Efficacy and Safety of Esomeprazole Once Daily for the Treatment of GERD in Neonatal Patients
- Conditions
- GERD
- Registration Number
- NCT00427635
- Lead Sponsor
- AstraZeneca
- 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 patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change From Baseline in Normalized Number of GERD Events Observed From Video and Cardiorespiratory Monitoring Baseline and end of treatment (10-14 days) The number of events are normalized prior to summary to correspond to a complete 8-hour monitoring period. Only patients with data at both baseline and final assessment are included.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Number of Acidic Reflux Episodes Baseline and end of treatment (10-14 days) Number of reflux episodes (pH\<4.0) based on 24-hour impedance monitoring data
Change From Baseline in Number of Weakly Acidic Reflux Episodes Baseline and end of treatment (10-14 days) Number of reflux episodes (pH 4.0-6.9) based on 24-hour impedance monitoring data
Change From Baseline in Number of Non Acidic Reflux Episodes Baseline and end of treatment (10-14 days) Number of reflux episodes (pH\>=7.0) based on 24-hour impedance monitoring data
Change From Baseline in Number of Liquid Acidic Reflux Episodes Baseline and end of treatment (10-14 days) Number of reflux episodes based on 24-hour impedance monitoring data
Change From Baseline in Number of Mixed Gas/Liquid Acidic Reflux Episodes Baseline and end of treatment (10-14 days) Number of reflux episodes based on 24-hour impedance monitoring data
Change From Baseline in Number of Reflux Episodes (Acid or Non-acid) Baseline and end of treatment (10-14 days) Number of reflux episodes based on 24-hour impedance monitoring data
Change From Baseline in Mean Bolus Clearance Time Baseline and end of treatment (10-14 days) Based on 24-hour impedance monitoring data
Change From Baseline in Percentage Time With pH<4.0 Baseline and end of treatment (10-14 days) Percentage time with pH\<4 during 24-hour pH monitoring
Change From Baseline in Percentage Time With pH Within 4.0-6.9 Baseline and end of treatment (10-14 days) Percentage time with pH 4.0-6.9 during 24-hour pH monitoring
Change From Baseline in Normalized Number of GERD Events During Video and Cardiorespiratory Monitoring Associated With Acid Reflux Baseline and end of treatment (10-14 days) Event considered associated with reflux if start time of GERD sign/symptom is within 2 minutes of start time of acid reflux. The number of events are normalized prior to summary to correspond to a complete 8-hour monitoring period. Only patients with data at both baseline and final assessment are included.
Change From Baseline in Mean Acid Clearance Time Baseline and end of treatment (10-14 days) Based on 24-hour impedance monitoring data
Trial Locations
- Locations (1)
Research Site
🇬🇧Sheffield, United Kingdom
Research Site🇬🇧Sheffield, United Kingdom