Dose-effect of SSR180575 in Diabetic Neuropathy

Sanofi309 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

309

Conditions

Diabetic Neuropathies

Interventions

SSR180575DRUG

Oral, once daily dosing

PlaceboDRUG

Oral, once daily dosing

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Sanofi-Aventis Administrative Office

Bridgewater, New Jersey, United States

Outcomes

Primary Outcomes

Rate of epidermal nerve fiber regeneration

Time frame: 24 weeks

Secondary Outcomes

Efficacy: change between baseline and 24 weeks of peripheral neuropathy assessed with nerve conduction studies, clinical evaluation, Total Neuropathy Score

Time frame: 24 weeks

Safety: physical examination, clinical laboratories, adverse event reporting

Time frame: 24 weeks

Data from ClinicalTrials.gov

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