Status:
COMPLETED
A Study to Evaluate the Effect of Lansoprazole on Hospitalized Neonates With Gastroesophageal Reflux Disease
Lead Sponsor:
Takeda
Conditions:
Gastroesophageal Reflux Disease
Eligibility:
All Genders
1-28 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, multi-center, pharmacokinetic/pharmacodynamic and safety, study in which neonates will be randomized in an open-label fashion to receive 5 days of open-label treatment with either lansopraz...
Eligibility Criteria
Inclusion
- 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
- 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 :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2005
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00174928
Start Date
May 1 2005
End Date
August 1 2005
Last Update
July 22 2010
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