A Study to Evaluate the Effect of Lansoprazole on Infants With Gastroesophageal Reflux Disease.

• Status: Completed
• Trial end date: 2005-07-01
• 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:

• Hospitalized or outpatient male or female, term or post-term infants beyond the neonatal period (>28 days) but less than 12 months of age, OR a preterm infant with a corrected age of at least 44 weeks but less than 12 months on Dosing Day 1.

• Clinically-evident Gastroesophageal Reflux Disease (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