A Pharmacokinetics, Pharmacodynamics and Safety Study of Rabeprazole in New Born Infants With Gastroesophageal Reflux Disease (GERD)

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

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-term infants.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Research & Development, LLC
• Collaborator: Eisai Inc.
• Treatments: Rabeprazole

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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