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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by AstraZeneca
Sponsor:
Collaborator:
PHARMO Institute for Drug Outcome Research
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01338363
First received: April 18, 2011
Last updated: July 17, 2014
Last verified: July 2014
  Purpose

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.

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

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Drug Utilization and Safety Events Among Children Using Esomeprazole, Other Proton Pump Inhibitors or H2-receptor Antagonists

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Drug utilization: Description of patient characteristics and drug usage [ Time Frame: Study period 3 years ] [ Designated as safety issue: No ]
  • Follow-up of safety outcomes: First occurrence of hospitalized angioneurotic oedema, pneumonia, gastroenteritis, failure to thrive, convulsions/seizures, acute interstitial nephritis and thrombocytopenia [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 11000
Study Start Date: May 2011
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
All first time users of esomeprazole
All first time users of other PPIs
All first time users of 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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01338363

Contacts
Contact: Saga Johansson +46 31 7761526 ClinicalTrialTransparency@astrazeneca.com

Locations
Netherlands
Reserach Site Recruiting
Utrecht, Netherlands
Sponsors and Collaborators
AstraZeneca
PHARMO Institute for Drug Outcome Research
Investigators
Principal Investigator: 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
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01338363     History of Changes
Other Study ID Numbers: D9612N00016
Study First Received: April 18, 2011
Last Updated: July 17, 2014
Health Authority: Sweden: Medical Products Agency

Keywords provided by AstraZeneca:
acid suppressing drugs
pharmacoepidemiology
children

Additional relevant MeSH terms:
Failure to Thrive
Angioedema
Gastroenteritis
Nephritis, Interstitial
Thrombocytopenia
Blood Platelet Disorders
Cardiovascular Diseases
Digestive System Diseases
Gastrointestinal Diseases
Hematologic Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Kidney Diseases
Nephritis
Signs and Symptoms
Skin Diseases
Skin Diseases, Vascular
Urologic Diseases
Urticaria
Vascular Diseases
Esomeprazole
Histamine H2 Antagonists
Proton Pump Inhibitors
Anti-Ulcer Agents
Enzyme Inhibitors
Gastrointestinal Agents
Histamine Agents
Histamine Antagonists
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 23, 2014