A Study to Evaluate the Safety of an Investigational Drug (Etoricoxib) in Patients With Osteoarthritis (OA) or Rheumatoid Arthritis (RA)(0663-066)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

23498 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2006-05-31

Brief Summary

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The study is designed to compare the risk of cardiovascular events (heart attacks, strokes) in patients receiving either etoricoxib or diclofenac. It will also compare the gastrointestinal tolerability of the two medicines. The study will be conducted in patients with either rheumatoid or osteo-arthritis.

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Detailed Description

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Conditions

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Rheumatoid Arthritis,Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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MK0663, etoricoxib

Intervention Type DRUG

Comparator: Diclofenac sodium

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patient has a clinical diagnosis of either Osteoarthritis or Rheumatoid Arthritis and in the opinion of the investigator will require chronic nonsteroidal anti-inflammatory or COX-2 inhibitor therapy for at least 1.5 years

Exclusion Criteria

* Concurrent medical or arthritic disease that could confound or interfere with efficacy evaluation.
* Concomitant therapy of warfarin, heparin, high-dose aspirin (\>100 mg/day).
* Impaired kidney function, clinical gastrointestinal malabsorption, congestive heart failure with symptoms that occur at rest, unstable angina, uncontrolled high blood pressure, active hepatitis/hepatic disease

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No