Hospitalized Cases of Angioneurotic OedemaNCT01338363
Drug Utilization and Safety Events Among Children Using Esomeprazole, Other Proton Pump Inhibitors or H2-receptor Antagonists
An observational study of Hospitalized Cases of Angioneurotic Oedema and Pneumonia, run by AstraZeneca at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hospitalized Cases of Angioneurotic Oedema, Pneumonia, Gastroenteritis
- How many people
- 23,470 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2011to Aug 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Age 0-18 years
- Newly dispensed esomeprazole, other proton pump inhibitors or H2-receptor antagonists
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is
- 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.
- 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.
Read the 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
- Keywords
- acid suppressing drugs, pharmacoepidemiology, children
- Medical subject headings
- Pneumonia, Gastroenteritis, Failure to Thrive, Seizures, Acute Tubulointerstitial Nephritis, Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| All first time users of esomeprazole | Not described | |
| All first time users of other PPIs | Not described | |
| All first time users of H2-receptor antagonists | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drug utilization: Description of patient characteristics and drug usage
Measured: 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
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2011 (estimated)
- Study startMay 2011
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hospitalized Cases of Angioneurotic OedemaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Enrolment
- 23,470 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PHARMO Institute for Drug Outcome Research
- Responsible party
- Sponsor
- Investigators
- Ron M.C. Herings, PhD, Principal investigator, PHARMO Institute for Drug Outcome Research, Utrecht, The NetherlandsLeanne M.A. Houweling, MSc, Principal investigator, PHARMO Institute for Drug Outcome Research, Utrecht, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01338363
- Sponsor's protocol ID
- D9612N00016
- Status last verified
- Aug 2016
- First submitted
- 18 Apr 2011
- Last updated
- 10 Aug 2016
- Results posted
- No
Publications
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.
PubMed 29149805Ruigomez 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.
PubMed 28562108
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Utilization and Safety Events Among Children Using Esomeprazole, Other Proton Pump Inhibitors or H2-receptor Antagonists
- ClinicalTrials.gov ID
- NCT01338363
- Acronym / sponsor ID
- D9612N00016
- Conditions
- Hospitalized Cases of Angioneurotic Oedema, Pneumonia, Gastroenteritis, Failure to Thrive, Seizures, Acute Interstitial Nephritis and Thrombocytopenia
- Keywords
- acid suppressing drugs, pharmacoepidemiology, children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23,470 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- PHARMO Institute for Drug Outcome Research
- Study start
- May 2011
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 19 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is
- 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.
- 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
Study design
- Observational model
- Cohort
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| All first time users of esomeprazole | – | – |
| All first time users of other PPIs | – | – |
| All first time users of H2-receptor antagonists | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Age 0-18 years
- Newly dispensed esomeprazole, other proton pump inhibitors or H2-receptor antagonists
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Drug utilization: Description of patient characteristics and drug usage
Time frame: 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
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2016.
- Derived from this study: PubMed 29149805Houben 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.
- Derived from this study: PubMed 28562108Ruigomez 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.
- D9612N00016 Children Study report synopsis Final redactedLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ron M.C. Herings, PhD principal investigator
PHARMO Institute for Drug Outcome Research, Utrecht, The Netherlands
Leanne M.A. Houweling, MSc principal investigator
PHARMO Institute for Drug Outcome Research, Utrecht, The Netherlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hospitalized Cases of Angioneurotic Oedema and Pneumonia, run by AstraZeneca at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drug utilization: Description of patient characteristics and drug usage (time frame: Study period 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01338363, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2016.