Study identifier:D9612N00016
ClinicalTrials.gov identifier:NCT01338363
EudraCT identifier:N/A
CTIS identifier:N/A
Drug utilization and safety events among children using esomeprazole, other proton pump inhibitors or H2-receptor antagonists
Hospitalized cases of angioneurotic oedema, pneumonia
N/A
No
-
All
23470
Observational
N/A
Allocation: -
Endpoint Classification: -
Intervention Model: -
Masking: -
Primary Purpose: -
Verified 01 Aug 2016 by AstraZeneca
AstraZeneca
PHARMO Institute for Drug Outcome Research
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.
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
Location
Location
Utrecht, Netherlands
Arms | Assigned Interventions |
---|---|
All first time users of esomeprazole | - |
All first time users of other PPIs | - |
All first time users of H2-receptor antagonists | - |
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