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Rofecoxib

Phase 3

Osteoarthritis of the Knee | Small molecule | Musculoskeletal |Johnson & Johnson|Last Updated: Aug 22, 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment403

FDA Designations

No designations recorded

Clinical trial landscape

Rofecoxib · 1 trial · 1 indication

Phase 3 1
NCT00568295A Four-Week Study Comparing Acetaminophen Extended Release and Rofecoxib in the Treatment of Osteoarthritis of the KneeOsteoarthritis of the Knee
COMPLETED403 Analytics
PHASE3COMPLETED
A Four-Week Study Comparing Acetaminophen Extended Release and Rofecoxib in the Treatment of Osteoarthritis of the Knee
Osteoarthritis of the KneeUnlock trial analytics

Study Endpoints

Primary Endpoints

Change from Baseline in the Western Ontario and McMaster Universities (WOMAC) pain subscale score at week 4 in the per protocol study population.
Four Weeks

Secondary Endpoints

Change from Baseline in the WOMAC pain subscale score
Weeks 1 and 2
Change from baseline in the WOMAC stiffness and physical function subscale scores
Weeks 1, 2 and 4
Investigator's impression of therapeutic response
Weeks 1, 2, and 4
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AcetaminophenEXPERIMENTALAcetaminophen Extended Release: Caplets 650 mg x 2, oral, C-112-10AP
Refecoxib 12.5 mgACTIVE_COMPARATORRofecoxib: Capsules 12.5 mg, oral, C-904-1A
Rofecoxib 12.5 x 2ACTIVE_COMPARATORRofecoxib: Capsules 12.5 mg x 2, oral, C-904-1A

Interventions

NameTypeDescription
acetaminophenDRUGAcetaminophen Extended Release: Caplets 650 mg x 2, oral, C-112-10AP - Subjects were instructed to dose every eight hours according to the specified dosing schedule and to record the designated parameters in the subject diary on a daily basis throughout the course of the study until the final visit at the end of Week 4 or until discontinuation of study medication.
RofecoxibDRUGRofecoxib: Capsules 12.5 mg, oral, C-904-1A - - Subjects were instructed to dose every eight hours according to the specified dosing schedule and to record the designated parameters in the subject diary on a daily basis throughout the course of the study until the final visit at the end of Week 4 or until discontinuation of study medication.
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Eligibility Criteria

Age Range40 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Symptomatic idiopathic osteoarthritis of the knee for a minimum of six months duration requiring treatment with either an analgesic or anti-inflammatory agent on a regular basis (greater than or equal to three days/week) for at least three months. * A history of osteoarthritis...

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Frequently asked questions about Rofecoxib

What is Rofecoxib used for?

Rofecoxib is an investigational small molecule being studied for the treatment of osteoarthritis of the knee. It is a nonsteroidal anti-inflammatory drug under development by Johnson & Johnson. The drug is intended for patients with this condition, and it has been evaluated in a Phase 3 clinical trial.

Who makes Rofecoxib?

Rofecoxib is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker JNJ. The drug is a small molecule intended for the treatment of osteoarthritis of the knee. It has been studied in a Phase 3 clinical trial.

What phase is Rofecoxib in?

Rofecoxib is in Phase 3 clinical development. It has completed one Phase 3 trial for osteoarthritis of the knee, and no active trials are currently listed. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is Rofecoxib in?

Rofecoxib has been studied in one completed Phase 3 clinical trial, identified as NCT00568295. This trial was a four-week study comparing acetaminophen extended release and rofecoxib in the treatment of osteoarthritis of the knee. The trial enrolled 403 participants and was randomized, double-blind, and active-controlled.

Is Rofecoxib the same as acetaminophen?

No, Rofecoxib is not the same as acetaminophen. Rofecoxib is an investigational drug being developed by Johnson & Johnson for osteoarthritis of the knee. In a clinical trial, it was compared against acetaminophen extended release as an active control, but the two are distinct medications.