Status:

COMPLETED

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

Lead Sponsor:

Sanofi

Conditions:

Joint Disease

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

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...

Detailed Description

This is a multinational, randomized, placebo-controlled study to be conducted in Europe and the US. Study medication will be administered by intra-articular injection 3 times in weekly intervals, bein...

Eligibility Criteria

Inclusion

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

Exclusion

  • 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).

Key Trial Info

Start Date :

February 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 1 2007

Estimated Enrollment :

590 Patients enrolled

Trial Details

Trial ID

NCT00303056

Start Date

February 1 2006

End Date

July 1 2007

Last Update

February 17 2012

Active Locations (5)

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Page 1 of 2 (5 locations)

1

Administrative Office

Bridgewater, New Jersey, United States, 08807

2

Administrative Office

Vienna, Austria, DCA 1220

3

Administrative Office

Prague, Czechia, 160 00

4

Administrative Office

Berlin, Germany, D-10785