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
Phase of Trial: Phase III
Latest Information Update: 10 Jul 2014
At a glance
- Drugs Esomeprazole (Primary)
- Indications Gastro-oesophageal reflux
- Focus Therapeutic Use
- Sponsors AstraZeneca
- 25 Nov 2009 Results presented at GASTRO 2009.
- 19 Dec 2008 Based on the results of this trial and 2 others, AstraZeneca has submitted a sNDA for the short-term treatment of GERD in infants 0-1 years of age.
- 09 Jul 2008 Actual end date (July 2008) added as reported by ClinicalTrials.gov.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History