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MK0663, etoricoxib

Phase 3

Osteoarthritis | Small molecule | Musculoskeletal |Organon & Co.|Last Updated: Aug 15, 2024

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 Trials4
Total Enrollment7,548
FDA Designations
No designations recorded
Clinical Trials (4)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00092768A Study of MK0663 and an Approved Drug in the Treatment of Osteoarthritis (0663-076)(COMPLETED)PHASE3 COMPLETED 500 — — Mar 1, 2004Feb 1, 2005Aug 15, 2024 - —
NCT00092781A Study of MK0663 and an Approved Drug in the Treatment of Osteoarthritis (0663-077)(COMPLETED)PHASE3 COMPLETED 500 — — Mar 1, 2004Feb 1, 2005Aug 15, 2024 - —
NCT00092755An Investigational Drug in Patients With Osteoarthritis (0663-073)PHASE3 COMPLETED 548 — — Apr 9, 2003Nov 13, 2003Aug 15, 2024 - —
NCT00092703Investigational Drug Versus an Approved Drug in Patients With Osteoarthritis (0663-061)(COMPLETED)PHASE3 COMPLETED 6,000 — — Jun 27, 2002Nov 1, 2003Aug 15, 2024 - —
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Study Endpoints
Primary Endpoints
Osteoarthritis of the knee & hip as assessed by WOMAC VA 3.0 pain and physical function subscales, Patient/Investigator assessments of disease and response to therapy over 12 weeks of treatment.
WOMAC VA 3.0 pain subscale, WOMAC VA 3.0 physical function subscale, and Patient Global Assessment of Disease Status Scale. Efficacy data collected at Weeks 2, 4, 8, and 12.
Discontinuations due to clinical and laboratory gastrointestinal adverse experiences during a 1 year treatment period.
Secondary Endpoints
Maintenance of clinical efficacy as assessed by WOMAC subscales and Patient assessments over a 26-wks of treatment. Safety / tolerability over a 12-wk and 6-mo treatment period.
Maintenance of clinical efficacy as assessed by WOMAC subscales and Patient assessments over a 26-wks of treatment. To evaluate the safety / tolerability over a 12-wk and 6-mo treatment period.
Patient Global Assessment of Response to Therapy, Investigator Global Assessment of Disease Status, Womac VA 3.0: Stiffness, Overall Average Score and Overall Subscale Average. Clinical efficacy data collected at Weeks 2, 4, 8, and 12.
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
MK0663, etoricoxibDRUG -
Comparator: celecoxibDRUG -
Comparators: ibuprofen and placeboDRUG -
Comparator: Diclofenac sodiumDRUG -
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Eligibility Criteria
Age Range40 Years — N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Osteoarthritis of the knee or hip which requires treatment with a medication to obtain pain relief Exclusion Criteria: * Any known allergy to the study drugs

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Competitive Landscape -Osteoarthritis 115 trials
CompanyTickerTrialsLead PhaseDrugs
Eli Lilly and CompanyLLY3PHASE3Eloralintide, Orforglipron, LY3016859 ISA, LY3556050 ISA, LY3526318 ISA
Pacira Biosciences, Inc.PCRX4PHASE3ZILRETTA, Enekinragene Inzadenovec, FX201
Novo Nordisk A/S Sponsored ADR Class BNVO1PHASE3NNC0487-0111
Bioventus, Inc. Class ABVS1PHASE2PTP-001
Enlivex Ltd.ENLV2PHASE1Allocetra, Allocetra-OTS
Smith & Nephew plc Sponsored ADRSNN10 — Undisclosed
Stryker CorporationSYK11NAUndisclosed
Zimmer Biomet Holdings, Inc.ZBH57NAUndisclosed
Merit Medical Systems, Inc.MMSI1NACorticosteroid
Johnson & JohnsonJNJ1NAUndisclosed
Abbott LaboratoriesABT1NAUndisclosed
Enovis CorporationENOV1NAUndisclosed
Teleflex IncorporatedTFX1 — Undisclosed
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