Gastrointestinal DiseaseECHONCT03118778
Proton Pump Inhibitor (PPI) Inappropriate Use and Economic Burden in Chinese Population
An observational study of Gastrointestinal Disease, run by AstraZeneca at 1 site in China.
Trial summary
This is a descriptive retrospective database analysis study in using database. All patients with a physician PPI prescription will be selected to estimate the PPI inappropriate use. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gastrointestinal Disease
- How many people
- 90,895 participants
- Where
- 1 siteChina
- Study dates
- 28 Apr 2017to 10 Jul 2017
- 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: Patients who were prescribed PPIs during Jan. 2015 to Dec. 2015 will be identified and then all their inpatient and outpatient information will be extracted.
Who may be able to join
- All patients in 2015 China Health Insurance Research Association (CHIRA) database.
- Patients had PPI prescription during Jan. 2015 to Dec. 2015 will be selected to estimate the PPI inappropriate use.
Who cannot join
- Patients without data of treatment information.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Proton Pump Inhibitor (PPI) Inappropriate Use and Economic Burden in Chinese Population: A Descriptive Retrospective Observational Study Using Database
This is a descriptive retrospective database analysis study in using database. All patients with a physician PPI prescription will be selected to estimate the PPI inappropriate use.
Read the detailed description
Study primary objective is to identify the inappropriate use of PPI (overall, outpatient \& inpatient).
- Conditions
- Gastrointestinal Disease
- Keywords
- Stress Ulcer Prevention
- Medical subject headings
- Gastrointestinal Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall proportion of patient inappropriate use of PPI
Overall number of patient times/courses with PPI inappropriate use (including non-indication use, over maximum daily dose and over maximum duration) divided by the total number of patient-times/courses with PPI use for both outpatients and inpatients.
Measured: 2015.01-2015.12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study start28 Apr 2017
- Primary completion10 Jul 2017
- Study completion10 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal DiseaseStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 90,895 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03118778
- Sponsor's protocol ID
- D9612R00010
- Acronym
- ECHO
- Status last verified
- Jun 2018
- First submitted
- 13 Apr 2017
- Last updated
- 12 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proton Pump Inhibitor (PPI) Inappropriate Use and Economic Burden in Chinese Population: A Descriptive Retrospective Observational Study Using Database
- ClinicalTrials.gov ID
- NCT03118778
- Acronym / sponsor ID
- ECHO / D9612R00010
- Conditions
- Gastrointestinal Disease
- Keywords
- Stress Ulcer Prevention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90,895 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 28 Apr 2017 (actual)
- Primary completion
- 10 Jul 2017 (actual)
- Study completion
- 10 Jul 2017 (actual)
- First posted
- 18 Apr 2017 (actual)
- 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.
This is a descriptive retrospective database analysis study in using database. All patients with a physician PPI prescription will be selected to estimate the PPI inappropriate use.
Detailed description
Study primary objective is to identify the inappropriate use of PPI (overall, outpatient \& inpatient).
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who were prescribed PPIs during Jan. 2015 to Dec. 2015 will be identified and then all their inpatient and outpatient information will be extracted.
Key inclusion criteria (2 listed)
- All patients in 2015 China Health Insurance Research Association (CHIRA) database.
- Patients had PPI prescription during Jan. 2015 to Dec. 2015 will be selected to estimate the PPI inappropriate use.
Key exclusion criteria (1 listed)
- Patients without data of treatment information.
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
Overall proportion of patient inappropriate use of PPI
Time frame: 2015.01-2015.12
Overall number of patient times/courses with PPI inappropriate use (including non-indication use, over maximum daily dose and over maximum duration) divided by the total number of patient-times/courses with PPI use for both outpatients and inpatients.
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 12 Jul 2018.
- D9612R00010\_CSR-Synopsis\_V 1.0-20180629Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Gastrointestinal Disease, run by AstraZeneca at 1 site in China.
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 1 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 12 Jul 2018. 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 China. 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?
Overall proportion of patient inappropriate use of PPI (time frame: 2015.01-2015.12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jul 2018.