CompletedNot Applicable

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

Netherlands23,470 participantsStarted 2011-05

Plain-language summary

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.

Who can participate

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Drug utilization: Description of patient characteristics and drug usage

Timeframe: Study period 3 years

Follow-up of safety outcomes: First occurrence of hospitalized angioneurotic oedema, pneumonia, gastroenteritis, failure to thrive, convulsions/seizures, acute interstitial nephritis and thrombocytopenia

Timeframe: 18 months

Trial details

NCT IDNCT01338363

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2015-08

View on ClinicalTrials.gov More Hospitalized Cases of Angioneurotic Oedema trials