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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000025238
Receipt No. R000029029
Scientific Title A study on evaluation gastric acid pocket by vertical 8 channel pH monitoring system and the effect of vonoprazan on gastric acid pocket
Date of disclosure of the study information 2016/12/13
Last modified on 2016/12/12

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Basic information
Public title A study on evaluation gastric acid pocket by vertical 8 channel pH monitoring system and the effect of vonoprazan on gastric acid pocket
Acronym Evaluation of gastric acid pocket by 8ch pH monitoring system
Scientific Title A study on evaluation gastric acid pocket by vertical 8 channel pH monitoring system and the effect of vonoprazan on gastric acid pocket
Scientific Title:Acronym Evaluation of gastric acid pocket by 8ch pH monitoring system
Region
Japan

Condition
Condition Gastroesophageal reflux disease
Classification by specialty
Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We use vertical 8 channelpH monitoring system and evaluate acid pocket,which is high acidity layer in stomach after meal.
Next we evaluate the effect of vonoprazan to acid pocket.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes acid pocket size and formation time
Key secondary outcomes Acid pocket size and change in formation time,adverse event after administering vonoprazan,

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 administer bonoprazan
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 1.Healthy adult over 20-year-old
2.Helicobacter pylori negative
3. Agreement from subjects about this study
Key exclusion criteria 1.Lidocaine or Anilide type local anesthetic Allergies
2.Gastrointestinal resection or
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name shohei sumi
Organization shimane university hospital
Division name department of gastroenterology
Zip code
Address 89-1 Enya-cho,Izumo city,Shimane pref,693-8501,Japan
TEL 0853-20-2190
Email sumi@med.shimane.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name shohei sumi
Organization shimane university hospital
Division name department of gastroenterology
Zip code
Address 89-1 Enya-cho,Izumo city,Shimane pref,693-8501,Japan
TEL 0853-20-2190
Homepage URL
Email sumi@med.shimane.ac.jp

Sponsor
Institute Shimane university
Institute
Department

Funding Source
Organization Shimane university
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
2016 Year 12 Month 13 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
Date of protocol fixation
2016 Year 08 Month 10 Day
Date of IRB
Anticipated trial start date
2016 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

Management information
Registered date
2016 Year 12 Month 12 Day
Last modified on
2016 Year 12 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029029

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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