UMIN-CTR Clinical Trial

Basic information
Public title	Examination on change of gastric emptying ability by acid secretion suppression
Acronym	Examination on change of gastric emptying ability by acid secretion suppression
Scientific Title	Examination on change of gastric emptying ability by acid secretion suppression
Scientific Title:Acronym	Examination on change of gastric emptying ability by acid secretion suppression
Region	Japan

Condition
Condition	Reflux Esophagitis
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study of aim is to confirm the influence for gastric emptying by the gastric acid secretion.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Determine how gastric emptying is related to gastric emptying by measuring gastric emptying using the 13C breath test gastric emptying test.
Key secondary outcomes

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 Other
Interventions/Control_1	Vonoprazan is available in 10mg and 20mg formulations, each for 2 weeks. 13C Breath test Gastric emptying test is performed before, after taking 10 mg and after taking 20 mg of vonoprazan.
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	65 years-old >
Gender	Male and Female
Key inclusion criteria	Healthy volunteers
Key exclusion criteria	Persons who do not fit the above
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Kazuhide Middle name Last name Higuchi
Organization	Osaka medical college
Division name	Second department of internal medicine
Zip code	569-8686
Address	2-7, Daigaku-machi, Takatsuki
TEL	072-683-1221
Email	higuchi@osaka-med.ac.jp

Public contact
Name of contact person	1st name Kazuhiro Middle name Last name Ota
Organization	Osaka medical college
Division name	Second department of internal medicine
Zip code	569-8686
Address	2-7, Daigaku-machi, Takatsuki
TEL	072-683-1221
Homepage URL
Email	clash_kaz@yathoo.co.jp

Sponsor
Institute	Osaka medical college
Institute
Department

Funding Source
Organization	Self-funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Ethic review committee at osaka medical college
Address	2-7, Daigaku-machi, Takatsuki
Tel	072-683-1221
Email	omc_rinsyou@osaka-med.ac.jp

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	2020 Year 01 Month 20 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled	10
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	Completed
Date of protocol fixation	2020 Year 01 Month 18 Day
Date of IRB	2020 Year 01 Month 18 Day
Anticipated trial start date	2020 Year 01 Month 19 Day
Last follow-up date	2020 Year 07 Month 20 Day
Date of closure to data entry	2020 Year 07 Month 20 Day
Date trial data considered complete	2020 Year 07 Month 20 Day
Date analysis concluded	2020 Year 07 Month 21 Day

Other
Other related information

Management information
Registered date	2020 Year 01 Month 19 Day
Last modified on	2021 Year 06 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044702