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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01338363

Enrollment

23470

Registered

2011-04-19

Start date

2011-05-31

Completion date

2015-08-31

Last updated

2016-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

acid suppressing drugs, pharmacoepidemiology, children

Brief 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.

Detailed 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

Interventions

None listed

Study design

Observational model

COHORT

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

Measure	Time frame
Drug utilization: Description of patient characteristics and drug usage	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	18 months

Countries

Netherlands

Outcome results