Dose-effect of SSR180575 in Diabetic Neuropathy

Diabetic Neuropathies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00502515
• Other study ID #: PDY5807
• Status: Completed
• Phase: Phase 2
• First received: July 16, 2007
• Last updated: August 4, 2017
• Start date: July 2007
• Est. completion date: February 2009

Study information

• Verified date: August 2017
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 309
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Peripheral Nervous System Diseases

Intervention

Drug:
• SSR180575
Oral, once daily dosing
• Placebo
Oral, once daily dosing

Locations

Country	Name	City	State
United States	Sanofi-Aventis Administrative Office	Bridgewater	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of epidermal nerve fiber regeneration		24 weeks
Secondary	Efficacy: change between baseline and 24 weeks of peripheral neuropathy assessed with nerve conduction studies, clinical evaluation, Total Neuropathy Score		24 weeks
Secondary	Safety: physical examination, clinical laboratories, adverse event reporting		24 weeks