UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study on evaluation gastric acid pocket by vertical 8 channel pH monitoring system and the effect of vonoprazan on gastric acid pocket
Title of the study (Brief title)	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	shohei sumi
Organization	shimane university hospital
Division name	department of gastroenterology
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	shohei sumi
Organization	shimane university hospital
Division name	department of gastroenterology
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)

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

Progress
Recruitment status	Recruiting
Date of protocol fixation	2016 Year 08 Month 10 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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