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The aim of the current study is to replicate the COXA-0508-258 study in a multicenter, US setting, using a lower dose of ASA. It is expected that this study will not only confirm the results of the 258 study but show that the incidence of UGI ulcers on celecoxib is significantly less than on traditional NSAIDs and the incidence of UGI ulcers on celecoxib increases with the addition of ASA, but still is lower than traditional NSAIDs plus/minus ASA. This 7-day study is designed to compare the incidence of gastroduodenal ulcers associated with celecoxib 200 mg QD and low dose aspirin 81 mg QD and with naproxen 500 mg BID plus low dose aspirin 81 mg QD in healthy adults(50-75 years of age).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Celecoxib | Drug | |||
| Naproxen | Drug | |||
| ASA | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Compare the incidence of gastroduodenal endoscopic ulcers between celecoxib 200 mg QD plus ASA 81 mg QD vs. naproxen 500 mg BID plus ASA 81 mg QD in healthy subjects (50-75 years old). |
| Measure | Description | Time Frame |
|---|---|---|
| Compare the incidence of gastroduodenal endoscopic ulcers between celecoxib plus ASA vs placebo plus ASA in healthy subjects (50-75 years of age) Compare the incidence of gastroduodenal endoscopic ulcers between naproxen plus ASA vs. placebo plus ASA |
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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 | Anaheim | California | 92801 | United States | ||
| Pfizer Investigational Site |
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| San Diego |
| California |
| 92123 |
| United States |
| Pfizer Investigational Site | Farmington | Connecticut | 06030-0001 | United States |
| Pfizer Investigational Site | Waterbury | Connecticut | 06708 | United States |
| Pfizer Investigational Site | Jupiter | Florida | 33458 | United States |
| Pfizer Investigational Site | Miami | Florida | 33173 | United States |
| Pfizer Investigational Site | Ocoee | Florida | 34761 | United States |
| Pfizer Investigational Site | Pembroke Pines | Florida | 33024 | United States |
| Pfizer Investigational Site | Chicago | Illinois | 60612-7323 | United States |
| Pfizer Investigational Site | Newburgh | Indiana | 47630 | United States |
| Pfizer Investigational Site | Davenport | Iowa | 52807 | United States |
| Pfizer Investigational Site | Metairie | Louisiana | 70001 | United States |
| Pfizer Investigational Site | Chevy Chase | Maryland | 20815 | United States |
| Pfizer Investigational Site | New York | New York | 10021 | United States |
| Pfizer Investigational Site | Raleigh | North Carolina | 27612 | United States |
| Pfizer Investigational Site | Wilmington | North Carolina | 28401 | United States |
| Pfizer Investigational Site | Cincinnati | Ohio | 45219 | United States |
| Pfizer Investigational Site | Duncansville | Pennsylvania | 16635 | United States |
| Pfizer Investigational Site | Chattanooga | Tennessee | 37404 | United States |
| Pfizer Investigational Site | Houston | Texas | 77074 | United States |
| Pfizer Investigational Site | Houston | Texas | 77090 | United States |
| Pfizer Investigational Site | Charlottesville | Virginia | 22903 | United States |
| Pfizer Investigational Site | Chesapeake | Virginia | 23320-1706 | United States |
| ID | Term |
|---|---|
| D010437 | Peptic Ulcer |
| ID | Term |
|---|---|
| D004378 | Duodenal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D013272 | Stomach Diseases |
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| ID | Term |
|---|---|
| D000068579 | Celecoxib |
| D009288 | Naproxen |
| 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 |
| D009280 | Naphthaleneacetic Acids |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
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