Efficacy and Safety Study of Intra-articular Multiple Doses of Icatibant in Patients With Painful Knee Osteoarthritis

Completed · Phase 2

Conditions studied: Joint Disease

In brief

The primary objective is to compare the overall treatment effect on pain relief between icatibant and placebo. The secondary objectives are to assess the efficacy of icatibant in term of onset, extent and duration of pain relief relative to triamcinolone, to evaluate the safety of icatibant, to evaluate overall conditions of daily life after treatment with icatibant, to assess systemic exposure of icatibant following intra-articular injection.

Key facts

Study ID

NCT00303056

Run by

Sanofi

People needed

590

Starts

2006-02-01

Expected to finish

2007-07-01

Last updated by the study team

2012-02-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female subjects with painful osteoarthritis of the knee.

You may not qualify if…

• Subjects presenting with diagnosis of OA < 3 months and an OA grading < K\&L grade II, with any condition with impact on on the target indication, any test-compound-related condition, any study-related condition (all those conditions detailled in the CSP).

Where it is running

• Administrative Office — Bridgewater, New Jersey, United States
• Administrative Office — Vienna, Austria
• Administrative Office — Prague, Czechia
• Administrative Office — Berlin, Germany
• Administrative Office — Warsaw, Poland

Full record on ClinicalTrials.gov

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