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
The aim of the study is to compare the safety and efficacy of two doses of Nexium in maintaining healing of erosive esophagitis in patients 1 to 11 years of age.
• Patient must be 1 to 11 years of age
• Patients must have a clinical history of GERD for at least 3 months before the start of study
• For the healing phase: Patients must have confirmed presence of EE at endoscopy performed within one week of the start of the healing phase.
• For the maintenance phase: Patients must have completed the healing phase and have endoscopy-verified healed EE at the 8-week endoscopy visit.
• Patients must weigh ≥ 10 kg.
• Patients may be male or female.
• All postmenarcheal female patients must have a negative pregnancy test (urine) before starting treatment.
• Sexually active patients must be abstinent or maintain effective contraception from informed consent day up to the last day of study intervention.
• Patient's guardian must be capable of giving signed informed consent