Dose-effect of SSR180575 in Diabetic Neuropathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00502515
Recruitment Status : Completed
First Posted : July 17, 2007
Last Update Posted : August 8, 2017
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Diabetic Neuropathies Drug: SSR180575 Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 309 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : July 2007
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 25 mg SSR180575
orally once daily for 24 weeks
Drug: SSR180575
Oral, once daily dosing
Experimental: 100 mg SSR180575
orally once daily for 24 weeks
Drug: SSR180575
Oral, once daily dosing
Placebo Comparator: Placebo
orally once daily for 24 weeks
Drug: Placebo
Oral, once daily dosing

Primary Outcome Measures :
  1. Rate of epidermal nerve fiber regeneration [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00502515

United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
Sponsors and Collaborators
Study Director: ICD CSD Sanofi

Responsible Party: Sanofi Identifier: NCT00502515     History of Changes
Other Study ID Numbers: PDY5807
First Posted: July 17, 2007    Key Record Dates
Last Update Posted: August 8, 2017
Last Verified: August 2017

Keywords provided by Sanofi:

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Diabetic Neuropathies
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases