UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of gastric acid suppression by use of vonoplazan
Title of the study (Brief title)	Effect of gastric acid suppression by use of vonoplazan
Region	Japan

Condition
Condition	healthy person
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect of gastric acid suppression by use of vonoprazan
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	gastric acid secretion (1day before administration, 6 days in administration, 3days after administration)
Key secondary outcomes	Serum gastrin levels

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	administration 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	45 years-old >
Gender	Male
Key inclusion criteria	(1)Healthy Japanese adult males. (2)Between the ages of 20-45 at the time of informed consent. (3)Subjects signed informed consent form voluntary.
Key exclusion criteria	(1)Subjects with history of gastric ulcer or duodenum ulcer (2)Subjects with a serious complication of liver failure (3)Subjects with a serious complication of renal failure (4)Subjects with a serious complication of heart failure (5)Subjects treated with atazanavir sulfate (Reyataz) or rilpivirine hydrochloride (Edurant) (6)Subjects with Zollinger-Ellison syndrome (7)Subjects with history of surgery that affects gastric-acid secretion (8)Subjects with a history of allergy to the investigational product (9)Subjects with atrophic gastritis, gastric tumor, gastric ulcer or duodenum ulcer by endoscopic examination.
Target sample size	10

Research contact person
Name of lead principal investigator	Mototsugu Kato
Organization	National Hospital Organization Hakodate Hospital
Division name	Department of Gastroenterology and Hepatology
Address	16-gou, 18-banchi, Kawahara-chou, Hakodate, 041-8512, Japan
TEL	+81-0138-51-6281
Email	mkato1957@gmail.com

Public contact
Name of contact person	Mototsugu Kato
Organization	National Hospital Organization Hakodate Hospital
Division name	Department of Gastroenterology and Hepatology
Address	16-gou, 18-banchi, Kawahara-chou, Hakodate, 041-8512, Japan
TEL	+81-0138-51-6281
Homepage URL
Email	mkato1957@gmail.com

Sponsor
Institute	National Hospital Organization Hakodate Hospital
Institute
Department

Funding Source
Organization	Eisai Co., Ltd.; Takeda Pharmaceutical Co., Ltd.; Daiichi Sankyo Co., Ltd.; and AstraZeneca K.K. and Astellas Pharma Inc.
Organization
Division
Category of Funding Organization	Profit organization
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 31 Day

Progress
Recruitment status	Recruiting
Date of protocol fixation	2016 Year 11 Month 14 Day
Anticipated trial start date	2016 Year 12 Month 29 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 29 Day
Last modified on	2017 Year 01 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029292