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This study compares 4 weeks of treatment with Esomeprazole 20 mg once daily to Placebo in the treatment of Upper Abdominal Pain in patients with Symptomatic Gastroesophageal Reflux Disease (sGERD)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 20mg once daily |
|
| 2 | Placebo Comparator | Oral once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esomeprazole | Drug | 20mg Oral Once Daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| To demonstrate a difference between esomeprazole 20 mg once daily and placebo qd in the resolution and relief of upper abdominal pain after 4 weeks of treatment in patients with sGERD | Daily diary cards completed by the patient |
| Measure | Description | Time Frame |
|---|---|---|
| To demonstrate a difference between esomeprazole 20 mg once daily and placebo qd in the resolution and relief of upper abdominal pain after 1, 2, and 4 weeks of treatment in patients with sGERD | Daily diary cards completed by the patient | |
| To demonstrate a difference in percentage of days with, days to resolution of, and severity of upper abdominal pain through 4 weeks of treatment between esomeprazole 20 mg once daily and placebo qd in patients with sGERD |
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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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| Matching placebo |
| Drug |
Oral Once Daily |
|
| Percentage of days without upper abdominal pain over the 4-week treatment period |
| To assess the safety and tolerability of esomeprazole 20 mg qd through 4 weeks of treatment. | Mean severity of the patient's upper abdominal pain over the last 4 weeks. |
| 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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