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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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