Rofecoxib

Overview

Rofecoxib is used for the treatment of osteoarthritis, rheumatoid arthritis, acute pain in adults, and primary dysmenorrhea, as well as acute treatment of migraine attacks with or without auras. Rofecoxib is a solid. This compound belongs to the stilbenes. These are organic compounds containing a 1,2-diphenylethylene moiety. Stilbenes (C6-C2-C6 ) are derived from the common phenylpropene (C6-C3) skeleton building block. The introduction of one or more hydroxyl groups to a phenyl ring lead to stilbenoids. Rofecoxib has a half-life of 17 hours and its mean oral bioavailability at therapeutically recommended doses of 125, 25, and 50 mg is approximately 93%. The proteins that rofecoxib target include elastin and prostaglandin G/H synthase 2. Cytochrome P450 1A2, Cytochrome P450 3A4, Cytochrome P450 2C9, Cytochrome P450 2C8, and Prostaglandin G/H synthase 1 are known to metabolize rofecoxib. On September 30, 2004, Merck voluntarily withdrew rofecoxib from the market because of concerns about increased risk of heart attack and stroke associated with long-term, high-dosage use.

Indication

For the treatment of osteoarthritis, rheumatoid arthritis, acute pain in adults, and primary dysmenorrhea, as well as acute treatment of migraine attacks with or without auras.

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
CI(R)CA : Coumadin Interaction With Rofecoxib, Celecoxib and Acetaminophen	2013/01/08	NCT01762891	Not Applicable	Completed	Hospital Universitario Pedro Ernesto
Coxib-inhibition of Duodenal Polyp Growth in FAP	2009/02/16	NCT00844727	Phase 2	Terminated	Oslo University Hospital
A Double-blind, Double-dummy, Multicenter, Randomized Study of the Efficacy and Tolerability of Valdecoxib 40 mg Versus Rofecoxib 50 mg in Treating the Symptoms of Ankle Sprain	2008/04/14	NCT00657449	Phase 4	Terminated	Pfizer
Safety of Lumiracoxib in Patients With Osteoarthritis	2008/03/18	NCT00637949	Phase 3	Completed	Novartis
Barrett's Esophagus - 315 - 3 Way Cross Over	2008/03/18	NCT00637988	Phase 4	Completed	AstraZeneca
A Four-Week Study Comparing Acetaminophen Extended Release and Rofecoxib in the Treatment of Osteoarthritis of the Knee	2007/12/06	NCT00568295	Phase 3	Completed	Johnson & Johnson Consumer and Personal Products Worldwide
Study of Rofecoxib and Prolonged Constant Infusion of Gemcitabine in the Polychemotherapy Treatment of Advanced NSCLC	2006/10/11	NCT00385606	Phase 2	Completed	National Cancer Institute, Naples
An End to the Yom Kippur (and Ramadan) Headache	2005/12/07	NCT00263094	Not Applicable	Completed	Sheba Medical Center
A Safety Trial to Compare Different Analgesics in Combination With Low Dose Aspirin to Study Their Bleeding Properties and Their Effects on the Stomach	2005/12/05	NCT00261586	Phase 4	Completed	Johnson & Johnson Consumer and Personal Products Worldwide
A Study of Rofecoxib Versus Naproxen in the Treatment of Chinese Patient With Rheumatoid Arthritis (0966-231)	2005/09/12	NCT00157872	Phase 4	Completed	Merck Sharp & Dohme LLC

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

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