drugset / Trial / NCT01463488

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

NCT01463488 ↗

Phase 1 Completed 24 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
2011-11
Primary completion
2012-08
Completion
2012-08

Drugs

EvaluationDrugModalityDoseRoute
Subject SAR113945 Unknown — Other

Indications