Study Evaluating Pantoprazole Sodium Enteric-Coated Spheroid Suspension In Infants With Presumed GERD

• Status: Completed
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profiles to determine the safety and tolerability of single and multiple doses of pantoprazole in infants aged 1 through 11 months.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Collaborator: Nycomed
• Treatments: Pantoprazole

Criteria

Inclusion Criteria:

• Greater than 44 weeks beyond neonatal period but less than 12 months

• Presumptive diagnosis of GERD

• Weight greater than 2.5 kg but less than 15 kg

Exclusion Criteria:

• History of gastrointestinal (GI) disorders, ie, unrepaired tracheal esophageal fistula, GI malabsorption

• Clinically significant medical or surgical abnormalities