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This study was performed to demonstrate that treatment with valdecoxib 10 mg daily (QD) was at least as effective as with naproxen 500 mg twice daily (BID), a standard non-steroidal anti-inflammatory drug (NSAID), when taken for 6 weeks in Korean subjects with symptomatic osteoarthritis (OA) of the knee. Secondary objectives were to assess the overall safety and tolerability of valdecoxib 10 mg QD taken for 6 weeks in Korean subjects with symptomatic OA of the knee.
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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 using a Visual Analogue Scale (OA-Pain VAS) | Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| WOMAC OA Physical Function | Week 2 and Week 6 | |
| WOMAC OA Stiffness Index | Week 2 and Week 6 | |
| Patient's Assessment of Arthritis Pain using a Visual Analogue Scale (OA-Pain VAS) |
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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 | Anyang | 431-070 | South Korea | |||
| 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 |
| Patient's Global Assessment of Arthritis Pain using a Visual Analogue Scale (OA-Pain VAS) | Week 2 and Week 6 |
| adverse events | Continuous |
| Physician's Global Assessment of Arthritis Pain | Week 2 and Week 6 |
| WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) Osteoarthritis (OA) Composite Index | Week 2 and Week 6 |
| WOMAC OA Pain Index | Week 2 and Week 6 |
| Gwangju |
| 501-757 |
| South Korea |
| Pfizer Investigational Site | Incheon | 405-760 | South Korea |
| Pfizer Investigational Site | Pusan | 602-739 | South Korea |
| Pfizer Investigational Site | Seoul | 110-744 | South Korea |
| Pfizer Investigational Site | Seoul | 137-701 | South Korea |
| Pfizer Investigational Site | Seoul | 138-736 | South Korea |
| Pfizer Investigational Site | Seoul | 152-703 | South Korea |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| 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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