NCT00468559

Phase 3/Safety & Efficacy of Esomeprazole in Infants

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 1 Month – 11 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Gastroesophageal Reflux Disease (GERD)

Interventions

Type	Name	Description
DRUG	Open Label Run In Esomeprazole	Esomeprazole magnesium in capsules dosing weight-dependent (2.5 mg - 10 mg)
DRUG	Double Blind Esomeprazole	Esomeprazole magnesium in capsules dosing weight-dependent (2.5 mg - 10 mg)
DRUG	Double Blind Placebo	Double Blind Placebo

Timeline

• Start date: 2007-04-01
• Primary completion: 2008-06-01
• Completion: 2008-06-01
• First posted: 2007-05-02
• Last updated: 2014-06-02
• Results posted: 2014-06-02

Locations

25 sites across 4 countries: United States, France, Germany, Poland