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

AstraZeneca

Status: Completed

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

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT01338363

D9612N00016

Details and patient eligibility

About

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.

Full description

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

Enrollment: 23,470 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

23,470 participants in 3 patient groups

All first time users of esomeprazole

All first time users of other PPIs

All first time users of H2-receptor antagonists