UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Acid-inhibitory effects of vonoprazan compared with rabeprazole in healthy adult subjects - a randomised open-label cross-over study
Title of the study (Brief title)	Acid-inhibitory effects of vonoprazan compared with rabeprazole in healthy adult subjects - a randomised open-label cross-over study
Region	Japan

Condition
Condition	Healthy subjects
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate efficacy,rapidity and duration of acid-inhibitory effects of vonoprazan vs rabeprazole.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To evaluate that vonoprazan show a signifcant acid suppressant effect against rabeprazole by comparing an acid suppressant effect on gastric pH (pH holding time at no less than pH3, pH4, and pH5) between vonoprazan and rabeprazole
Key secondary outcomes	Acid suppressant effect by the CYP2C19 genetic polymorphism. Nighttime acid suppressant effect. An incidence of all adverse events. Acid suppressant effect before and after a meal.

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	6
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Subjects are administrated rabeprazole 20mg after administrated vonoprazan 20mg.
Interventions/Control_2	Subjects are administrated vonoprazan 20mg after administrated rabeprazole 20mg.
Interventions/Control_3	Subjects are administrated rabeprazole 40mg after administrated vonoprazan 20mg.
Interventions/Control_4	Subjects are administrated vonoprazan 20mg after administrated rabeprazole 40mg.
Interventions/Control_5	Subjects are administrated rabeprazole 20mg after administrated vonoprazan 10mg.
Interventions/Control_6	Subjects are administrated vonoprazan 10mg after administrated rabeprazole 20mg.
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	20 years of age or more
Key exclusion criteria	1) by constriction or deformation of the upper gastrointestinal tract, drug administration and the endoscope insertion difficult. 2) there is a history of acid-related diseases. 3) there is a surgical history. 4) there is a history of radiation therapy to the upper abdomen. 5) serious complications(with heart failure, kidney failure, liver failure, respiratory failure). 6) Experience of oral administration of Vonoprazan or Rabeprazole. 7) there is a history of medication to up to one month before the registration date. 8) there is a history eradication of Helicobacter pylori. 9) Helicobacter pylori test positive (anti-HP IgG antibody, urease test, any one is positive urea breath test). 10) There is activity malignant tumor patients and other serious systemic complication. 11) there are abnormal findings in the upper gastrointestinal endoscopy. 12) F scale positive (total score 8 points or more) 13) There is a history of allergy to test drugs 14) pregnancy and lactation. 15) there is a plan of treatment with respect to the upper gastrointestinal tract disease. 16) there is a registration history in the study. 17) can not be obtained the consent to participate in this clinical study. 18) the study director (sharing) who doctor has determined to be inappropriate as a subject.
Target sample size	30

Research contact person
Name of lead principal investigator	Kazuhide Higuchi
Organization	Osaka medical collage
Division name	second department of internal medicine
Address	2-7, Daigakumachi, Takatsuki city, Osaka
TEL	0726831221
Email	taisyatyou3tyoume@yahoo.co.jp

Public contact
Name of contact person	Yuichi Kojima
Organization	Osaka medical collage
Division name	second department of internal medicine
Address	2-7, Daigakumachi, Takatsuki city, Osaka
TEL	0726831221
Homepage URL
Email	in2134@osaka-med.ac.jp

Sponsor
Institute	Osaka medical collage
Institute
Department

Funding Source
Organization	EA Pharma Co.,Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Gunma University,Yokohama City University,Hamamatsu University School of Medicine,Aichi Medical University,Osaka City University,Saga University,Oita University,University of Miyazaki,Shiga University of Medical Science,Okayama University
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 06 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 05 Month 01 Day
Anticipated trial start date	2016 Year 06 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 05 Month 03 Day
Last modified on	2019 Year 02 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025547