At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 58 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 Muliticenter, Open Label Safety Study of 2 Doses of Pantoprazole Sodium Enteric-Coated Spheroid Suspension in Infants Aged Less Than 12 Months With Presumed GERD
Wyeth is now a wholly owned subsidiary of Pfizer·interventional·Posted Mar 24, 2009·Updated May 4, 2010
In Brief
A Phase 3 clinical trial evaluating pantoprazole for Gastroesophageal Reflux. Completed, enrolled 58 participants across 71 sites in 11 countries.
Detailed Summary
The purpose of this study is to provide additional information on safety and tolerability after multiple does of pantoprazole. Only patients who successfully completed the 3001B3-331 study (NCT00362609) or 3001B3-333 study (NCT00259012) are eligible to participate in this study.
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 StartMar 2006
Primary CompletionMar 2008
First PostedMar 2009
TodayJul 2026
First PostedMar 24, 2009
Enrollment StartMar 1, 2006
Primary CompletionMar 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 17.3 years ago
Interventions
pantoprazoledrug