CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 344 enrolled
Drug / intervention
Rabeprazole sodium 5 mg +2 moredrug
Likely dose
Rabeprazole sodium 5 mgfrom 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.

Search/NCT00992589
NCT00992589Phase 3Completed
CompareCT.gov

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)

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·interventional·Posted Oct 9, 2009·Updated May 22, 2013

In Brief

A Phase 3 clinical trial evaluating Rabeprazole sodium 5 mg, Rabeprazole sodium 10 mg, and 1 other intervention for Gastroesophageal Reflux. Completed, enrolled 344 participants across 81 sites in 10 countries.

Detailed Summary

The purpose of this study is to assess the effectiveness and safety of rabeprazole sodium, an inhibitor of gastric acid secretion of the protein pump inhibitor (PPI) class, compared with placebo in the treatment of gastrointestinal esophageal reflux disease (GERD) in infants 1 to 11 months of age.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastroesophageal Reflux
CountriesAustralia, Belgium, Bulgaria, Denmark, Hungary, Israel, Netherlands, Poland, South Africa, United States
CollaboratorsEisai Inc.

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 9, 2009
Enrollment StartNov 1, 2009
Primary CompletionNov 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 16.7 years ago

Interventions

Rabeprazole sodium 5 mgdrug

Rabeprazole Sodium 5 mg capsules once daily in the morning.

Rabeprazole sodium 10 mgdrug

Rabeprazole Sodium 10 mg capsules once daily in the morning.

Placebodrug

Matching placebo capsules once daily in the morning.