At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 59 enrolled
Drug / intervention
pantoprazoledrug
Likely dose
Not stated in 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 Multicenter, Open-Label, PK, PD and Safety Study of Pantoprazole Delayed-Release Granules Administered as a Suspension in Neonates and Preterm Infants With a Clinical Diagnosis of GERD
Wyeth is now a wholly owned subsidiary of Pfizer·interventional·Posted Aug 10, 2006·Updated May 14, 2010
In Brief
A Phase 3 clinical trial evaluating pantoprazole for Gastroesophageal Reflux. Completed, enrolled 59 participants across 71 sites in 11 countries.
Detailed Summary
The purpose of this study is to determine whether or not consistent drug levels can be achieved in infants with presumed Gastroesophageal Reflux Disease.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastroesophageal Reflux
CountriesAustralia, Belgium, Canada, France, Germany, Italy, Netherlands, Poland, South Africa, Switzerland, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJul 2006
First PostedAug 2006
Primary CompletionDec 2007
TodayJul 2026
First PostedAug 10, 2006
Enrollment StartJul 1, 2006
Primary CompletionDec 1, 2007
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 19.9 years ago
Interventions
pantoprazoledrug