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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: All Enrolled Participants | Experimental | All participants will receive open-label etoricoxib 60 mg orally daily during Part 1. |
|
| Part 2: Etoricoxib | Experimental |
| |
| Part 2: Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etoricoxib | Drug | One 60-mg tablet orally daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Time to Loss of Efficacy in the Double Blind Withdrawal Period (Part 2) | Week 3 to Week 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants who Achieve ≥30% Reduction in Pain During Part I | Week 1 to Week 3 | |
| Change in Mean of Daily Pain Scores | Week 1 to Week 7 | |
| Proportion of Participants Meeting Criteria for Loss of Efficacy in Part 2 |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D000077613 | Etoricoxib |
| ID | Term |
|---|---|
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
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| Placebo for etoricoxib | Drug | One 60-mg tablet orally daily |
|
| Week 3 to Week 7 |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |