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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)

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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

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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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