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MK0966, rofecoxib

Phase 3

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials2
Total Enrollment808

FDA Designations

No designations recorded

Clinical trial landscape

MK0966, rofecoxib · 8 trials · 3 indications

Phase 3 8
NCT00092378A Study of Two Approved Drugs in the Treatment of Post-Bunionectomy Surgery Pain (0966-234)(COMPLETED)Postoperative Pain
COMPLETED251 Analytics
NCT00092352A Study of Two Approved Drugs in Patients With Osteoarthritis (0966-219)Osteoarthritis
COMPLETED395 Analytics
NCT00092365A Study of Two Approved Drugs in Patients With Osteoarthritis (0966-220)(COMPLETED)Osteoarthritis
COMPLETED413 Analytics
NCT00092339A Study of Two Approved Drugs in the Treatment of Postoperative Dental Pain (0966-190)(COMPLETED)Postoperative Pain
COMPLETED125 Analytics
NCT00092313A Study of Two Approved Drugs in the Treatment of Postoperative Dental Pain (0966-182)Postoperative Pain
COMPLETED271 Analytics
NCT00092326A Study of Two Approved Drugs in the Treatment of Postoperative Dental Pain (0966-183)Postoperative Pain
COMPLETED269 Analytics
NCT00092300A Study of Two Approved Drugs in the Treatment of Postoperative Dental Pain (0966-181)(COMPLETED)Postoperative Pain
COMPLETED450 Analytics
NCT00390260Effect of Rofecoxib and a Narcotic Analgesic to Treat Pain Following Arthroscopic Surgery (0966-179)(COMPLETED)Pain, Postoperative Arthroscopy
COMPLETED420 Analytics
PHASE3COMPLETED
A Study of Two Approved Drugs in the Treatment of Post-Bunionectomy Surgery Pain (0966-234)(COMPLETED)
Postoperative PainUnlock trial analytics
PHASE3COMPLETED
A Study of Two Approved Drugs in Patients With Osteoarthritis (0966-219)
OsteoarthritisUnlock trial analytics
PHASE3COMPLETED
A Study of Two Approved Drugs in Patients With Osteoarthritis (0966-220)(COMPLETED)
OsteoarthritisUnlock trial analytics
PHASE3COMPLETED
A Study of Two Approved Drugs in the Treatment of Postoperative Dental Pain (0966-190)(COMPLETED)
Postoperative PainUnlock trial analytics
PHASE3COMPLETED
A Study of Two Approved Drugs in the Treatment of Postoperative Dental Pain (0966-182)
Postoperative PainUnlock trial analytics
PHASE3COMPLETED
A Study of Two Approved Drugs in the Treatment of Postoperative Dental Pain (0966-183)
Postoperative PainUnlock trial analytics
PHASE3COMPLETED
A Study of Two Approved Drugs in the Treatment of Postoperative Dental Pain (0966-181)(COMPLETED)
Postoperative PainUnlock trial analytics
PHASE3COMPLETED
Effect of Rofecoxib and a Narcotic Analgesic to Treat Pain Following Arthroscopic Surgery (0966-179)(COMPLETED)
Pain, Postoperative ArthroscopyUnlock trial analytics

Study Endpoints

Primary Endpoints

Overall analgesic effect over 8 hours
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.
Overall analgesic effect as measured by total pain relief over 12 hours.
Post-op dental pain over 6 hours as measured by pain intensity/relief scores, patient global assessment, and time to perceptible/meaningful pain relief.
Overall analgesic effect over 12 hours.
Total Pain Relief over 6 hours following a single oral dose compared to placebo.
6 hours

Secondary Endpoints

Time to onset of analgesic effect.
The use of supplemental analgesia on Days 2-3.
Peak analgesic effect on Day 1.
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
MK0966, rofecoxibDRUG -
Comparator: diclofenac sodium, placeboDRUG -
Comparator: celecoxib, placeboDRUG -
Comparator: valdecoxib, placeboDRUG -
Comparator: oxycodone and acetaminophenDRUG -
Comparator: oxycodone with acetaminophen, placeboDRUG -
Comparator: valdecoxibDRUG -
MK0966 / Duration of Treatment: 1 DaysDRUG -
Comparator: acetaminophen (+) hydrocodone bitartrate / Duration of Treatment: 1 DaysDRUG -
Comparator: placebo (unspecified) / Duration of Treatment: 1 DaysDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Bunion removal Exclusion Criteria: * Any known allergies to the study design

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Frequently asked questions about MK0966, rofecoxib

What is MK0966 (rofecoxib) used for?

MK0966, also known as rofecoxib, was studied for osteoarthritis, postoperative pain, and pain following arthroscopic surgery. Its clinical program covered musculoskeletal pain conditions, including post-bunionectomy surgery pain. The trials enrolled adults, with osteoarthritis studies requiring participants aged 40 years and older.

Who makes rofecoxib (MK0966)?

Rofecoxib, also called MK0966, was developed by Merck & Company, Inc., which trades under the ticker MRK. Merck sponsored the clinical trial program evaluating the drug across osteoarthritis and postoperative pain indications.

What phase is MK0966 in?

MK0966 (rofecoxib) reached Phase 3 clinical development. Five Phase 3 trials were conducted, all of which are now completed, with no active trials ongoing. The studies together enrolled approximately 1,366 participants.

What clinical trials is rofecoxib (MK0966) in?

Rofecoxib was evaluated in five completed Phase 3 trials, including NCT00390260 in pain following arthroscopic surgery, NCT00092378 in post-bunionectomy surgery pain, and NCT00092365 and NCT00092352 in osteoarthritis. These randomized, double-blind studies enrolled adults aged 18 years and older, or 40 years and older for osteoarthritis.

Is MK0966 the same as rofecoxib?

Yes, MK0966 and rofecoxib refer to the same compound. Merck & Company, Inc. developed it under the MK0966 designation, and it is also identified in trial records as MK0966 with a one-day duration of treatment. Searches for either name refer to the same drug candidate.