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Completed

NCT Number: NCT00502515

Dose-effect of SSR180575 in Diabetic Neuropathy

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.

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Key information

Conditions

Diabetic Neuropathies Diabetes Complications Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nervous System Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Peripheral Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sanofi-Aventis Administrative Office

Bridgewater, New Jersey, 08807, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SSR180575

Drug

Oral, once daily dosing

Placebo

Drug

Oral, once daily dosing

Primary outcomes

  1. Rate of epidermal nerve fiber regeneration

    Time frame: 24 weeks

Secondary outcomes

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

    Time frame: 24 weeks

  2. Safety: physical examination, clinical laboratories, adverse event reporting

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Jul 17, 2007
Registry last updated
Aug 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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