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To compare the efficacy and safety of celecoxib versus ibuprofen in subjects with osteoarthritis (OA) of the knee.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ibuprofen | Experimental |
| |
| Celecoxib | Experimental |
| |
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibuprofen | Drug | 800 mg oral tablet three time daily with meals for 6 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in patient's assessment of arthritis pain according to visual analogue scale (VAS) | Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Vital signs | Weeks 2 and 6 | |
| Physical examination | Week 6 | |
| Laboratory test results |
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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 | Anniston | Alabama | 36207 | 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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| celecoxib |
| Drug |
200 mg oral capsule once daily with morning meal for 6 weeks |
|
| placebo | Other | matched placebo orally for 6 weeks |
|
| Week 6 |
| Adverse events | Weeks 2 and 6 |
| Change from baseline in patient's and physician's global assessment of pain | Weeks 2 and 6 |
| Pain Satisfaction Scale | Days 1-7 |
| Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index | Week 6 |
| Patient Health Questionnaire (PHQ-9) | Week 6 |
| Change from baseline in patient's assessment of arthritis pain according to VAS | Week 2 |
| Phoenix |
| Arizona |
| 85051 |
| United States |
| Pfizer Investigational Site | Anaheim | California | 92804 | United States |
| Pfizer Investigational Site | Long Beach | California | 90806 | United States |
| Pfizer Investigational Site | Paramount | California | 90723 | United States |
| Pfizer Investigational Site | San Diego | California | 92108 | United States |
| Pfizer Investigational Site | DeLand | Florida | 32720 | United States |
| Pfizer Investigational Site | Miami | Florida | 33186 | United States |
| Pfizer Investigational Site | Naples | Florida | 34102 | United States |
| Pfizer Investigational Site | Pembroke Pines | Florida | 33024 | United States |
| Pfizer Investigational Site | St. Petersburg | Florida | 33710 | United States |
| Pfizer Investigational Site | Chicago | Illinois | 60610 | United States |
| Pfizer Investigational Site | Evansville | Indiana | 47712 | United States |
| Pfizer Investigational Site | Las Vegas | Nevada | 89102 | United States |
| Pfizer Investigational Site | Edison | New Jersey | 08817 | United States |
| Pfizer Investigational Site | South Plainfield | New Jersey | 07080 | United States |
| Pfizer Investigational Site | Albuquerque | New Mexico | 87109 | 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 | Cincinnati | Ohio | 45242 | United States |
| Pfizer Investigational Site | Columbus | Ohio | 43124 | United States |
| Pfizer Investigational Site | Tulsa | Oklahoma | 74136 | United States |
| Pfizer Investigational Site | Altoona | Pennsylvania | 16601 | United States |
| Pfizer Investigational Site | Jenkintown | Pennsylvania | 19046 | United States |
| Pfizer Investigational Site | Newtown | Pennsylvania | 18940 | United States |
| Pfizer Investigational Site | Warwick | Rhode Island | 02886 | United States |
| Pfizer Investigational Site | Charleston | South Carolina | 29407 | United States |
| Pfizer Investigational Site | Greer | South Carolina | 29651 | United States |
| Pfizer Investigational Site | Mt. Pleasant | South Carolina | 29464 | United States |
| Pfizer Investigational Site | Johnson City | Tennessee | 37601 | United States |
| Pfizer Investigational Site | Dallas | Texas | 75235 | United States |
| Pfizer Investigational Site | Layton | Utah | 84041 | United States |
| Pfizer Investigational Site | Danville | Virginia | 24541 | 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 |
|---|---|
| D007052 | Ibuprofen |
| D000068579 | Celecoxib |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| 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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