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MK0966, rofecoxib

Phase 3

Osteoarthritis | Small molecule | Musculoskeletal |Merck & Company, Inc.|Last Updated: May 9, 2017

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 Trials2
Total Enrollment808
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00092352A Study of Two Approved Drugs in Patients With Osteoarthritis (0966-219)PHASE3 COMPLETED 395Apr 29, 2003Dec 1, 2003May 9, 2017 -
NCT00092365A Study of Two Approved Drugs in Patients With Osteoarthritis (0966-220)(COMPLETED)PHASE3 COMPLETED 413Apr 1, 2003Nov 1, 2003May 9, 2017 -
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Study Endpoints
Primary Endpoints
Osteoarthritis (OA) of the knee as measured by Patient Global Assessment of Response to Therapy (PGART) and WOMAC VA 3.0 over 6 weeks of treatment.
Secondary Endpoints
OA of the knee as measured by PGART over 6 wks of treatment.
WOMAC Question #1 over 6 wks of treatment.
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
MK0966, rofecoxibDRUG -
Comparator: celecoxib, placeboDRUG -
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Eligibility Criteria
Age Range40 Years — N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Osteoarthritis of the knee which requires treatment with medication for pain relief Exclusion Criteria: * Any known allergy to the study drug

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