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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

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.

Efficacy and safety of esomeprazole once daily for the treatment of GERD in neonatal patients

Research Site

A randomized, double-blind, placebo controlled, study to evaluate the efficacy and safety of esomeprazole once daily for the treatment of gastroesophageal reflux disease (GERD) in neonatal patients, including premature and up to 1 month corrected age

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.

Age Continuous

Gender, Male/Female

Change from baseline in normalized number of GERD events observed from video and cardiorespiratory monitoring

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 normalized number of GERD events during video and cardiorespiratory monitoring associated with acid reflux

Number of reflux episodes based on 24-hour impedance monitoring data

Change from baseline in number of reflux episodes  (acid or non-acid)

Number of reflux episodes (pH<4.0) based on 24-hour impedance monitoring data

Change from baseline in number of acidic reflux episodes

Number of reflux episodes (pH 4.0-6.9) based on 24-hour impedance monitoring data

Change from baseline in number of weakly acidic reflux episodes

Number of reflux episodes (pH>=7.0) based on 24-hour impedance monitoring data

Change from baseline in number of non acidic reflux episodes

Change from baseline in number of liquid acidic reflux episodes

Change from baseline in number of mixed gas/liquid acidic reflux episodes

Based on 24-hour impedance monitoring data

Change from baseline in mean bolus clearance time

Change from baseline in mean acid clearance time

Percentage time with pH<4 during 24-hour pH monitoring

Change from baseline in percentage time with pH<4.0

Percentage time with pH 4.0-6.9 during 24-hour pH monitoring

Efficacy and safety of esomeprazole once daily for the treatment of GERD in neonatal patients

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

AstraZeneca Clinical Trial Information

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=439&filename=CSP-D9614C00004.pdf

CSR-D9614C00004.pdf

CSP-D9614C00004.pdf

CSP-D9614C00004.pdf

CSR-D9614C00004.pdf

Trial Results Summaries

Contacts

Contact

Contact Backup

Investigators

Principal Investigator