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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.
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.
Age
1 - 11 years
Sex
ALL
Healthy Volunteers
No
Research Site
Mobile, Alabama, United States
Research Site
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
Start Date
October 1, 2004
Completion Date
October 1, 2005
Last Updated
November 19, 2010
100
Estimated participants
Esomeprazole (Nexium)
DRUG
Lead Sponsor
AstraZeneca
NCT07344935
NCT07179250
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05587309