Open Label Safety Study of Enteric-Coated Spheroid Suspension in Infants Aged Less Than 12 Months With Presumed Gastroesophageal Reflux Disease (GERD)

Phase 3 Completed 58 enrolled Wyeth is now a wholly owned subsidiary of Pfizer

Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start: 2006-03
Primary completion: 2008-03
Completion: 2008-03

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Pantoprazole	Other / unclassified	—	—

Open Label Safety Study of Enteric-Coated Spheroid Suspension in Infants Aged Less Than 12 Months With Presumed Gastroesophageal Reflux Disease (GERD)

Summary

Timeline

Drugs

Indications