A Pharmacokinetic, Pharmacodynamic and Short-Term Safety Study of Single and Multiple Day Doses of Rabeprazole Sodium in Neonates and Pre-Term Infants With a Corrected Age of Less Than 44 Weeks With a Presumptive Diagnosis of GERD.

Trial Profile

A Pharmacokinetic, Pharmacodynamic and Short-Term Safety Study of Single and Multiple Day Doses of Rabeprazole Sodium in Neonates and Pre-Term Infants With a Corrected Age of Less Than 44 Weeks With a Presumptive Diagnosis of GERD.

Completed
Phase of Trial: Phase I

Latest Information Update: 26 Jul 2016

At a glance

  • Drugs Rabeprazole (Primary)
  • Indications Gastro-oesophageal reflux
  • Focus Adverse reactions; Pharmacodynamics; Pharmacokinetics
  • Most Recent Events

    • 23 Oct 2012 Planned number of patients changed from 60 to 72 as reported by EudraCT.
    • 26 Mar 2012 Actual patient number 69 added as reported by ClinicalTrials.gov.
    • 26 Mar 2012 Actual end date Dec 2011 added as reported by ClinicalTrials.gov.
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