Overview

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