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| ID | Type | Description | Link |
|---|---|---|---|
| A3471090 |
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To determine the therapeutic dose range of valdecoxib by comparing the efficacy of three dosing regimens (5 mg, 10 mg and 20 mg once daily) with placebo for relief of the signs and symptoms of osteoarthritis of the knee. To assess safety and tolerability of multiple doses of valdecoxib in patients with osteoarthritis of the knee.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Active Comparator |
| |
| Arm 2 | Active Comparator |
| |
| Arm 3 | Active Comparator |
| |
| Arm 4 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| valdecoxib | Drug | valdecoxib 5 mg tablet by mouth once daily in the morning for 6 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| WOMAC (Western Ontario and McMaster Universities) OA Pain Index | screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6 (final visit) |
| Measure | Description | Time Frame |
|---|---|---|
| patients' and physicians' and 'categorical' global assessment of arthritis | screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6 | |
| WOMAC OA stiffness index | screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6 |
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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 | Funabashi | Chiba | Japan | |||
| 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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| valdecoxib |
| Drug |
valdecoxib 10 mg tablet by mouth once daily in the morning for 6 weeks |
|
| valdecoxib | Drug | valdecoxib 20 mg tablet by mouth once daily in the morning for 6 weeks |
|
| placebo | Drug | placebo tablet by mouth once daily in the morning for 6 weeks |
|
| WOMAC OA physical function index | screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6 |
| WOMAC OA composite index | screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6 |
| WOMAC OA pain index, stiffness index, physical function index, and composite index | screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6 |
| Incidence of and time to withdrawal due to lack of efficacy | weeks 2, 4, and 6 |
| patient's assessment of arthritis pain (Visual Analog Scale, VAS) | screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6 |
| Sakura |
| Chiba |
| Japan |
| Pfizer Investigational Site | Chikushi-gun | Fukuoka | Japan |
| Pfizer Investigational Site | Iizuka | Fukuoka | Japan |
| Pfizer Investigational Site | Kurume | Fukuoka | Japan |
| Pfizer Investigational Site | Yame | Fukuoka | Japan |
| Pfizer Investigational Site | Chitose | Hokkaido | Japan |
| Pfizer Investigational Site | Sapporo | Hokkaido | Japan |
| Pfizer Investigational Site | Kamakura | Kanagawa | Japan |
| Pfizer Investigational Site | Yokohama | Kanagawa | Japan |
| Pfizer Investigational Site | Isahaya | Nagasaki | Japan |
| Pfizer Investigational Site | Hirakata | Osaka | Japan |
| Pfizer Investigational Site | Kanzaki-gun | Saga-ken | Japan |
| Pfizer Investigational Site | Karatsu | Saga-ken | Japan |
| Pfizer Investigational Site | Ogi-gun | Saga-ken | Japan |
| Pfizer Investigational Site | Itabashi-ku | Tokyo | Japan |
| Pfizer Investigational Site | Setagaya-ku | Tokyo | Japan |
| Pfizer Investigational Site | Shinjuku-Ku | Tokyo | Japan |
| Pfizer Investigational Site | Taito-ku | Tokyo | Japan |
| Pfizer Investigational Site | Yoyogi Shibuya-ku | Tokyo | Japan |
| Pfizer Investigational Site | Saga | Japan |
| Pfizer Investigational Site | Tokyo | Japan |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| C406224 | valdecoxib |
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