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Nonsteroidal anti-inflammatory drugs (NSAIDS) are often associated with gastric ulcers. This study looks at the treatment of these gastric ulcers with one of the three following treatment groups: esomeprazole 40 mg once daily; esomeprazole 20 mg once daily; or ranitidine 150 mg twice daily.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 20mg Oral tablet daily |
|
| 2 | Experimental | 40mg oral tablet daily |
|
| 3 | Active Comparator | 150mg oral twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esomeprazole | Drug | 20mg Oral tablet once daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess the safety and efficacy of esomeprazole 40 mg qd versus ranitidine 150 mg bid through 8 weeks of treatment for the healing of gastric ulcers in patients receiving daily NSAID therapy. Healing is defined as the absence of gastric ulcers. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient and investigator assessed GI symptoms for up to 8 weeks of treatment. | Assessments at week 0, week 4 and week 8 | |
| Safety and tolerability of the treatments for 8 weeks of treatment. | Assessments at week 0, week 4 and week 8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paula Fernstrom | Nexium Global Product Director, AstraZeneca | Study Director |
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| Ranitidine | Drug | 150mg oral twice daily |
|
|
| Esomeprazole | Drug | 40mg oral tablet once daily |
|
|
| ID | Term |
|---|---|
| D013276 | Stomach Ulcer |
| ID | Term |
|---|---|
| D010437 | Peptic Ulcer |
| D004378 | Duodenal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D013272 | Stomach Diseases |
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| ID | Term |
|---|---|
| D064098 | Esomeprazole |
| D011899 | Ranitidine |
| ID | Term |
|---|---|
| D009853 | Omeprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D005663 | Furans |
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