At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 127 enrolled
Drug / intervention
rabeprazole +1 moredrug
Likely dose
rabeprazole 0.5mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·interventional·Posted Nov 10, 2008·Updated Jan 24, 2013
In Brief
A Phase 3 clinical trial evaluating rabeprazole for Gastroesophageal Reflux Disease (GERD). Completed, enrolled 127 participants.
Detailed Summary
The purpose of the study is to access the effectiveness and safety of oral rabeprazole in the treatment of acid-related disorders in pediatric patients, focusing specifically on the manifestation of GERD (symptomatic and erosive types).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastroesophageal Reflux Disease (GERD)
Countries--
CollaboratorsEisai Inc.
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 2008
Enrollment StartJan 2009
Primary CompletionJan 2011
TodayJul 2026
First PostedNov 10, 2008
Enrollment StartJan 1, 2009
Primary CompletionJan 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 17.6 years ago
Interventions
rabeprazoledrug
0.5mg/kg once daily for 12 weeks plus option for F/u another 24 weeks
rabeprazoledrug
1.0 mg/kg once daily for 12 weeks plus option for F/u another 24 weeks