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

Phase 3

Completed

• Conditions: Rheumatoid Arthritis,Osteoarthritis

• Registration Number: NCT00250445
• Lead Sponsor: Organon and Co

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-01
• Study First Submitted: 2005-11-07
• Study First Submitted QC: 2005-11-07
• Study First Posted: 2005-11-08
• Primary Completion: 2006-05
• Study Completion: 2006-05
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-07
• Last Update Posted: 2022-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23498

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incidence of Confirmed Thrombotic Cardiovascular Serious Adverse Experiences based on combined data from this trial and MK0663 Protocols 061 & 072 (GI Tolerability in OA Patients and GI Tolerability Study in RA Patients ), respectively.

Secondary Outcome Measures

Name	Time	Method
Incidence of Confirmed Thrombotic Cardiovascular Serious Adverse Experiences from this trial alone. Gastrointestinal tolerability based on the percentage of patients that discontinue for clinical or laboratory gastrointestinal adverse experiences.