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Celebrex

Phase 3

Osteoarthritis,Knee | Small molecule | Musculoskeletal |Pfizer, Inc.|Last Updated: Jun 10, 2008

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment200
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00137410Celebrex Short Versus Long Therapy In Osteoarthritis Of The KneePHASE3 COMPLETED 200Nov 1, 2002Mar 1, 2006Jun 10, 200816 Italy
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Study Endpoints
Primary Endpoints
Time elapsing between the last drug administration and a new flare, if any, occurring within a 12 months FU and proportion pts with a new flare
Secondary Endpoints
Flare intensity WOMAC OA index Psycho-affective Index Pt's assessment of OA pain (VAS) Pt's & Physician's global assessment disease severity Incidence of total AEs Incidence of GI AEs: Incidence of changes in: hematology, renal function, liver function
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
CelebrexDRUG -
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Eligibility Criteria
Age Range50 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites16

Inclusion Criteria: * diagnosis of OA of the knee according to the ACR Classification Criteria for osteoarthritis; * patients in flare Exclusion Criteria: * any concomitant inflammatory rheumatic condition which may interfere with the assessment of OA * clinical or radiological evidence of chondr...

Countries:Italy
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