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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028712
Receipt No. R000032866
Scientific Title The assessment of gastrin level and gastric histology in long-term PPI or vonoprazan users.
Date of disclosure of the study information 2017/12/01
Last modified on 2019/02/20

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Basic information
Public title The assessment of gastrin level and gastric histology in long-term PPI or vonoprazan users.
Acronym The assessment of gastric histology in lon-term PPI users.
Scientific Title The assessment of gastrin level and gastric histology in long-term PPI or vonoprazan users.
Scientific Title:Acronym The assessment of gastric histology in lon-term PPI users.
Region
Japan

Condition
Condition GERD patients with long-term PPI or vonoprazan using
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The assessment of gastric histology in long-term PPI or vonoprazan users.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes gastric histology
Key secondary outcomes long-term PPI or vonoprazan gastrin level, esophageal mucosal healing and symptom

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
90 years-old >=
Gender Male and Female
Key inclusion criteria GERD patients with long-term PPI or vonoprazan using
Key exclusion criteria GERD patients with not continuous PPI or vonoprazan using( 1 year at least)
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kouichi Sakurai
Organization Hattori clinic
Division name Hattori Clinic
Zip code
Address 2-12-35 Shin-machi, chuo-ku, Kumamoto City, Kumamoto 860-0004, Japan
TEL +81-96-325-2300
Email sakuraiko@jcom.zaq.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name kouichi Sakurai
Organization Hattori Clinic
Division name Hattori Clinic
Zip code
Address 2-12-35 Shin-machi, chuo-ku, Kumamoto City, Kumamoto 860-0004, Japan
TEL +81-96-325-2300
Homepage URL
Email sakuraiko@jcom.zaq.ne.jp

Sponsor
Institute Hattori Clinic
Institute
Department

Funding Source
Organization Hattori Clinic
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
2017 Year 12 Month 01 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
2017 Year 08 Month 17 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The assessment of gastrin level and gastric histology every year if GERD patients take continuous PPI or vonoprazan .

Management information
Registered date
2017 Year 08 Month 17 Day
Last modified on
2019 Year 02 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032866

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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