Safety of Daily Dose Esomeprazole for GERD for Pediatric and Adolescent Patients

Inclusion Criteria:

• Provision of signed written informed consent from the patient's parent/guardian, andassent from the patient prior to conducting of any study-related procedures.

• Patients must be male or female between the age of 12 and 17 years, inclusive.

• Patients must have a clinical diagnosis of GERD made by the investigator based on anyof the following factors: history, physical examination, review of systems, laboratorytest results, or information from diagnostic testing.

Exclusion Criteria:

• Patients who have used a PPI within 14 days prior to randomization, includingover-the-counter Prilosec®.

• Patients who have used any prescription or over-the-counter treatment for symptoms ofgastroesophageal reflux disease (GERD), such as Histamine 2 Receptor Antagonists (H2RA) or prokinetics, within 3 days prior to randomization. Antacids may be used,except for those containing bismuth.

• Patients with a known hypersensitivity, allergy, or intolerance to any component ofesomeprazole or omeprazole.