Gastroesophageal Reflux Disease
Conditions
Keywords
Pediatric GERD, Pediatric Gastroesophageal Reflux Disease, Neonates, lansoprazole
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 lansoprazole pediatric suspension 1.0 mg/kg/day orally or lansoprazole pediatric suspension .5 mg/kg/day orally. On dosing Days 1 and 5, blood samples will be obtained for drug assay. All subjects will be evaluated for inclusion in the pH monitoring portion of the study and will undergo pH monitoring, provided it is clinically indicated, at the discretion of the investigator. Intragastric pH monitoring (up to 24 hours) will be performed at baseline, on dosing Day 1 (or Day 2) and on dosing Day 5 (or Day 6). Intraesophageal pH may be done in addition to intragastric pH at the discretion of the investigator. Subjects will be evaluated for safety, including a follow-up visit on post-dosing Day 14.
Interventions
DRUGLansoprazole
Lansoprazole 0.5 mg/kg/day suspension, orally, once daily for up to 5 days.
Sponsors
Takeda
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Days to 28 Days
Healthy volunteers
No
Inclusion criteria
* 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic Analysis | Day 1 and 5 |
| Mean Intragastric 24 hour pH (subset of six subjects) | Day -1, Day 1 and Day 5 |
Secondary
| Measure | Time frame |
|---|---|
| Gastroesophageal Reflux Disease Symptom Analysis | Days 1-5 |
Outcome results
None listed