Trial Profile
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)
Status:
Completed
Phase of Trial:
Phase I
Latest Information Update: 03 Nov 2015
Price :
$35
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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.