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The purpose of this study is to examine the effects of Nexium at a dose of 40mg administered orally compared to intravenously on the maximum acid output in subjects with symptoms of Gastroesophageal reflux disease (GERD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | IV Nexium |
|
| 2 | Experimental | Oral Nexium |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esomeprazole | Drug | 40mg Intravenous infusion over 3 minutes |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| To compare the maximum acid output during pentagastrin stimulation after 10 days of Nexium dosing administered orally with 10 days dosing via intravenous administration. | Every 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| To compare basal acid output at steady state and when switching between Oral and IV adminstration of Nexium. | Post Day 10 | |
| To compare maximum acid output when switching between Oral and IV adminstration of Nexium | Post Day 10 |
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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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| Esomeprazole | Drug | 40mg Oral |
|
|
| Safety assessment via adverse event recording | At each visit |
| 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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