Drug Utilization and Safety Events Among Children Using Esomeprazole, Other Proton Pump Inhibitors or H2-receptor Antagonists

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

23470 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-05-31

Study Completion Date

2015-08-31

Brief Summary

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The purpose of this study is

1. To describe patient characteristics and drug usage among children that are prescribed esomeprazole for the first time and to compare them with patients who are prescribed other proton pump inhibitors (PPIs) or H2-receptor antagonists for the first time.
2. To ascertain all incident hospitalized cases of angioneurotic oedema, pneumonia, gastroenteritis, failure to thrive, convulsions/seizures, acute interstitial nephritis and thrombocytopenia among new users in the three cohorts of esomeprazole, other PPIs and H2-receptor antagonists.

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Detailed Description

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Time Perspective: Other = Retrospective analysis of prospectively collected data Number of Anticipated Subjects: All subjects dispensed esomeprazole, other PPIs or H2-receptor antagonists for the first time during the study period

Conditions

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Hospitalized Cases of Angioneurotic Oedema Pneumonia Gastroenteritis Failure to Thrive Seizures Acute Interstitial Nephritis and Thrombocytopenia

Study Design

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Observational Model Type

COHORT

Study Groups

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All first time users of esomeprazole

No interventions assigned to this group

All first time users of other PPIs

No interventions assigned to this group

All first time users of H2-receptor antagonists

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Age 0-18 years
* Newly dispensed esomeprazole, other proton pump inhibitors or H2-receptor antagonists

Exclusion Criteria

* Children with less than one year of history in PHARMO RLS before study cohort entry (if a child is \<1 year at cohort entry, history from birth is required)
* Children using more than 1 acid suppressing drug concomitantly at cohort entry

Eligible Sex

ALL

Accepts Healthy Volunteers

No