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)

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)

Completed
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
  • Most Recent Events

    • 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.
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