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

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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Key information

Conditions

Hospitalized Cases of Angioneurotic Oedema Acute Interstitial Nephritis and Thrombocytopenia Acute Tubulointerstitial Nephritis Blood Platelet Disorders Cytopenia Digestive System Diseases Failure to Thrive Gastroenteritis Gastrointestinal Diseases Hematologic Diseases Hemic and Lymphatic Diseases Infections Lung Diseases Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Pneumonia Respiratory Tract Diseases Respiratory Tract Infections Seizures Signs and Symptoms Thrombocytopenia

Sex eligibility

All sexes

Study type

Observational

Primary location

Reserach Site

Utrecht, Netherlands

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Drug utilization: Description of patient characteristics and drug usage

Time frame: 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

Time frame: 18 months

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

PHARMO Institute for Drug Outcome Research

Registry information

Important dates

Study start: 2011
Primary completion: 2015
Study completion: 2015
First posted: Apr 19, 2011
Registry last updated: Aug 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed