Status:
COMPLETED
A Study to Evaluate the Effect of Lansoprazole on Infants With Gastroesophageal Reflux Disease.
Lead Sponsor:
Takeda
Conditions:
Gastroesophageal Reflux Disease
Eligibility:
All Genders
29-364 years
Phase:
PHASE1
Brief 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.
Detailed Description
A Phase 1, multicenter, pharmacokinetic/Pharmacodynamic and safety study in which infants will be randomized in an open-label fashion to receive 5 days of open-label treatment with lansoprazole pediat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2005
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00220818
Start Date
January 1 2005
End Date
July 1 2005
Last Update
July 22 2010
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