Proton Pump Inhibitor (PPI) Inappropriate Use and Economi... | NCT03118778

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

NCT03118778

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Jul 12, 2018Actual

Enrollment

90,895Actual

Phase

Not provided

Conditions

Gastrointestinal Disease

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 28, 2017Actual

Primary Completion Date

Jul 10, 2017Actual

Completion Date

Jul 10, 2017Actual

First Submitted Date

Apr 13, 2017

First Submission Date that Met QC Criteria

Apr 13, 2017

First Posted Date

Apr 18, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 11, 2018

Last Update Posted Date

Jul 12, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

90,895Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder 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.

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Beijing		100013	China

Label	URL
D9612R00010\_CSR-Synopsis\_V 1.0-20180629	View source

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005767	Gastrointestinal Diseases

Ancestor Terms

ID	Term
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided