Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
309 participants
INTERVENTIONAL
2007-07-31
2009-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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25 mg SSR180575
orally once daily for 24 weeks
SSR180575
Oral, once daily dosing
100 mg SSR180575
orally once daily for 24 weeks
SSR180575
Oral, once daily dosing
Placebo
orally once daily for 24 weeks
Placebo
Oral, once daily dosing
Interventions
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SSR180575
Oral, once daily dosing
Placebo
Oral, once daily dosing
Eligibility Criteria
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Inclusion Criteria
* Diabetic neuropathy treated or untreated
Exclusion Criteria
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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ICD CSD
Role: STUDY_DIRECTOR
Sanofi
Locations
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Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States
Countries
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Other Identifiers
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PDY5807
Identifier Type: -
Identifier Source: org_study_id
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