Esomeprazole for Treatment of GERD in Pediatric Patients

Inclusion Criteria:

• Patients' parents/guardians must provide written informed consent prior to theexecution of any study-related procedures.

• Patients who are able to comprehend their involvement in a clinical study, includingrisks and benefits, (typically ≥6 years of age) must have assent documented by studypersonnel prior to any study-related procedures.

• Patients must be diagnosed with endoscopically proven GERD by the investigator duringthe screening period or have a previous (within 2 weeks prior to Visit 1) diagnosis oferosive esophagitis by endoscopy and are candidates for PPI therapy.

Exclusion Criteria:

• Patients who have used a proton pump inhibitor within 14 days prior to randomization,including over-the-counter omeprazole.

• Patients who have used any prescription or over-the-counter (OTC) treatment (otherthan proton pump inhibitors) for symptoms of GERD, such as histamine 2 receptorantagonists or prokinetics, within 72 hours prior to randomization.

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