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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00502515 |
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 |
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 |
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1: Experimental
first dose
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Drug: SSR180575
Oral, once daily dosing
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2: Experimental
second dose
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Drug: SSR180575
Oral, once daily dosing
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3: Placebo Comparator |
Drug: Placebo
Oral, once daily dosing
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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 |
Diabetes Neuropathy |
Neuromuscular Diseases Diabetic Neuropathies Peripheral Nervous System Diseases Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Diabetes Complications |
Neuromuscular Diseases Diabetic Neuropathies Peripheral Nervous System Diseases Nervous System Diseases |
Diabetes Mellitus Endocrine System Diseases Diabetes Complications |