Efficacy and Safety of Esomeprazole Once Daily for the Treatment of GERD in Neonatal Patients
Status and phase
Completed
Phase 3
Conditions
GERD
Treatments
Drug: Esomeprazole
Details and patient eligibility
About
The purpose of this study is to assess the difference between esomeprazole and placebo in the treatment of signs and symptoms as observed by 8-hour video and cardiorespiratory monitoring in neonatal patients.
Enrollment
32 patients
Sex
All
Ages
Under 1 month old
Volunteers
No Healthy Volunteers
Inclusion criteria
- Full-term or gestational age >/= 28 to 44 weeks
- In-patient in Neonatal Intensive Care Unit, special care nursery, or equivalent
- Patient must be on a stable mode of feeding or with minimal variations for at least 2 days prior to randomization
Exclusion criteria
- Patients with a need for resectional or reconstructive surgery of the gastrointestinal tract
- Patients with any condition that may require surgery during the course of the study
- Patients with acute respiratory distress within 72 hours prior to enrollment
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Double Blind
Trial contacts and locations
3
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Data sourced from clinicaltrials.gov
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