Esomeprazole for Treatment of GERD in Pediatric Patients
A Phase III, Multicentre, Randomized, Double-blind Parallel-group Study to Evaluate the Safety and Clinical Outcome of Once Daily Esomeprazole for the Treatment of Gastroesophageal Reflux Disease (GERD) in Pediatric Patients 1 to 11 Years of Age, Inclusive.
1 other identifier
interventional
100
4 countries
36
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Oct 2004
Shorter than P25 for phase_4
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 27, 2005
CompletedFirst Posted
Study publicly available on registry
September 29, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2005
CompletedNovember 19, 2010
November 1, 2009
September 27, 2005
November 18, 2010
Conditions
Outcome Measures
Primary Outcomes (2)
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.
Secondary Outcomes (5)
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:
- 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
Interventions
Eligibility Criteria
You may qualify if:
- Patients' parents/guardians must provide written informed consent prior to the execution of any study-related procedures.
- 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.
You may not qualify if:
- Patients who have used a proton pump inhibitor within 14 days prior to randomization, including over-the-counter omeprazole.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (36)
Research Site
Mobile, Alabama, United States
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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
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Brussels (Jette), Belgium
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Brussels (Laeken), Belgium
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Brussels (Woluwé-St-Lambert), Belgium
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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
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Parma, PR, Italy
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Roma, RM, Italy
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Napoli, Italy
Related Publications (7)
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.
PMID: 26422096DERIVEDTolia 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.
PMID: 26422095DERIVEDTolia 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.
PMID: 26121348DERIVEDTolia 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.
PMID: 26121347DERIVEDTolia 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.
PMID: 20706150DERIVEDTolia 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.
PMID: 20540767DERIVEDGilger 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.
PMID: 18493207DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 27, 2005
First Posted
September 29, 2005
Study Start
October 1, 2004
Study Completion
October 1, 2005
Last Updated
November 19, 2010
Record last verified: 2009-11