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The purpose of this study is to evaluate whether there is a difference in proportion of patients with resolution of heartburn and other symptoms related to gastroesophageal reflux disease (GERD) after four weeks of treatment with esomeprazole (NEXIUM®) in those subjects with Erosive Esophagitis (EE) and those without EE.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esomeprazole | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| The outcome variable will be the percentage of patients with heartburn resolution stratified by the presence or absence of EE |
| Measure | Description | Time Frame |
|---|---|---|
| The outcome variables will be resolution of acid regurgitation, dysphagia, and epigastric pain symptoms after 2 and 4 weeks of treatment. | ||
| The outcome variable will be the resolution of heartburn after 2 weeks of treatment. |
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Inclusion Criteria:
Exclusion Criteria:
Generalized bleeding disorders resulting from hemorrhagic diathesis (such as abnormalities in clotting factors or platelets).
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| Name | Affiliation | Role |
|---|---|---|
| AstraZeneca Nexium Medical Sciences Director, MD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Alabaster | Alabama | United States | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19601705 | Derived | Orlando RC, Monyak JT, Silberg DG. Predictors of heartburn resolution and erosive esophagitis in patients with GERD. Curr Med Res Opin. 2009 Sep;25(9):2091-102. doi: 10.1185/03007990903080931. |
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| The outcome variables will be the presence or absence of EE at baseline and the resolution of heartburn at the end of the 4-week treatment period. |
| The outcome variable used for this objective will be the percentage of endoscoped patients with EE (LA Classification Grades A-D) at baseline. |
| Safety variables that will be measured and tabulated include adverse events, laboratory evaluations, physical exams, and vital signs. |
| Mobile |
| Alabama |
| United States |
| Research Site | Tucson | Arizona | United States |
| Research Site | North Little Rock | Arkansas | United States |
| Research Site | Anaheim | California | United States |
| Research Site | Orange | California | United States |
| Research Site | Torrance | California | United States |
| Research Site | Miami | Florida | United States |
| Research Site | Ocoee | Florida | United States |
| Research Site | Tampa | Florida | United States |
| Research Site | Zephyrhills | Florida | United States |
| Research Site | Arlington Heights | Illinois | United States |
| Research Site | New Orleans | Louisiana | United States |
| Research Site | Shreveport | Louisiana | United States |
| Research Site | Hollywood | Maryland | United States |
| Research Site | Elkin | North Carolina | United States |
| Research Site | Oklahoma City | Oklahoma | United States |
| Research Site | Chattanooga | Tennessee | United States |
| Research Site | Knoxville | Tennessee | United States |
| Research Site | Austin | Texas | United States |
| Research Site | Houston | Texas | United States |
| Research Site | Ogden | Utah | United States |
| Research Site | Salt Lake City | Utah | United States |
| Research Site | Christiansburg | Virginia | United States |
| Research Site | Norfolk | Virginia | United States |
| 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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