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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 · 7 trials · 2 indications

Phase 3 7
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
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

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.

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 -
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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, is an investigational small molecule being studied for the treatment of osteoarthritis, postoperative pain, and pain following arthroscopic surgery. It is in Phase 3 clinical development for these musculoskeletal and pain-related conditions.

Who makes MK0966 (rofecoxib)?

MK0966 (rofecoxib) is being developed by Merck & Company, Inc., a pharmaceutical company listed on the stock exchange under the ticker symbol MRK. Merck is conducting clinical trials to evaluate the drug's safety and efficacy in patients with osteoarthritis and various pain conditions.

What phase is MK0966 (rofecoxib) in?

MK0966 (rofecoxib) is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied in completed Phase 3 trials for osteoarthritis, postoperative pain, and pain following arthroscopic surgery.

What clinical trials has MK0966 (rofecoxib) been in?

MK0966 (rofecoxib) has been studied in five completed Phase 3 clinical trials. These include NCT00092313 for postoperative dental pain, NCT00092352 and NCT00092365 for osteoarthritis, and NCT00390260 for pain following arthroscopic surgery. The trials enrolled a total of 1,366 participants.

Is MK0966 the same as rofecoxib?

Yes, MK0966 is the same as rofecoxib. The drug is referred to by both names in clinical research. Rofecoxib is the generic name, while MK0966 is the investigational code name used by the developer, Merck & Company, Inc.

What is the therapeutic area of MK0966 (rofecoxib)?

MK0966 (rofecoxib) falls under the musculoskeletal therapeutic area. It is being developed as a small molecule treatment for conditions such as osteoarthritis and various types of pain, including postoperative pain and pain following arthroscopic surgery.