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To compare the efficacy and safety of celecoxib versus placebo for the treatment of knee osteoarthritis (OA) in patients who were unresponsive to prescription strength naproxen and ibuprofen or who could not tolerate prescription strength naproxen and ibuprofen
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
| |
| B | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Celecoxib | Drug | 200 mg oral capsule once daily with morning meal for 6 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Patient's Assessment of Arthritis Pain, according to visual analog scale (VAS) | Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient's Assessment of Arthritis Pain, according to VAS | Week 2 | |
| The Western Ontario and McMaster Universities Osteoarthritis Index | Week 6 | |
| Patient's and Physician's Global Assessment of Arthritis |
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Inclusion Criteria:
Inclusion criteria:
Exclusion 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 | Birmingham | Alabama | 35235 | United States | ||
| 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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| Placebo |
| Other |
Matched oral placebo for 6 weeks |
|
| Weeks 2 and 6 |
| The Medical Outcomes Study Sleep Scale | Week 6 |
| Adverse events | Weeks 0-6 |
| Laboratory tests | Week 6 |
| Vital signs | Week 6 |
| Physical examination | Week 6 |
| Serious adverse events | Up to 30 days after last dose |
| Buena Park |
| California |
| 90620 |
| United States |
| Pfizer Investigational Site | Denver | Colorado | 80204 | United States |
| Pfizer Investigational Site | Washington D.C. | District of Columbia | 20006 | United States |
| Pfizer Investigational Site | Longwood | Florida | 32779 | United States |
| Pfizer Investigational Site | Miami | Florida | 33186 | United States |
| Pfizer Investigational Site | Zephyrhills | Florida | 33540 | United States |
| Pfizer Investigational Site | Boise | Idaho | 83704 | United States |
| Pfizer Investigational Site | Boise | Idaho | 83706 | United States |
| Pfizer Investigational Site | Morton Grove | Illinois | 60053 | United States |
| Pfizer Investigational Site | Wichita | Kansas | 67206 | United States |
| Pfizer Investigational Site | Wichita | Kansas | 67214 | United States |
| Pfizer Investigational Site | Wheaton | Maryland | 20902 | United States |
| Pfizer Investigational Site | Springfield | Missouri | 65807 | United States |
| Pfizer Investigational Site | Bozeman | Montana | 59715 | United States |
| Pfizer Investigational Site | Trenton | New Jersey | 08611 | United States |
| Pfizer Investigational Site | Binghamton | New York | 13901 | United States |
| Pfizer Investigational Site | Brooklyn | New York | 11203 | United States |
| Pfizer Investigational Site | New York | New York | 10022-1009 | United States |
| Pfizer Investigational Site | Cary | North Carolina | 27609 | United States |
| Pfizer Investigational Site | Winston-Salem | North Carolina | 27103 | United States |
| Pfizer Investigational Site | Bismarck | North Dakota | 58506 | United States |
| Pfizer Investigational Site | Eugene | Oregon | 97401 | United States |
| Pfizer Investigational Site | Portland | Oregon | 97239 | United States |
| Pfizer Investigational Site | Duncansville | Pennsylvania | 16635-0909 | United States |
| Pfizer Investigational Site | Johnstown | Pennsylvania | 15904 | United States |
| Pfizer Investigational Site | Warwick | Rhode Island | 02886 | United States |
| Pfizer Investigational Site | Charleston | South Carolina | 29407 | United States |
| Pfizer Investigational Site | New Tazewell | Tennessee | 37825 | United States |
| Pfizer Investigational Site | San Antonio | Texas | 78229 | United States |
| Pfizer Investigational Site | Arlington | Virginia | 22203 | United States |
| Pfizer Investigational Site | Norfolk | Virginia | 23502 | United States |
| Pfizer Investigational Site | Seattle | Washington | 98166 | United States |
| 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 |
|---|---|
| D000068579 | Celecoxib |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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