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

Organon

Status and phase

Completed

Phase 3

Conditions

Rheumatoid Arthritis,Osteoarthritis

Treatments

Drug: MK0663, etoricoxib

Drug: Comparator: Diclofenac sodium

Study type

Interventional

Funder types

Industry

Identifiers

NCT00250445

2005_100

0663-066

Details and patient eligibility

About

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.

Enrollment

23,498 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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