At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Treatment-withdrawal Study to Evaluate the Efficacy and Safety of Esomeprazole for the Treatment of Gastroesophageal Reflux (GERD) in Infants Aged 1 to 11 Months, Inclusive
In Brief
A Phase 3 clinical trial evaluating Open Label Run In Esomeprazole, Double Blind Esomeprazole, and 1 other intervention for Gastroesophageal Reflux Disease (GERD). Completed, enrolled 98 participants across 25 sites in 4 countries.
Detailed 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.
Study Details
Timeline
Interventions
Esomeprazole magnesium in capsules dosing weight-dependent (2.5 mg - 10 mg)
Esomeprazole magnesium in capsules dosing weight-dependent (2.5 mg - 10 mg)
Double Blind Placebo