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

NCT01338363 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 23470

Last updated 2016-08-10

No results posted yet for this study

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.

Conditions

Sponsors & Collaborators

  • PHARMO Institute for Drug Outcome Research

    collaborator UNKNOWN

  • AstraZeneca

    lead INDUSTRY

Principal Investigators

  • Ron M.C. Herings, PhD · PHARMO Institute for Drug Outcome Research, Utrecht, The Netherlands

  • Leanne M.A. Houweling, MSc · PHARMO Institute for Drug Outcome Research, Utrecht, The Netherlands

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2015-08-31
Completion
2015-08-31

Countries

  • Netherlands

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01338363 on ClinicalTrials.gov