An Investigational Drug in Patients With Osteoarthritis of the Knee or Hip
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 (Drug); Comparator: diclofenac (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Merck Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
Summary
The purpose of this study is to compare the safety and efficacy of an investigational
medication to an approved drug in the treatment of osteoarthritis of the knee or hip in
patients who continue to have pain after stopping current medications.
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 Patients With Osteoarthritis of the Knee or Hip
Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Efficacy in the treatment of osteoarthritis of the knee or hip during a six week treatment period as assessed by the WOMAC pain subscale.
Secondary outcome: Safety and tolerability.
Detailed description:
The duration of treatment is 6 weeks.
Eligibility
Minimum age: 40 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Male/female patients at least 40 years of age with a diagnosis of osteoarthritis of
the knee or hip who continue to have pain after stopping current medication.
Exclusion Criteria:
- Any known allergy to the study drug.
Locations and Contacts
Call for International Site Information, Horsham, Pennsylvania 19044, United States
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: March 2002
Last updated: September 5, 2006
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