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...
Date First Received: October 5, 2007
Last Updated: October 5, 2007
Verified by: Merck, October 2007
Clinical Trial Phase: Phase 3 | Start Date: May 2002
Overall Status: Completed
Estimated Enrollment: 500
Brief Summary
Official Title: “A Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Etoricoxib 60 mg and Diclofenac Sodium 150 mg in Patient With Osteoarthritis of the Knee or Hip”
Condition Keyword(s):
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.
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: MK0663, etoricoxib / Duration of Treatment: 6 Weeks
- Drug: Comparator: diclofenac sodium / Duration of Treatment: 6 Weeks
Outcome Measures for this Clinical Trial
Primary Measures
- 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 Measures
- The study drug will be safe and well tolerated during the course of the study.
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 40 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Merck
Overall Clinical Trial Officials and Contacts
Medical Monitor Study Director Merck
Related Publications
References
Zacher J, Feldman D, Gerli R, Scott D, Hou SM, Uebelhart D, Rodger IW, Ozturk ZE; etoricoxib OA study group. A comparison of the therapeutic efficacy and tolerability of etoricoxib and diclofenac in patients with osteoarthritis. Curr Med Res Opin. 2003;19(8):725-36.
Additional Information
Information obtained from ClinicalTrials.gov on August 08, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00542087
Study ID Number: 2007_625
ClinicalTrials.gov Identifier: NCT00542087
Health Authority: Belgium: Directorate general for the protection of Public health: Medicines
Clinical Trials Authorship and Review
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