Status:
COMPLETED
Efficacy and Safety of Esomeprazole Once Daily for the Treatment of GERD in Neonatal Patients
Lead Sponsor:
AstraZeneca
Conditions:
GERD
Eligibility:
All Genders
Up to 1 years
Phase:
PHASE3
Brief Summary
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 p...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00427635
Start Date
October 1 2006
End Date
April 1 2009
Last Update
December 20 2010
Active Locations (3)
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1
Research Site
North Adelaide, Australia
2
Research Site
Aachen, Germany
3
Research Site
Sheffield, United Kingdom