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.
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
- 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.