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MK0663, etoricoxib

Phase 3

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials11
Total Enrollment37,987

FDA Designations

No designations recorded

MK0663, etoricoxib clinical trials

MK0663, etoricoxib · 11 trials · 4 indications

Phase 3 10Phase 2 1
NCT00092768A Study of MK0663 and an Approved Drug in the Treatment of Osteoarthritis (0663-076)(COMPLETED)Osteoarthritis
COMPLETED500 Analytics
NCT00092781A Study of MK0663 and an Approved Drug in the Treatment of Osteoarthritis (0663-077)(COMPLETED)Osteoarthritis
COMPLETED500 Analytics
NCT00092755An Investigational Drug in Patients With Osteoarthritis (0663-073)Osteoarthritis
COMPLETED548 Analytics
NCT00269191A Study to Assess the Safety and Efficacy of an Investigational Drug in Patients With Osteoarthritis (0663-071)(COMPLETED)Osteoarthritis
COMPLETED528 Analytics
NCT00092742Investigational Drug Versus an Approved Drug in Patients With Rheumatoid Arthritis (0663-072)Rheumatoid Arthritis
COMPLETED4,086 Analytics
NCT00250445A Study to Evaluate the Safety of an Investigational Drug (Etoricoxib) in Patients With Osteoarthritis (OA) or Rheumatoid Arthritis (RA)(0663-066)Rheumatoid Arthritis,Osteoarthritis
COMPLETED23,498 Analytics
NCT00092703Investigational Drug Versus an Approved Drug in Patients With Osteoarthritis (0663-061)(COMPLETED)Osteoarthritis
COMPLETED6,000 Analytics
NCT00542087Etoricoxib vs. Diclofenac in OA (0663-805)(COMPLETED)Osteoarthritis
COMPLETED516 Analytics
NCT00393211Effect of Etoricoxib to Treat Chronic Low Back Pain (0663-042)Recurrent Low Back Pain
COMPLETED319 Analytics
NCT00393354Effect of Etoricoxib to Treat Chronic Low Back Pain (0663-041)Recurrent Low Back Pain
COMPLETED325 Analytics
PHASE3COMPLETED
A Study of MK0663 and an Approved Drug in the Treatment of Osteoarthritis (0663-076)(COMPLETED)
Osteoarthritis
NCT00092768500
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PHASE3COMPLETED
A Study of MK0663 and an Approved Drug in the Treatment of Osteoarthritis (0663-077)(COMPLETED)
Osteoarthritis
NCT00092781500
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PHASE3COMPLETED
An Investigational Drug in Patients With Osteoarthritis (0663-073)
Osteoarthritis
NCT00092755548
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PHASE3COMPLETED
A Study to Assess the Safety and Efficacy of an Investigational Drug in Patients With Osteoarthritis (0663-071)(COMPLETED)
Osteoarthritis
NCT00269191528
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PHASE3COMPLETED
Investigational Drug Versus an Approved Drug in Patients With Rheumatoid Arthritis (0663-072)
Rheumatoid Arthritis
NCT000927424,086
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PHASE3COMPLETED
A Study to Evaluate the Safety of an Investigational Drug (Etoricoxib) in Patients With Osteoarthritis (OA) or Rheumatoid Arthritis (RA)(0663-066)
Rheumatoid Arthritis,Osteoarthritis
NCT0025044523,498
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PHASE3COMPLETED
Investigational Drug Versus an Approved Drug in Patients With Osteoarthritis (0663-061)(COMPLETED)
Osteoarthritis
NCT000927036,000
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PHASE3COMPLETED
Etoricoxib vs. Diclofenac in OA (0663-805)(COMPLETED)
Osteoarthritis
NCT00542087516
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PHASE3COMPLETED
Effect of Etoricoxib to Treat Chronic Low Back Pain (0663-042)
Recurrent Low Back Pain
NCT00393211319
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PHASE3COMPLETED
Effect of Etoricoxib to Treat Chronic Low Back Pain (0663-041)
Recurrent Low Back Pain
NCT00393354325
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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.
Pain and physical function over 12-weeks as assessed by the WOMAC VA 3.0 pain subscale, WOMAC VA 3.0 physical function subscale, and Patient Global Assessment of Disease Status, as well as safety over 12-weeks as assessed by adverse experiences.
Discontinuations due to clinical and laboratory gastrointestinal adverse experiences
Incidence of Confirmed Thrombotic Cardiovascular Serious Adverse Experiences based on combined data from this trial and MK0663 Protocols 061 & 072 (GI Tolerability in OA Patients and GI Tolerability Study in RA Patients ), respectively.
Discontinuations due to clinical and laboratory gastrointestinal adverse experiences during a 1 year treatment period.
This study will assess the effectiveness of the study drug vs. a comparator to treat successfully OA-related joint pain (judged by WOMAC pain subscale).
Low back pain intensity scale (0-100 mm VAS) over 4 weeks compared to placebo
WOMAC Pain Subscale, Investigator Global Assessment of Disease Status, and Patient Global Assessment of Response to Therapy (not a primary endpoint in extension periods)

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 -
MK0663, etoricoxib / Duration of Treatment 12 WeeksDRUG -
Placebo or Ibuprofen / Duration of Treatment 12 WeeksDRUG -
Comparator: Diclofenac sodiumDRUG -
MK0663, etoricoxib / Duration of Treatment: 6 WeeksDRUG -
Comparator: diclofenac sodium / Duration of Treatment: 6 WeeksDRUG -
MK0663, Etoricoxib / Duration of Treatment : 12 WeeksDRUG -
Comparator : placebo (unspecified) /Duration of Treatment : 12 WeeksDRUG -
MK0663, etoricoxib / Duration of Treatment: Part I (6 weeks), Part II (8 weeks)DRUG -
Placebo;Diclofenac 50mg(tid)/Duration of Treatment: Part I (Placebo) 6 weeks;Part II (Diclofenac) 8 weeksDRUG -
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Eligibility Criteria

Age Range40 Years to 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 143 trials

Top 5 of 14 competitors

CompanyTickerTrialsLead PhaseDrugs
Eli Lilly and CompanyLLY4PHASE3Orforglipron, Eloralintide, LY3016859, LY3556050, LY3526318
Pacira Biosciences, Inc.PCRX4PHASE3ZILRETTA, Enekinragene Inzadenovec, FX201
Novo Nordisk A/S Sponsored ADR Class BNVO2PHASE3NNC0487-0111
Bioventus, Inc. Class ABVS1PHASE2PTP-001
Enlivex Ltd.ENLV2PHASE1Allocetra
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Frequently asked questions about MK0663, etoricoxib

What is MK0663 (etoricoxib) used for?

MK0663, also known as etoricoxib, is an investigational small molecule being studied for the treatment of rheumatoid arthritis and osteoarthritis. It is in Phase 3 clinical development for these musculoskeletal conditions. The drug is being developed by Organon & Co. (NYSE: OGN).

What does MK0663 target?

MK0663, or etoricoxib, is a small molecule being studied for rheumatoid arthritis and osteoarthritis. The specific molecular target has not been disclosed in the available clinical trial information. It is in Phase 3 development by Organon & Co. (NYSE: OGN).

Who makes MK0663?

MK0663, also known as etoricoxib, is being developed by Organon & Co., a pharmaceutical company traded on the New York Stock Exchange under the ticker OGN. The drug is currently in Phase 3 clinical trials for rheumatoid arthritis and osteoarthritis.

What phase is MK0663 in?

MK0663, or etoricoxib, is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied for the treatment of rheumatoid arthritis and osteoarthritis by Organon & Co. (NYSE: OGN).

What clinical trials is MK0663 in?

MK0663, or etoricoxib, has four completed Phase 3 clinical trials for osteoarthritis: NCT00092703 with 6,000 patients, NCT00092755 with 548 patients, NCT00092768 with 500 patients, and NCT00092781 with 500 patients. All trials are completed and were conducted by Organon & Co.

Is MK0663 the same as etoricoxib?

Yes, MK0663 is also known as etoricoxib. It is an investigational small molecule being developed by Organon & Co. (NYSE: OGN) for the treatment of rheumatoid arthritis and osteoarthritis. The drug is currently in Phase 3 clinical development.

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