Clinical trial NCT01338363: Drug Utilization and Safety Events Among Children Using Esomeprazole, Other Proton Pump Inhibitors or H2-receptor Antagonists
Official title: Drug Utilization and Safety Events Among Children Using Esomeprazole, Other Proton Pump Inhibitors or H2-receptor Antagonists
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hospitalized Cases of Angioneurotic Oedema
Pneumonia
Gastroenteritis
Failure to Thrive
Seizures
Acute Interstitial Nephritis and Thrombocytopenia
Keywords: acid suppressing drugs
pharmacoepidemiology
children
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: PHARMO Institute for Drug Outcome Research
First posted: 2011-04-19
Enrollment: 23470
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include all children aged 0 to 18 years receiving a first dispension of acid suppressing drugs recorded in the PHARMO RLS database between September 2008 and October 2011. Subjects will be followed-up for at least 18 month. First review of study outcomes including chart reviews is estimated to start in August 2011.

Brief 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

Eligibility criteria: 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

Primary outcomes:
measure: Drug utilization: Description of patient characteristics and drug usage
timeFrame: Study period 3 years
measure: Follow-up of safety outcomes: First occurrence of hospitalized angioneurotic oedema, pneumonia, gastroenteritis, failure to thrive, convulsions/seizures, acute interstitial nephritis and thrombocytopenia
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: Reserach Site
Study officials:
affiliation: PHARMO Institute for Drug Outcome Research, Utrecht, The Netherlands
name: Ron M.C. Herings, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: PHARMO Institute for Drug Outcome Research, Utrecht, The Netherlands
name: Leanne M.A. Houweling, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Houben E, Johansson S, Nagy P, Penning-van Beest FJA, Kuipers EJ, Herings RMC. Observational cohort study: safety outcomes in children using proton pump inhibitors or histamine-2 receptor antagonists. Curr Med Res Opin. 2018 Apr;34(4):577-583. doi: 10.1080/03007995.2017.1407302. Epub 2017 Nov 24.
citation: Ruigomez A, Kool-Houweling LMA, Garcia Rodriguez LA, Penning-van Beest FJA, Herings RMC. Characteristics of children and adolescents first prescribed proton pump inhibitors or histamine-2-receptor antagonists: an observational cohort study. Curr Med Res Opin. 2017 Dec;33(12):2251-2259. doi: 10.1080/03007995.2017.1336083. Epub 2017 Jun 9.