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| ID | Type | Description | Link |
|---|---|---|---|
| D9615C00012 |
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This study looks at the effect on basal and pentagastrin-stimulated acid output of 40 mg Esomeprazole (Nexium) administered orally and intravenously as a 15-minute infusion to people with symptoms of Gastroesophageal Reflux Disease (GERD)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | 20mg oral |
|
| 2 | Active Comparator | 15 minute intravenous infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esomeprazole | Drug | 20mg oral |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| The maximal acid output (MAO) during pentagastrin stimulation after 10 days administration of 40 mg esomeprazole for both study periods. | MAO will be assessed after 10 days of treatment (Day 11 or Day 20) |
| Measure | Description | Time Frame |
|---|---|---|
| Basal acid output (BAO) after 10 days administration of 40 mg esomeprazole for both study periods. (Day 11 or Day 20) | BAO will be assessed after 10 days of treatment | |
| To compare MAO when switching (after Day 2 in the second study period versus after Day 10 in the first study period) from oral to intravenous dosing and from intravenous to oral dosing. |
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Inclusion Criteria:
Exclusion Criteria:
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| Esomeprazole |
| Drug |
15 minute intravenous infusion |
|
|
| Assessments at Day 2 and after Day 10 (Day 11 or Day 20) |
| To evaluate the safety of intravenous esomeprazole in subjects with symptoms of GERD. | Safety assessments throughout the study |
| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D064098 | Esomeprazole |
| 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 |
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