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MK0663, etoricoxib

Phase 3

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials4
Total Enrollment7,548

FDA Designations

No designations recorded

Clinical trial landscape

MK0663, etoricoxib · 6 trials · 3 indications

Phase 3 6
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
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
PHASE3COMPLETED
A Study of MK0663 and an Approved Drug in the Treatment of Osteoarthritis (0663-076)(COMPLETED)
OsteoarthritisUnlock trial analytics
PHASE3COMPLETED
A Study of MK0663 and an Approved Drug in the Treatment of Osteoarthritis (0663-077)(COMPLETED)
OsteoarthritisUnlock trial analytics
PHASE3COMPLETED
An Investigational Drug in Patients With Osteoarthritis (0663-073)
OsteoarthritisUnlock trial analytics
PHASE3COMPLETED
Investigational Drug Versus an Approved Drug in Patients With Rheumatoid Arthritis (0663-072)
Rheumatoid ArthritisUnlock trial analytics
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,OsteoarthritisUnlock trial analytics
PHASE3COMPLETED
Investigational Drug Versus an Approved Drug in Patients With Osteoarthritis (0663-061)(COMPLETED)
OsteoarthritisUnlock trial analytics

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
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.

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 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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Frequently asked questions about MK0663, etoricoxib

What is MK0663 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 that targets the COX-2 enzyme. By inhibiting COX-2, it is designed to reduce inflammation and pain associated with conditions like rheumatoid arthritis and osteoarthritis. This mechanism is the basis for its investigational use in these musculoskeletal disorders.

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 symbol OGN. The drug is currently in Phase 3 clinical trials for the treatment of rheumatoid arthritis and osteoarthritis.

What phase is MK0663 in?

MK0663, also known as etoricoxib, is in Phase 3 clinical development. It is an investigational drug being studied for rheumatoid arthritis and osteoarthritis, and it is not yet approved by regulatory authorities. Organon & Co. (NYSE: OGN) is the developer of this small molecule therapy.

What clinical trials is MK0663 in?

MK0663, also known as etoricoxib, has completed four Phase 3 clinical trials for osteoarthritis. These include NCT00092703 with 6,000 patients, NCT00092755 with 548 patients, and NCT00092768 and NCT00092781, each with 500 patients. All trials were completed and involved adult patients aged 40 or 50 years and older.

Is MK0663 the same as etoricoxib?

Yes, MK0663 is the same as etoricoxib. The drug is known by both names, with MK0663 being the investigational code and etoricoxib the generic name. It is being developed by Organon & Co. (NYSE: OGN) for the treatment of rheumatoid arthritis and osteoarthritis.