A multicenter, open-Label, PK, PD and safety study of Pantoprazole Delayed-Release Granules Administered as a Suspension in Neonates and Preterm Infants With a Clinical Diagnosis of GERD

Trial Profile

A multicenter, open-Label, PK, PD and safety study of Pantoprazole Delayed-Release Granules Administered as a Suspension in Neonates and Preterm Infants With a Clinical Diagnosis of GERD

Completed
Phase of Trial: Phase III

Latest Information Update: 03 Jul 2012

At a glance

  • Drugs Pantoprazole (Primary)
  • Indications Gastro-oesophageal reflux
  • Focus Pharmacodynamics; Pharmacogenomic; Pharmacokinetics
  • Sponsors Wyeth
  • Most Recent Events

    • 03 Jul 2012 Planned number of patients changed from 56 to 90 as reported by European Clinical Trials Database.
    • 18 May 2010 Actual patient number (59) added as reported by ClinicalTrials.gov.
    • 20 Mar 2010 Results published in the European Journal of Clinical Pharmacology.
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