Phase 3/Safety & Efficacy of Esomeprazole in Infants
Status:
Completed
Trial end date:
2008-06-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to look at the improvement of a once a day dose of esomeprazole
for reducing the signs and symptoms of infants with gastroesophageal reflux disease (GERD).
This research study consists of a screening, open-label, and double-blind treatment
withdrawal phase. The screening phase ensures the patient eligibility. No study medication is
dispensed during the screening phase. During the open-label phase, patients are administered
esomeprazole 2.5mg, 5.0mg or 10.0mg based on his/her weight. During the double-blind phase,
the patients are administered either his/her open-label dose or placebo. Double-blind means
neither the physician, parent, or patient will know if patient is taking esomeprazole or
placebo. The patient will have an equal chance of receiving esomeprazole or placebo.