A Randomized, Open-Label Study to Evaluate the Pharmacokinetics of Single Oral Doses of Esomeprazole Magnesium in Pediatric Patients 1 to 11 Years-Old Inclusive With Endoscopically-Proven Gastroesophageal Reflux Disease (GERD)
Phase of Trial: Phase I
Latest Information Update: 24 Sep 2014
At a glance
- Drugs Esomeprazole (Primary)
- Indications Gastro-oesophageal reflux
- Focus Pharmacokinetics
- Sponsors AstraZeneca
- 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.
- 17 Jun 2008 New trial record.