Dose-Effect of SSR180575 in Diabetic Neuropathy - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00502515

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
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:

MedlinePlus related topics: Diabetes Diabetic Nerve Problems Peripheral Nerve Disorders

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

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 ]

Estimated Enrollment:	270
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
1: Experimental first dose	Drug: SSR180575 Oral, once daily dosing
2: Experimental second dose	Drug: SSR180575 Oral, once daily dosing
3: Placebo Comparator	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

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-Aventis

Investigators

Study Director:

ICD CSD

Sanofi-Aventis

More Information

No publications provided

Responsible Party:	sanofi-aventis ( ICD Study Director )
Study ID Numbers:	PDY5807
Study First Received:	July 16, 2007
Last Updated:	March 16, 2009
ClinicalTrials.gov Identifier:	NCT00502515 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sanofi-Aventis:

Diabetes
Neuropathy

Study placed in the following topic categories:

Neuromuscular Diseases
Diabetic Neuropathies
Peripheral Nervous System Diseases
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Diabetes Complications

Additional relevant MeSH terms:

Neuromuscular Diseases
Diabetic Neuropathies
Peripheral Nervous System Diseases
Nervous System Diseases

Diabetes Mellitus
Endocrine System Diseases
Diabetes Complications

ClinicalTrials.gov processed this record on September 11, 2009