Gastroesophageal Reflux Disease (GERD) Clinical Trial
Official title:
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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