NCT03118778

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90,895

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 18, 2017

Completed
10 days until next milestone

Study Start

First participant enrolled

April 28, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2017

Completed
Last Updated

July 12, 2018

Status Verified

June 1, 2018

Enrollment Period

2 months

First QC Date

April 13, 2017

Last Update Submit

July 11, 2018

Conditions

Gastrointestinal Disease

Keywords

Stress Ulcer Prevention

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • Patients without data of treatment information.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Beijing, 100013, China

Location

Related Links

MeSH Terms

Conditions

Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2017

First Posted

April 18, 2017

Study Start

April 28, 2017

Primary Completion

July 10, 2017

Study Completion

July 10, 2017

Last Updated

July 12, 2018

Record last verified: 2018-06

Locations

CN(1)