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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03118778
Other study ID # D9612R00010
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 28, 2017
Est. completion date July 10, 2017

Study information

Verified date June 2018
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


Description:

Study primary objective is to identify the inappropriate use of PPI (overall, outpatient & inpatient).


Recruitment information / eligibility

Status Completed
Enrollment 90895
Est. completion date July 10, 2017
Est. primary completion date July 10, 2017
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Locations

Country Name City State
China Research Site Beijing

Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 2015.01-2015.12
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