This trial is completed!
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You can access this
clinical trial
if you have
Knee Osteoarthritis
and you are
over 40
years old
Phase
2
This is a second phase trial assessing
efficacy and side effects of the new treatment.
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The purpose

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.

Provided treatments

  • Drug: SAR113945
  • Drug: placebo
Tris trial is registered with FDA with number: NCT01598415. The sponsor of the trial is Sanofi and it is looking for 130 volunteers for the current phase.
Official trial title:
A Two Part Protocol to Assess, Using Double Blind Placebo Control, the Safety, Tolerability, and Pharmacokinetics of Ascending Single Doses of a New Intra-articular Administration Formulation of SAR113945 (IKK Inhibitor) Followed by Assessment of Efficacy, Safety, Tolerability and Pharmacokinetics of a Single Dose in Patients With Knee Osteoarthritis.