Back to resultsDose-effect of SSR180575 in Diabetic Neuropathy
Primary Purpose
Diabetic Neuropathies
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
SSR180575
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Neuropathies focused on measuring Diabetes, Neuropathy
Eligibility 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.
Sites / Locations
- Sanofi-Aventis Administrative Office
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
25 mg SSR180575
100 mg SSR180575
Placebo
Arm Description
orally once daily for 24 weeks
orally once daily for 24 weeks
orally once daily for 24 weeks
Outcomes
Primary Outcome Measures
Rate of epidermal nerve fiber regeneration
Secondary Outcome Measures
Efficacy: change between baseline and 24 weeks of peripheral neuropathy assessed with nerve conduction studies, clinical evaluation, Total Neuropathy Score
Safety: physical examination, clinical laboratories, adverse event reporting
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00502515
Brief Title
Dose-effect of SSR180575 in Diabetic Neuropathy
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 Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Neuropathies
Keywords
Diabetes, Neuropathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
309 (Actual)
8. Arms, Groups, and Interventions
Arm Title
25 mg SSR180575
Arm Type
Experimental
Arm Description
orally once daily for 24 weeks
Arm Title
100 mg SSR180575
Arm Type
Experimental
Arm Description
orally once daily for 24 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
orally once daily for 24 weeks
Intervention Type
Drug
Intervention Name(s)
SSR180575
Intervention Description
Oral, once daily dosing
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral, once daily dosing
Primary Outcome Measure Information:
Title
Rate of epidermal nerve fiber regeneration
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Efficacy: change between baseline and 24 weeks of peripheral neuropathy assessed with nerve conduction studies, clinical evaluation, Total Neuropathy Score
Time Frame
24 weeks
Title
Safety: physical examination, clinical laboratories, adverse event reporting
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ICD CSD
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis Administrative Office
City
Bridgewater
State/Province
New Jersey
ZIP/Postal Code
08807
Country
United States
12. IPD Sharing Statement
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Dose-effect of SSR180575 in Diabetic Neuropathy
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