A Phase III Study to Assess the Efficacy and Safety of NEXIUM for Maintenance of Healing of Erosive Esophagitis in Pediatric Patients 1 to 11 Years of Age

Descripción detallada

Esomeprazole (NEXIUM™) is indicated for the maintenance of healing of endoscopy-verified erosive esophagitis (EE) in children 1 to 11 years of age in a number of countries worldwide, but not in the United States (US). The current study has been designed, in discussions with the Food and Drug Administration (FDA), to further evaluate the safety and efficacy of NEXIUM given as maintenance of healing of EE in children 1 to 11 years of age Safety assessments will include the monitoring of adverse events throughout the study, clinical laboratory testing (including hematology, clinical chemistry, urinalysis), vital signs (including blood pressure and pulse), and physical examination including weight.