UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034905 |
|---|---|
| Receipt number | 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 | 2022/05/18 12:19:46 |
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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
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
majima.kenichiro@kameda.jp
Sponsor or person
Institute
Kameda Medical Center
Institute
Department
Personal name
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
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
No longer 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
| 2022 | Year | 05 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039485
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
