Conditions: Gastroesophageal Reflux Disease (GERD)
Keywords: pediatrics neonates
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 98
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: This is an open label, run-in phase. All patients received Esomeprazole. arm 2: This is the double blind withdrawal phase. Patients are randomized to active drug or placebo. arm 3: This is the double blind withdrawal phase. Patients are randomized to active drug or placebo.

Interventions: intervention 1: Open Label Run In Esomeprazole intervention 2: Double Blind Esomeprazole intervention 3: Double Blind Placebo
Intervention descriptions: intervention 1: Esomeprazole magnesium in capsules dosing weight-dependent (2.5 mg - 10 mg) intervention 2: Esomeprazole magnesium in capsules dosing weight-dependent (2.5 mg - 10 mg) intervention 3: Double Blind Placebo

Protocol document: