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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034905
Receipt No. R000039485
Scientific Title Questionnaire survey on prescription of PPI (proton pump inhibitor) in participants who received health check-up
Date of disclosure of the study information 2018/11/16
Last modified on 2019/07/09

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Basic information
Public title Questionnaire survey on prescription of PPI (proton pump inhibitor) in participants who received health check-up
Acronym Questionnaire survey on prescription of PPI (proton pump inhibitor) in participants who received health check-up
Scientific Title Questionnaire survey on prescription of PPI (proton pump inhibitor) in participants who received health check-up
Scientific Title:Acronym Questionnaire survey on prescription of PPI (proton pump inhibitor) in participants who received health check-up
Region
Japan

Condition
Condition reflux esophagitis
Classification by specialty
Medicine in general Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 we investigate Whether esophagogastroduodenoscopic screening leads to inappropriate prescription of PPI.
Basic objectives2 Others
Basic objectives -Others Investigate the frequency of inappropriate prescription of PPI.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Among PPI users, the proportion at which the endoscope in health check-up caused inappropriate prescription of PPI.
Key secondary outcomes Among PPI users, the proportion of inappropriate prescription of PPI.
Among PPI users, the proportion of patients with the Progressed gastric fundus polyps.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Among our institutional health check-up, participants who is prescribed PPI.
Key exclusion criteria Participants who refused to investigate.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenichiro MAJIMA
Organization Kameda Medical Center
Division name Department of Health Management,
Zip code
Address 929 Higashi-cho, Kamogawa City, Chiba Prefecture, Japan
TEL 04-7092-2211
Email majima.kenichiro@kameda.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kenichiro MAJIMA
Organization Kameda Medical Center
Division name Department of Health Management
Zip code
Address 929 Higashi-cho, Kamogawa City, Chiba Prefecture, Japan
TEL 04-7092-2211
Homepage URL
Email majima.kenichiro@kameda.jp

Sponsor
Institute Kameda Medical Center
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2018 Year 11 Month 16 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 11 Month 10 Day
Date of IRB
2018 Year 11 Month 12 Day
Anticipated trial start date
2019 Year 07 Month 08 Day
Last follow-up date
2020 Year 02 Month 29 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We will investigate the following in the questionnaire. Symptoms of GERD. What was the reason for starting PPI prescription? Frequency and duration of using PPI. Changes in the PPI dose. Does the doctor Periodically evaluate your GERD?
We also evaluate endoscopic results.

Management information
Registered date
2018 Year 11 Month 15 Day
Last modified on
2019 Year 07 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039485

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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