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NCT01338363 Clinical Trial

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

Pneumonia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01338363
Other study ID # D9612N00016
Secondary ID
Status Completed
Phase N/A
First received April 18, 2011
Last updated August 9, 2016
Start date May 2011
Est. completion date August 2015

Study information
Verified date August 2016
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Sweden: Medical Products Agency
Study type Observational

Clinical Trial 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.

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

Recruitment information / eligibility
Status Completed
Enrollment 23470
Est. completion date August 2015
Est. primary completion date August 2015
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

Locations
Country Name City State
Netherlands Reserach Site Utrecht

Sponsors (2)
Lead Sponsor Collaborator
AstraZeneca PHARMO Institute for Drug Outcome Research

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary Drug utilization: Description of patient characteristics and drug usage Study period 3 years No
Primary 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 Yes
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