Etoricoxib vs. Diclofenac in OA
Information source: Merck
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteoarthritis
Intervention: MK0663, etoricoxib / Duration of Treatment: 6 Weeks (Drug); Comparator: diclofenac sodium / Duration of Treatment: 6 Weeks (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Merck Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
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.
Clinical Details
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
Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: 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: The study drug will be safe and well tolerated during the course of the study.
Eligibility
Minimum age: 40 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Additional Information
Related publications: 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.
Starting date: May 2002
Ending date: December 2002
Last updated: October 5, 2007
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