Pneumonia Clinical Trial
Official title:
Drug Utilization and Safety Events Among Children Using Esomeprazole, Other Proton Pump Inhibitors or H2-receptor Antagonists
Verified date | August 2016 |
Source | AstraZeneca |
Contact | n/a |
Is FDA regulated | No |
Health authority | Sweden: Medical Products Agency |
Study type | Observational |
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.
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 |
Observational Model: Cohort
Country | Name | City | State |
---|---|---|---|
Netherlands | Reserach Site | Utrecht |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca | PHARMO Institute for Drug Outcome Research |
Netherlands,
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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