Etoricoxib vs. Diclofenac in OA (0663-805)(COMPLETED)

Phase 3

Completed

• Conditions: Osteoarthritis

• Registration Number: NCT00542087
• Lead Sponsor: Organon and Co

Brief Summary

To compare the safety and tolerability of etoricoxib and diclofenac sodium in the treatment of osteoarthritis of the knee or hip during a six week period.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-03-22
• Primary Completion: 2002-12-20
• Study Completion: 2002-12-20
• Study First Submitted: 2007-10-05
• Study First Submitted QC: 2007-10-05
• Study First Posted: 2007-10-10
• Status Verified: 2022-02
• Last Update Submitted: 2024-08-12
• Last Update Posted: 2024-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 516

Inclusion Criteria

• Patient is at least 40 years old and diagnosed with osteoarthritis of the knee or hip
• Has a history of treatment with NSAIDs with positive therapeutic benefit
• Agree to limit alcohol intake to less than 7 drinks per week and avoid unusual strenuous activity
• Females who are able to have children must have negative urine pregnancy tests

Exclusion Criteria

• Has rheumatoid arthritis, lupus, Paget's disease affecting the study joint, or Wilson's disease
• History of acute ligament or meniscus damage to the study joint (knee or hip) within the past 2 years or arthroscopic surgery on the affected study joint with the past 6 months
• Requires joint replacement

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
This study will assess the effectiveness of the study drug vs. a comparator to treat successfully OA-related joint pain (judged by WOMAC pain subscale).

Secondary Outcome Measures

Name	Time	Method
The study drug will be safe and well tolerated during the course of the study.