Dose-effect of SSR180575 in Diabetic Neuropathy

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00502515
First received: July 16, 2007
Last updated: January 19, 2010
Last verified: January 2010
  Purpose

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 Intervention Phase
Diabetic Neuropathies
Drug: SSR180575
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Rate of epidermal nerve fiber regeneration [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Efficacy: change between baseline and 24 weeks of peripheral neuropathy assessed with nerve conduction studies, clinical evaluation, Total Neuropathy Score [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Safety: physical examination, clinical laboratories, adverse event reporting [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 309
Study Start Date: July 2007
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
first dose
Drug: SSR180575
Oral, once daily dosing
Experimental: 2
second dose
Drug: SSR180575
Oral, once daily dosing
Placebo Comparator: 3 Drug: Placebo
Oral, once daily dosing

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00502515

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

No publications provided

Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00502515     History of Changes
Other Study ID Numbers: PDY5807
Study First Received: July 16, 2007
Last Updated: January 19, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
Diabetes
Neuropathy

Additional relevant MeSH terms:
Diabetic Neuropathies
Peripheral Nervous System Diseases
Demyelinating Diseases
Polyneuropathies
Nerve Compression Syndromes
Neurologic Manifestations
Neurotoxicity Syndromes
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Signs and Symptoms
Poisoning
Substance-Related Disorders

ClinicalTrials.gov processed this record on July 20, 2014