This two-part study will evaluate the effectiveness of etoricoxib in controlling pain in participants with osteoarthritis who are experiencing inadequate response to their current treatments. In Part 1, all participants will receive open-label etoricoxib 60 mg daily. Those participants who experience a clinically meaningful response to etoricoxib 60 mg daily within two weeks will be eligible to enter the double-blind withdrawal period (Part II). Responders entering Part 2 will be randomized in a 1:1 ratio to receive either etoricoxib 60 mg or placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
One 60-mg tablet orally daily
One 60-mg tablet orally daily
Mean Time to Loss of Efficacy in the Double Blind Withdrawal Period (Part 2)
Time frame: Week 3 to Week 7
Proportion of Participants who Achieve ≥30% Reduction in Pain During Part I
Time frame: Week 1 to Week 3
Change in Mean of Daily Pain Scores
Time frame: Week 1 to Week 7
Proportion of Participants Meeting Criteria for Loss of Efficacy in Part 2
Time frame: Week 3 to Week 7
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