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This study is a phase III, multi-centre, randomized, double-blind study to assess the safety and tolerability of once daily treatment with esomeprazole 20 or 40 mg in pediatric and adolescent patients 12 to 17 years of age, inclusive, with clinically diagnosed GERD. The treatment period will be up to 8 weeks.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esomeprazole (Nexium) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate safety & how tolerable a once daily treatment with esomeprazole is in pediatric & adolescent patients | ||
| 12 to 17 years of age, inclusive, with clinically diagnosed Gastroesophageal Reflux Disease (G |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the clinical outcome of once daily treatment with esomeprazole in relieving gastroesophageal reflux disease (GERD)-associated signs & symptoms in pediatric & adolescent patients 12 to 17 years of age | ||
| - Assessment of changes from baseline in daily patient symptom assessment as reported by the patient. |
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Inclusion Criteria:
Exclusion Criteria:
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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 | Phoenix | Arizona | United States | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19922626 | Derived | Gunasekaran T, Tolia V, Colletti RB, Gold BD, Traxler B, Illueca M, Crawley JA. Effects of esomeprazole treatment for gastroesophageal reflux disease on quality of life in 12- to 17-year-old adolescents: an international health outcomes study. BMC Gastroenterol. 2009 Nov 18;9:84. doi: 10.1186/1471-230X-9-84. |
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| - Assessment of changes from baseline in Physician Global Assessment. |
| Little Rock |
| Arkansas |
| United States |
| Research Site | Wilmington | Delaware | United States |
| Research Site | Orlando | Florida | United States |
| Research Site | Atlanta | Georgia | United States |
| Research Site | Park Ridge | Illinois | United States |
| Research Site | Indianapolis | Indiana | United States |
| Research Site | Iowa City | Iowa | United States |
| Research Site | Shreveport | Louisiana | United States |
| Research Site | Boston | Massachusetts | United States |
| Research Site | Waltham | Massachusetts | United States |
| Research Site | Detroit | Michigan | United States |
| Research Site | Plymouth | Minnesota | United States |
| Research Site | Saint Paul | Minnesota | United States |
| Research Site | Jackson | Mississippi | United States |
| Research Site | Binghamton | New York | United States |
| Research Site | Brooklyn | New York | United States |
| Research Site | Buffalo | New York | United States |
| Research Site | Johnson City | New York | United States |
| Research Site | New Hyde Park | New York | United States |
| Research Site | The Bronx | New York | United States |
| Research Site | Winston-Salem | North Carolina | United States |
| Research Site | Cleveland | Ohio | United States |
| Research Site | Dayton | Ohio | United States |
| Research Site | Philadelphia | Pennsylvania | United States |
| Research Site | Chattanooga | Tennessee | United States |
| Research Site | Burlington | Vermont | United States |
| Research Site | Norfolk | Virginia | United States |
| Research Site | Mount Pearl | Newfoundland and Labrador | Canada |
| Research Site | Halifax | Nova Scotia | Canada |
| Research Site | Greater Sudbury | Ontario | Canada |
| Research Site | Hamilton | Ontario | Canada |
| Research Site | Oakville | Ontario | Canada |
| Research Site | Scarborough Village | Ontario | Canada |
| Research Site | Parkdale | Prince Edward Island | Canada |
| Research Site | Lille | France |
| Research Site | Paris | France |
| Research Site | Tours | France |
| Research Site | Genova | GE | Italy |
| Research Site | Roma | Roma | Italy |
| 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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