Dose-effect of SSR180575 in Diabetic Neuropathy

• Sponsor: Sanofi (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00502515
• Collaborator: (none)
• Enrollment: 309
• Location: 1
• Arms: 3
• Duration (Months): 19.1
• Patients Per Site Per Month: 16.2

Study Details

Study Description

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 Design

• Study Type: Interventional
• 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: Jul 1, 2007
• Actual Primary Completion Date: Feb 1, 2009
• Actual Study Completion Date: Feb 1, 2009

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Rate of epidermal nerve fiber regeneration [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 [24 weeks]

2. Safety: physical examination, clinical laboratories, adverse event reporting [24 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sanofi-Aventis Administrative Office	Bridgewater	New Jersey	United States	08807

Sponsors and Collaborators

• Sanofi

Investigators

• Study Director: ICD CSD, Sanofi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sanofi
• ClinicalTrials.gov Identifier: NCT00502515
• Other Study ID Numbers: PDY5807
• First Posted: Jul 17, 2007
• Last Update Posted: Aug 8, 2017
• Last Verified: Aug 1, 2017

• Keywords provided by Sanofi: Diabetes; Neuropathy
• Additional relevant MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies

Study Results

No Results Posted as of Aug 8, 2017