Safety of Single Doses of SAR113945 and Efficacy and Safety of a New Formulation Given Into the Knee in Osteoarthritis Patients / Part I
- Registration Number
- NCT01463488
- 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
- 24
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SAR113945 - Dose 3 SAR113945 - Placebo placebo - SAR113945 - Dose 1 SAR113945 - SAR113945 - Dose 2 SAR113945 -
- Primary Outcome Measures
Name Time Method Pain, Stiffness and Physical Function sub-scales from the WOMAC Index 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
- Secondary Outcome Measures
Name Time Method Pharmacokinetics (Cmax) during 24 weeks Pharmacokinetics (AUC) during 24 weeks Pharmacokinetics (t1/2) during 24 weeks synovial fluid levels during 24 weeks
Trial Locations
- Locations (1)
Investigational Site Number 276001
🇩🇪Berlin, Germany