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valdecoxib

Phase 3

Osteoarthritis | Small molecule | Musculoskeletal |Pfizer, Inc.|Last Updated: Dec 5, 2018

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-BlindACTIVE_CONTROLLED
Total Trials2
Total Enrollment395
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00652808Double-Blind, Double Dummy, Randomized Comparison Study to Evaluate the Efficacy and Safety of Valdecoxib 10 mg Once Daily and Naproxen 500 mg Twice Daily in Treating the Signs and Symptoms of Osteoarthritis of the KneePHASE3 COMPLETED 265May 1, 2004Sep 1, 2004Apr 10, 20088 South Korea
NCT00648258A Double-Blind, Double Dummy, Randomized Comparison Study Of The Efficacy And Safety Of Valdecoxib 10mg Once Daily And Naproxen 500mg Twice Daily In Treating The Signs And Symptoms Of Osteoarthritis Of The Knee Or Hip In TaiwanPHASE3 COMPLETED 130Jul 1, 2003Apr 1, 2004Dec 5, 20184 Taiwan
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Study Endpoints
Primary Endpoints
Patient's Assessment of Arthritis Pain using a Visual Analogue Scale (OA-Pain VAS)
Week 6
Patient's Assessment of Arthritis Pain (Osteoarthritis-Pain VAS)
Week 6
Secondary Endpoints
WOMAC OA Physical Function
Week 2 and Week 6
WOMAC OA Stiffness Index
Week 2 and Week 6
Patient's Assessment of Arthritis Pain using a Visual Analogue Scale (OA-Pain VAS)
Week 2
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm 1ACTIVE_COMPARATOR -
Arm 2ACTIVE_COMPARATOR -
Interventions
NameTypeDescription
valdecoxibDRUGvaldecoxib 10 mg tablet by mouth once daily for 6 weeks
naproxenDRUGnaproxen 500 mg capsule by mouth twice daily for 6 weeks
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: * Korean outpatients with symptomatic radiologic evidence of OA of the knee (diagnosed according to the modified American College Rheumatology criteria) * Patient's Assessment of Arthritis Pain measurement of at least 40 mm on VAS * Patients had not received any NSAIDs or analge...

Countries:South KoreaTaiwan
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