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| ID | Type | Description | Link |
|---|---|---|---|
| A3471101 |
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To evaluate the efficacy, safety, and tolerability of valdecoxib by comparing valdecoxib 10 mg daily (QD) with naproxen 500 mg twice daily (BID) in treating the signs and symptoms of osteoarthritis (OA) of the knee or hip. The study was designed to collect comparative information for the local population (Taiwan).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Active Comparator |
| |
| Arm 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| valdecoxib | Drug | valdecoxib 10 mg tablet by mouth once daily for 6 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Patient's Assessment of Arthritis Pain (Osteoarthritis-Pain VAS) | Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Western Ontario and McMaster Universities Osteoarthritis (WOMAC OA) Composite Index | Week 2 and Week 6 | |
| WOMAC OA physical function | Week 2 and Week 6 | |
| WOMAC OA pain index |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Kweishan | Taoyuan | Taiwan | |||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| naproxen |
| Drug |
naproxen 500 mg capsule by mouth twice daily for 6 weeks |
|
| Week 2 and Week 6 |
| WOMAC OA stiffness index | Week 2 and Week 6 |
| Patient's Assessment of Arthritis Pain (Osteoarthritis-Pain VAS) | Week 2 |
| Patient's Global Assessment of Arthritis | Week 2 and Week 6 |
| Physician's Global Assessment of Arthritis | Week 2 and Week 6 |
| Kaohsiung City |
| Taiwan |
| Pfizer Investigational Site | Taichung | Taiwan |
| Pfizer Investigational Site | Taipei | Taiwan |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D020370 | Osteoarthritis, Knee |
| D015207 | Osteoarthritis, Hip |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| C406224 | valdecoxib |
| D009288 | Naproxen |
| ID | Term |
|---|---|
| D009280 | Naphthaleneacetic Acids |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
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