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To look at the safety and improvement in symptoms of a once a day dosing of esomeprazole in children 1 to 11 years old with inflammation of their esophagus or food pipe ("esophagitis") caused by gastroesophageal reflux disease (GERD) and diagnosed by endoscopy.
To verify the healing of the esophageal inflammation if the endoscopy reveals cuts in the lining of the food pipe.
To collect information that will describe the psychological, social, and economic effects on the primary caregiver of raising children ages 1 to 5 years old with GERD.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esomeprazole (Nexium) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| The primary objective of the study is to evaluate the safety of once daily treatment with esomeprazole in relieving GERD-associated symptoms in pediatric patients 1 to 11 years of age, inclusive. | ||
| The primary outcome variables include assessment of changes from baseline in medical history, physical examination, clinical laboratory evaluations, and adverse events. |
| Measure | Description | Time Frame |
|---|---|---|
| The secondary objective of the study is to evaluate the clinical outcome of once daily treatment with esomeprazole in relieving GERD-associated signs and symptoms in pediatric patients 1 to 11 years of age, inclusive. | ||
| The secondary objectives include: |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Mobile | Alabama | United States | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26422096 | Derived | Tolia V, Gilger MA, Barker PN, Illueca M. Healing of Erosive Esophagitis and Improvement of Symptoms of Gastroesophageal Reflux Disease After Esomeprazole Treatment in Children 12 to 36 Months Old. J Pediatr Gastroenterol Nutr. 2015 Jul;60 Suppl 1:S31-6. doi: 10.1097/MPG.0b013e3181ddcf11. | |
| 26422095 | Derived |
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| - Assessment of changes from baseline in daily patient symptom assessment as reported by parent/guardian. |
| - Assessment of changes from baseline in Physician's Global Assessment |
| - Assessment of endoscopic healing of erosive esophagitis |
| Phoenix |
| Arizona |
| United States |
| Research Site | Wilmington | Delaware | United States |
| Research Site | Orlando | Florida | United States |
| Research Site | Chicago | Illinois | United States |
| Research Site | Park Ridge | Illinois | United States |
| Research Site | Boston | Massachusetts | United States |
| Research Site | Detroit | Michigan | United States |
| Research Site | Troy | Michigan | United States |
| Research Site | Jackson | Mississippi | United States |
| Research Site | St Louis | Missouri | United States |
| Research Site | Omaha | Nebraska | United States |
| Research Site | Morristown | New Jersey | United States |
| Research Site | Brooklyn | New York | United States |
| Research Site | Buffalo | New York | United States |
| Research Site | West Islip | New York | United States |
| Research Site | Columbus | Ohio | United States |
| Research Site | Hershey | Pennsylvania | United States |
| Research Site | Philadelphia | Pennsylvania | United States |
| Research Site | Chattanooga | Tennessee | United States |
| Research Site | Dallas | Texas | United States |
| Research Site | Houston | Texas | United States |
| Research Site | Burlington | Vermont | United States |
| Research Site | Norfolk | Virginia | United States |
| Research Site | Brussels | Belgium |
| Research Site | Brussels (Jette) | Belgium |
| Research Site | Brussels (Laeken) | Belgium |
| Research Site | Brussels (Woluwé-St-Lambert) | Belgium |
| Research Site | Leuven | Belgium |
| Research Site | Lille | France |
| Research Site | Paris | France |
| Research Site | Tours | France |
| Research Site | Genova | GE | Italy |
| Research Site | Parma | PR | Italy |
| Research Site | Roma | RM | Italy |
| Research Site | Naples | Italy |
| Tolia V, Youssef NN, Gilger MA, Traxler B, Illueca M. Esomeprazole for the Treatment of Erosive Esophagitis in Children: An International, Multicenter, Randomized, Parallel-Group, Double-Blind (for Dose) Study. J Pediatr Gastroenterol Nutr. 2015 Jul;60 Suppl 1:S24-30. doi: 10.1097/01.mpg.0000469419.29000.94. |
| 26121348 | Derived | Tolia V, Gilger MA, Barker PN, Illueca M. Healing of Erosive Esophagitis and Improvement of Symptoms of Gastroesophageal Reflux Disease After Esomeprazole Treatment in Children 12 to 36 Months Old. J Pediatr Gastroenterol Nutr. 2015 Jul;60 Suppl 1:S31-6. doi: 10.1097/MPG.0b013e3181ddcf11. |
| 26121347 | Derived | Tolia V, Youssef NN, Gilger MA, Traxler B, Illueca M. Esomeprazole for the Treatment of Erosive Esophagitis in Children: An International, Multicenter, Randomized, Parallel-Group, Double-Blind (for Dose) Study. J Pediatr Gastroenterol Nutr. 2015 Jul;60 Suppl 1:S24-30. doi: 10.1097/01.mpg.0000469419.29000.94. |
| 20706150 | Derived | Tolia V, Gilger MA, Barker PN, Illueca M. Healing of erosive esophagitis and improvement of symptoms of gastroesophageal reflux disease after esomeprazole treatment in children 12 to 36 months old. J Pediatr Gastroenterol Nutr. 2010 Nov;51(5):593-8. doi: 10.1097/MPG.0b013e3181ddcf11. |
| 20540767 | Derived | Tolia V, Youssef NN, Gilger MA, Traxler B, Illueca M. Esomeprazole for the treatment of erosive esophagitis in children: an international, multicenter, randomized, parallel-group, double-blind (for dose) study. BMC Pediatr. 2010 Jun 11;10:41. doi: 10.1186/1471-2431-10-41. |
| 18493207 | Derived | Gilger MA, Tolia V, Vandenplas Y, Youssef NN, Traxler B, Illueca M. Safety and tolerability of esomeprazole in children with gastroesophageal reflux disease. J Pediatr Gastroenterol Nutr. 2008 May;46(5):524-33. doi: 10.1097/MPG.0b013e318176b2cb. |
| 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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