A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Withdrawal Study to Evaluate the Safety and Efficacy of Delayed Release Rabeprazole in 1- to 11-Month-Old Pediatric Subjects With Symptomatic/Gastroesophageal Erosive Reflux Disease (GERD).

Trial Profile

A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Withdrawal Study to Evaluate the Safety and Efficacy of Delayed Release Rabeprazole in 1- to 11-Month-Old Pediatric Subjects With Symptomatic/Gastroesophageal Erosive Reflux Disease (GERD).

Completed
Phase of Trial: Phase III

Latest Information Update: 26 Aug 2014

At a glance

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

    • 17 Mar 2012 EudraCT reports trial status as 'recruiting' in Belgium, actual start date Nov 2009 and planned end date as March 2010.
    • 13 Feb 2012 Actual patients number is 346 as reported by ClinicalTrials.gov.
    • 13 Feb 2012 Actual end date (Nov 2011) added as reported by ClinicalTrials.gov.
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