Trials / Completed
CompletedNCT01338363
Drug Utilization and Safety Events Among Children Using Esomeprazole, Other Proton Pump Inhibitors or H2-receptor Antagonists
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 23,470 (actual)
- Sponsor
- AstraZeneca · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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
Conditions
- Hospitalized Cases of Angioneurotic Oedema
- Pneumonia
- Gastroenteritis
- Failure to Thrive
- Seizures
- Acute Interstitial Nephritis and Thrombocytopenia
Timeline
- Start date
- 2011-05-01
- Primary completion
- 2015-08-01
- Completion
- 2015-08-01
- First posted
- 2011-04-19
- Last updated
- 2016-08-10
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT01338363. Inclusion in this directory is not an endorsement.