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

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ClinicalTrials.gov Identifier: NCT01338363
Recruitment Status : Completed
First Posted : April 19, 2011
Last Update Posted : August 10, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

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

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

Study Design

Study Type : Observational
Actual Enrollment : 23470 participants
Observational Model: Cohort
Official Title: Drug Utilization and Safety Events Among Children Using Esomeprazole, Other Proton Pump Inhibitors or H2-receptor Antagonists
Study Start Date : May 2011
Primary Completion Date : August 2015
Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
All first time users of esomeprazole
All first time users of other PPIs
All first time users of H2-receptor antagonists


Outcome Measures

Primary Outcome Measures :
  1. Drug utilization: Description of patient characteristics and drug usage [ Time Frame: Study period 3 years ]
  2. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01338363


Locations
Netherlands
Reserach Site
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

Additional Information:
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01338363     History of Changes
Other Study ID Numbers: D9612N00016
First Posted: April 19, 2011    Key Record Dates
Last Update Posted: August 10, 2016
Last Verified: August 2016

Keywords provided by AstraZeneca:
acid suppressing drugs
pharmacoepidemiology
children

Additional relevant MeSH terms:
Pneumonia
Seizures
Thrombocytopenia
Gastroenteritis
Nephritis
Failure to Thrive
Angioedema
Nephritis, Interstitial
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Blood Platelet Disorders
Hematologic Diseases
Gastrointestinal Diseases
Digestive System Diseases
Kidney Diseases
Urologic Diseases
Vascular Diseases
Cardiovascular Diseases
Urticaria
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity