Study Evaluating Pantoprazole in Neonates and Preterm Infants With GERD

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether or not consistent drug levels can be achieved in infants with presumed Gastroesophageal Reflux Disease.

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

Details

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

Criteria

Inclusion Criteria:

• Hospitalized patients

• Presumed diagnosis of GERD

• Term or post-term infants within the neonatal period less than 28 days or preterm infants with a corrected gestational age of less than 44 weeks

Exclusion Criteria:

• cardiovascular instability

• clinically significant laboratory abnormalities

• use of warfarin, carbamazepine, phenytoin, or rifampin