At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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.
In Brief
A Phase 4 clinical trial evaluating Esomeprazole (Nexium) for Gastroesophageal Reflux Disease (GERD) and 2 related conditions. Completed, across 36 sites in 4 countries.
Detailed 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.