drugset / Trial / NCT01598415

Safety of Single Doses of SAR113945 and Efficacy and Safety of a New Formulation Given Into the Knee in Osteoarthritis Patients / Part II

NCT01598415 ↗

Phase 2 Completed 130 enrolled Sanofi
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2012-04
Primary completion
2013-02
Completion
2013-02

Drugs

EvaluationDrugModalityDoseRoute
Subject SAR113945 Unknown — Other

Indications