Esomeprazole for Treatment of GERD in Pediatric Patients

Launched by ASTRAZENECA · Sep 27, 2005

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Eligibility criteria

• Inclusion Criteria:
• • Patients' parents/guardians must provide written informed consent prior to the execution of any study-related procedures.
• • Patients who are able to comprehend their involvement in a clinical study, including risks and benefits, (typically ≥6 years of age) must have assent documented by study personnel prior to any study-related procedures.
• • Patients must be diagnosed with endoscopically proven GERD by the investigator during the screening period or have a previous (within 2 weeks prior to Visit 1) diagnosis of erosive 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 (other than proton pump inhibitors) for symptoms of GERD, such as histamine 2 receptor antagonists or prokinetics, within 72 hours prior to randomization.
• • Patients with a known hypersensitivity, allergy, or intolerance to any component of esomeprazole or omeprazole.