Esomeprazole for Treatment of GERD in Pediatric Patients
NCT ID: NCT00228527
Last Updated: 2010-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
100 participants
INTERVENTIONAL
2004-10-31
2005-10-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Esomeprazole (Nexium)
Eligibility Criteria
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Inclusion Criteria
* Patients who are able to comprehend their involvement in a clinical study, including risks and benefits, (typically ≥6 years of age) must have assent documented by study personnel prior to any study-related procedures.
* Patients must be diagnosed with endoscopically proven GERD by the investigator during the screening period or have a previous (within 2 weeks prior to Visit 1) diagnosis of erosive esophagitis by endoscopy and are candidates for PPI therapy.
Exclusion Criteria
* Patients who have used any prescription or over-the-counter (OTC) treatment (other than proton pump inhibitors) for symptoms of GERD, such as histamine 2 receptor antagonists or prokinetics, within 72 hours prior to randomization.
* Patients with a known hypersensitivity, allergy, or intolerance to any component of esomeprazole or omeprazole.
1 Year
11 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Locations
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Research Site
Mobile, Alabama, United States
Research Site
Phoenix, Arizona, United States
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Wilmington, Delaware, United States
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Orlando, Florida, United States
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Chicago, Illinois, United States
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Park Ridge, Illinois, United States
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Boston, Massachusetts, United States
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Detroit, Michigan, United States
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Troy, Michigan, United States
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Jackson, Mississippi, United States
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St Louis, Missouri, United States
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Omaha, Nebraska, United States
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Morristown, New Jersey, United States
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Brooklyn, New York, United States
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Buffalo, New York, United States
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West Islip, New York, United States
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Columbus, Ohio, United States
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Hershey, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Chattanooga, Tennessee, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Burlington, Vermont, United States
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Norfolk, Virginia, United States
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Brussels, , Belgium
Research Site
Brussels (Jette), , Belgium
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Brussels (Laeken), , Belgium
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Brussels (Woluwé-St-Lambert), , Belgium
Research Site
Leuven, , Belgium
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Lille, , France
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Paris, , France
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Tours, , France
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Genova, GE, Italy
Research Site
Parma, PR, Italy
Research Site
Roma, RM, Italy
Research Site
Napoli, , Italy
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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D9614C00097
Identifier Type: -
Identifier Source: org_study_id