Safety of Single Doses of SAR113945 and Efficacy and Safety of a New Formulation Given Into the Knee in Osteoarthritis Patients / Part II
- Registration Number
- NCT01598415
- Lead Sponsor
- Sanofi
- Brief Summary
Study objectives:
* Part 1 TDU11685 To assess in patients with knee Osteoarthritis (OA), the safety, tolerability and pharmacokinetics (PK) of single intra-articular doses of SAR113945.
* Part 2 ACT12505 To assess in patients with knee OA, the efficacy, safety and tolerability of a single intra-articular dose of SAR113945.
- Detailed Description
- Screening will be performed within 28 days of dosing. Following the single dose of study medication, the study period for each patient will be 168 days.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 130
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo placebo - SAR113945 SAR113945 TDU11685 selected dose
- Primary Outcome Measures
Name Time Method Womac Pain Score (5 items) at 8 weeks
- Secondary Outcome Measures
Name Time Method Womac Pain Score (5 items) during 24 weeks Womac Total Score (24 items) during 24 weeks Womac Stiffness (2 items) during 24 weeks Womac Physical Function (17 items) during 24 weeks synovial fluid levels during 24 weeks Number of patients reporting Adverse Events of special interest: tolerability at the site of injection and in the knee + other events reported by the patient during 24 weeks
Trial Locations
- Locations (2)
Investigational Site Number 276001
🇩🇪Berlin, Germany
Investigational Site Number 276002
🇩🇪München, Germany