: physical examination, clinical laboratories, adverse event reporting	24 weeks

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇺🇸 Bridgewater, New Jersey, United States