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Proton Pump Inhibitor (PPI) Inappropriate Use and Economic Burden in Chinese Population (ECHO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03118778
Recruitment Status : Completed
First Posted : April 18, 2017
Last Update Posted : July 12, 2018
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief 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.

Condition or disease
Gastrointestinal Disease

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

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Study Type : Observational
Actual Enrollment : 90895 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Proton Pump Inhibitor (PPI) Inappropriate Use and Economic Burden in Chinese Population: A Descriptive Retrospective Observational Study Using Database
Actual Study Start Date : April 28, 2017
Actual Primary Completion Date : July 10, 2017
Actual Study Completion Date : July 10, 2017



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.


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): NCT03118778


Locations
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China
Research Site
Beijing, China, 100013
Sponsors and Collaborators
AstraZeneca
Additional Information:
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT03118778    
Other Study ID Numbers: D9612R00010
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: July 12, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AstraZeneca:
Stress Ulcer Prevention
Additional relevant MeSH terms:
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Gastrointestinal Diseases
Digestive System Diseases