Dose-effect of SSR180575 in Diabetic Neuropathy
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
1 other identifier
interventional
309
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2007
CompletedFirst Submitted
Initial submission to the registry
July 16, 2007
CompletedFirst Posted
Study publicly available on registry
July 17, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2009
CompletedAugust 8, 2017
August 1, 2017
1.6 years
July 16, 2007
August 4, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of epidermal nerve fiber regeneration
24 weeks
Secondary Outcomes (2)
Efficacy: change between baseline and 24 weeks of peripheral neuropathy assessed with nerve conduction studies, clinical evaluation, Total Neuropathy Score
24 weeks
Safety: physical examination, clinical laboratories, adverse event reporting
24 weeks
Study Arms (3)
25 mg SSR180575
EXPERIMENTALorally once daily for 24 weeks
100 mg SSR180575
EXPERIMENTALorally once daily for 24 weeks
Placebo
PLACEBO COMPARATORorally once daily for 24 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Patients diagnosed with Diabetes Mellitus, type I or II, treated or untreated
- Diabetic neuropathy treated or untreated
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
Study Sites (1)
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, 08807, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ICD CSD
Sanofi
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 16, 2007
First Posted
July 17, 2007
Study Start
July 1, 2007
Primary Completion
February 1, 2009
Study Completion
February 1, 2009
Last Updated
August 8, 2017
Record last verified: 2017-08