Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-25 @ 4:58 AM
NCT ID:
NCT00220818
Eligibility Criteria:
Inclusion Criteria:
* 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 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
29 Days
Maximum Age:
364 Days
Study:
NCT00220818
Study Brief:
Protocol Section:
NCT00220818