- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03118778
Proton Pump Inhibitor (PPI) Inappropriate Use and Economic Burden in Chinese Population (ECHO)
July 11, 2018 updated by: AstraZeneca
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.
Study Overview
Status
Completed
Conditions
Detailed Description
Study primary objective is to identify the inappropriate use of PPI (overall, outpatient & inpatient).
Study Type
Observational
Enrollment (Actual)
90895
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Beijing, China, 100013
- Research Site
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
• Patients without data of treatment information.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
2015.01-2015.12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 28, 2017
Primary Completion (Actual)
July 10, 2017
Study Completion (Actual)
July 10, 2017
Study Registration Dates
First Submitted
April 13, 2017
First Submitted That Met QC Criteria
April 13, 2017
First Posted (Actual)
April 18, 2017
Study Record Updates
Last Update Posted (Actual)
July 12, 2018
Last Update Submitted That Met QC Criteria
July 11, 2018
Last Verified
June 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- D9612R00010
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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