NCT00868296

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer · Industry
• Sex: All
• Age: 1 Day – 12 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Gastroesophageal Reflux

Interventions

Type	Name	Description
DRUG	pantoprazole

Timeline

• Start date: 2006-03-01
• Primary completion: 2008-03-01
• Completion: 2008-03-01
• First posted: 2009-03-24
• Last updated: 2010-05-04
• Results posted: 2010-01-07

Locations

71 sites across 11 countries: United States, Australia, Belgium, Canada, France, Germany, Italy, Netherlands, Poland, South Africa, Switzerland