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.

Trial Profile

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.

Completed
Phase of Trial: Phase I/II

Latest Information Update: 27 Nov 2014

At a glance

  • Drugs SAR 113945 (Primary)
  • Indications Osteoarthritis
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors Sanofi
  • Most Recent Events

    • 19 Oct 2012 Planned number of patients (154) added as reported by European Clinical Trials Database.
    • 19 Oct 2012 New source identified and integrated (European Clinical Trials Database; EudraCT2011-003232-31)
    • 22 Aug 2012 Actual end date (Aug 2012) added as reported by ClinicalTrials.gov.
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