NCT00300755

Study Evaluating Pantoprazole in Children With Gastroesophageal Reflux Disease (GERD)

A Multicenter, Randomized, Double-Blind Study of the Clinical Outcomes, Safety and Tolerability of Multiple Doses of Pantoprazole Sodium Enteric-Coated Spheroids in Children Ages 1 to 5 With Endoscopically Proven Symptomatic Gastroesophageal Reflux Disease (GERD)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer · Industry
• Sex: All
• Age: 1 Year – 5 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the clinical outcomes of treatment with oral pantoprazole in children 1 through 5 years of age with endoscopically proven symptomatic GERD.

Conditions

• Gastroesophageal Reflux

Interventions

Type	Name	Description
DRUG	pantoprazole sodium enteric-coated spheroid	pediatric spheroids taken daily x 8 weeks

Timeline

• Start date: 2006-05-01
• Primary completion: 2008-04-01
• Completion: 2008-04-01
• First posted: 2006-03-09
• Last updated: 2010-05-19
• Results posted: 2010-05-19

Locations

43 sites across 2 countries: United States, Canada