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To evaluate the small bowel lesion pattern associated with celecoxib alone versus ibuprofen plus omeprazole
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
| |
| B | Placebo Comparator |
| |
| C | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Celecoxib | Drug | 200 mg oral capsule twice daily for 2 weeks |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of mucosal breaks in the small bowel for each subject | Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Day 30 | |
| Laboratory tests | Day 30 | |
| Vital signs |
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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 | Scottsdale | Arizona | 85259 | 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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| Other |
Matched placebo for 2 weeks |
|
| Ibuprofen plus Omeprazole | Drug | ibuprofen 800 mg oral tablet three times daily plus omeprazole 20 mg oral capsule once daily for 2 weeks |
|
| Day 30 |
| Correlation of number of mucosal breaks in the small bowel for each patient with the result of the fecal calprotectin test | Day 30 |
| Percentage of subjects with gastric mucosal breaks and the number of mucosal breaks | Day 30 |
| Change from screening visit in hemoglobin and hematocrit | Day 30 |
| Correlation of the number of gastric mucosal breaks with the number of small bowel mucosal breaks | Day 30 |
| Physical examination | Day 30 |
| Percentage of subjects with >=1 mucosal breaks | Day 30 |
| Total number of small bowel lesions with or without hemorrhage | Day 30 |
| Percentage of subjects with visible blood in the small bowel (without visualized lesions in the small bowel) | Day 30 |
| Change in Patient General Questionnaire Visual Analog Scale from Day 16 | Day 30 |
| Change in Severity of Dyspepsia Assessment questionnaire from Day 16 | Day 30 |
| La Jolla |
| California |
| 92037 |
| United States |
| Pfizer Investigational Site | Los Angeles | California | 90033 | United States |
| Pfizer Investigational Site | Los Angeles | California | 90073 | United States |
| Pfizer Investigational Site | Jupiter | Florida | 33458 | United States |
| Pfizer Investigational Site | Miami | Florida | 33173 | United States |
| Pfizer Investigational Site | Chicago | Illinois | 60612 | United States |
| Pfizer Investigational Site | Rockford | Illinois | 61107 | United States |
| Pfizer Investigational Site | Ann Arbor | Michigan | 48109-0362 | United States |
| Pfizer Investigational Site | New York | New York | 10021 | United States |
| Pfizer Investigational Site | Portland | Oregon | 97239 | United States |
| Pfizer Investigational Site | Nashville | Tennessee | 37232-5280 | United States |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D007410 | Intestinal Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000068579 | Celecoxib |
| D007052 | Ibuprofen |
| D009853 | Omeprazole |
| 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 |
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D011725 | Pyridines |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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