A Study to Evaluate the Effect of Lansoprazole on Hospitalized Neonates With Gastroesophageal Reflux Disease

• Status: Completed
• Trial end date: 2005-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to understand how quickly lansoprazole, once daily (QD), improves feeding in premature babies or babies less than 28 days of age.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Takeda
• Treatments: Dexlansoprazole; Lansoprazole

Criteria

Inclusion Criteria:

• Neonates in the Neonatal Intensive Care or Special Care Nursery who have been fed orally or by feeding tube.

• Term or post-term infants with a body weight of >800 gms.

• Pre-term infants with a corrected age of less than 44 weeks.

• Clinically-evident GERD (feeding intolerance, regurgitation, wheezing or stridor with feedings)

• At least 7 days post-surgery without anticipated need for surgery during study

• No significant laboratory abnormalities

Exclusion Criteria:

• Unstable, clinically significant disease or abnormality

• Congenital anomaly of the upper gastrointestinal tract

• Clinical evidence of acute sepsis

• Cystic fibrosis

• Medical condition requiring subject to not be fed by mouth/gastric tube