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| ID | Type | Description | Link |
|---|---|---|---|
| D9617C00014 |
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Nonsteroidal anti-inflammatory drugs (NSAIDS) are often associated with gastric ulcers. This study looks at the prevention of these gastric ulcers, in patients deemed to be at risk, with either esomeprazole 40 mg once daily; esomeprazole 20 mg once daily.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 20mg capsule once daily |
|
| 2 | Experimental | 40mg capsule daily |
|
| 3 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esomeprazole | Drug | 20mg oral capsule daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess the efficacy of esomeprazole 40 mg qd versus placebo and esomeprazole 20 mg qd versus placebo for up to 6 months of treatment for the prevention of gastric (and duodenal) ulcers in patients receiving daily NSAID therapy. | Assessments at Week 0, Week 4, Week 12, Week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator assessed symptoms, defined as control of NSAID-associated GI symptoms for up to 6 months of treatment with esomeprazole 40 mg qd versus placebo and esomeprazole 20 mg qd versus placebo in patients receiving daily NSAID therapy. | Assessments at Week 0, Week 4, Week 12, Week 26 | |
| Safety and tolerability of esomeprazole 40 mg qd versus placebo and esomeprazole 20 mg qd versus placebo when administered for up to 6 months to patients receiving daily NSAID therapy. |
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Inclusion Criteria:
Exclusion Criteria:
1. History of esophageal, gastric or duodenal surgery, except the simple closure of an ulcer.
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| Name | Affiliation | Role |
|---|---|---|
| Paula Fernstrom | Nexium Global Product Director, AstraZeneca | Study Director |
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| ID | Term |
|---|---|
| D013276 | Stomach Ulcer |
| ID | Term |
|---|---|
| D010437 | Peptic Ulcer |
| D004378 | Duodenal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D064098 | Esomeprazole |
| ID | Term |
|---|---|
| D009853 | Omeprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
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| Esomeprazole |
| Drug |
40mg oral capsule daily |
|
|
| Placebo | Drug |
|
| Assessments at Week 0, Week 4, Week 12, Week 26 |
| D004066 |
| Digestive System Diseases |
| D013272 | Stomach Diseases |
| 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 |