Efficacy and Safety of Esomeprazole Once Daily for the Treatment of GERD in Neonatal Patients

• Status: Completed
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: All

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 patients.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Esomeprazole

Criteria

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