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

NCT01338363 | Completed

• 1 other identifier: D9612N00016
• Study Type: observational
• Target: 23,470
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is

1. 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. 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

Hospitalized Cases of Angioneurotic Oedema; Pneumonia; Gastroenteritis; Failure to Thrive; Seizures; Acute Interstitial Nephritis and Thrombocytopenia

Keywords

acid suppressing drugs; pharmacoepidemiology; children

Outcome Measures

Primary Outcomes (2)

• Drug utilization: Description of patient characteristics and drug usage

  Study period 3 years

• 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

Study Arms (3)

All first time users of esomeprazole

All first time users of other PPIs

All first time users of H2-receptor antagonists

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age 0-18 years
• Newly dispensed esomeprazole, other proton pump inhibitors or H2-receptor antagonists

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead
• PHARMO Institute for Drug Outcome Research: collaborator

Study Sites (1)

Reserach Site

Utrecht, Netherlands

Location

Related Publications (2)

• 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.

  PMID: 29149805 DERIVED

• 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.

  PMID: 28562108 DERIVED

Related Links

• D9612N00016 Children Study report synopsis Final redacted

MeSH Terms

Conditions

Pneumonia; Gastroenteritis; Failure to Thrive; Seizures; Acute Tubulointerstitial Nephritis; Thrombocytopenia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Nervous System Diseases; Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia

Study Officials

• Ron M.C. Herings, PhD

  PHARMO Institute for Drug Outcome Research, Utrecht, The Netherlands

  PRINCIPAL INVESTIGATOR

• Leanne M.A. Houweling, MSc

  PHARMO Institute for Drug Outcome Research, Utrecht, The Netherlands

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2011
• First Posted: April 19, 2011
• Study Start: May 1, 2011
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: August 10, 2016

Record last verified: 2016-08

Locations

NL (1)