A Multi-Center, Double-Blind, Parallel-Group Study to Evaluate Short-Term Safety and Efficacy and Long-Term Maintenance of Two Dose Levels of Rabeprazole Sodium Delayed-Release Pediatric Bead Formulation in 1- to 11-Year Old Pediatric Subjects With Endoscopically Proven GERD.

Trial Profile

A Multi-Center, Double-Blind, Parallel-Group Study to Evaluate Short-Term Safety and Efficacy and Long-Term Maintenance of Two Dose Levels of Rabeprazole Sodium Delayed-Release Pediatric Bead Formulation in 1- to 11-Year Old Pediatric Subjects With Endoscopically Proven GERD.

Completed
Phase of Trial: Phase III

Latest Information Update: 30 Sep 2017

At a glance

  • Drugs Rabeprazole (Primary)
  • Indications Gastro-oesophageal reflux
  • Focus Adverse reactions; Pharmacogenomic; Registrational; Therapeutic Use
  • Most Recent Events

    • 26 Mar 2013 Results from the 24-week maintenance phase of the trial have been reported in an Eisai media release.
    • 26 Mar 2013 The US FDA has approved rabeprazole extended-release [ACIPHEX Sprinkle 5 and 10mg capsules; Eisai] for use in children aged 1-11 years with gastro-oesophageal reflux in Mar 2013. The approval was supported by results from this trial.
    • 28 Jun 2012 Additional locations added as reported by European Clinical Trials Database.
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