Status:
COMPLETED
A Pharmacokinetics, Pharmacodynamics and Safety Study of Rabeprazole in New Born Infants With Gastroesophageal Reflux Disease (GERD)
Lead Sponsor:
Janssen Research & Development, LLC
Collaborating Sponsors:
Eisai Inc.
Conditions:
Gastroesophageal Reflux
Eligibility:
All Genders
Up to 44 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the pharmacokinetics, pharmacodynamics, and the safety of rabeprazole sodium for the treatment of gastroesophageal reflux disease (GERD) in newborns and pre-te...
Detailed Description
This is a multi-center Phase I study in newborns and pre-term infants (less than 44 weeks at the time of the first dose). The drug being studied is rabeprazole sodium, the active pharmaceutical ingred...
Eligibility Criteria
Inclusion
- Patients must need a feeding tube in place for enteral alimentation (complete or partial) and be in a neonatal intensive care unit or step down unit
- Patients participating in the pHmetry assessment must be in need of this assessment
- New born, neonate or pre-term infants less than 44 weeks with a minimum weight of 0.8 kg and with a presumptive diagnosis of GERD
- Patients who have been treated with, or are currently receiving a proton pump inhibitor (PPI), H2-blockers or antacids
- Patients should be generally healthy, other than for the presence of GERD.
Exclusion
- A history of or current clinically significant medical illness (excluding GERD, asthma, reactive airway disease or cystic fibrosis-dependant GERD)
- Continuous drip tube feeding with formula or breast milk
- Patients whose mothers are taking PPIs and who are pumping breast milk to be fed to their infants
- Continuous positive airway pressure (CPAP) delivered via nasal prong or oral mask
- Serum concentrations of hepatic transaminases \> 3-fold higher than the upper limit of normal for age creatinine values = 106 micromoles/L
- Clinically relevant abnormal laboratory values
- Treatment with full therapeutic doses of sucralfate or any medication that affects gastrointestinal motility such as baclofen, erythromycin, metoclopramide, cisapride, or domperidone
- A history of allergy or sensitivity to PPIs or to their inactive ingredients
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT00855361
Start Date
July 1 2009
End Date
December 1 2011
Last Update
April 29 2013
Active Locations (19)
Enter a location and click search to find clinical trials sorted by distance.
1
Orange, California, United States
2
Washington D.C., District of Columbia, United States
3
Augusta, Georgia, United States
4
Maywood, Illinois, United States