UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison of the effect of 20mg Vonoprazan,30mg,Lansoprazole and 20mg Famotidine on intragastric pH: A three-way crossover study
Title of the study (Brief title)	Comparison of the effect of 20mg Vonoprazan,30mg,Lansoprazole and 20mg Famotidine on intragastric pH
Region	Japan

Condition
Condition	reflux esophagitis
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	The ideal medication for treatment of acid related diseases should have a rapid onset of action to promote hemostasis and symptoms. No studies have compared directly the intragastric pH of Vonoprazan that is a new class of proton pomp inhibitor (PPI), Lansoprazole and Famotidine
Basic objectives2	Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	intragastric pH by pH meter attached to the antimony pH electrode for 6 hour after administration
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Vonoprazan20mg-(washout period)-Lansoprazole30mg-(washout period)-Famotidine20mg
Interventions/Control_2	Lansoprazole30mg-(washout period)-Vonoprazan20mg-(washout period)-Famotidine20mg
Interventions/Control_3	Famotidine20mg-(washout period)-Lansoprazole30mg-(washout period)-Vonoprazan20mg
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
Key inclusion criteria	Patient who fills everything the following 1) Helicobacter pylori-negative male Patient 2) Patient of 20 years or more 3) Patient who gives written informed consent
Key exclusion criteria	The patient who collides with either the following assumes that it doesn't put it in to the examination 1) Drug allergy 2) Patient who took medicine that influences movement and function of digestive tract such as proton pump inhibitor, H2 blocker, and NSAIDs within 4 weeks
Target sample size	15

Research contact person
Name of lead principal investigator	Masahiko Inamori
Organization	Yokohama City University School of Medicine
Division name	Department of Medical Education
Address	3-9 Fuku-ura, Kanazawa-ku, Yokohama, Japan
TEL	045-787-2626
Email	inamorim@yokohama-cu.ac.jp

Public contact
Name of contact person	Hiroshi Iida
Organization	Yokohama City University School of Medicine
Division name	Department of Medical Education
Address	3-9 Fuku-ura, Kanazawa-ku, Yokohama, Japan
TEL	045-787-2800
Homepage URL
Email	hiro0905@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University School of Medicine Department of Medical Education
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
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	横浜市立大学医学部

Other administrative information
Date of disclosure of the study information	2016 Year 02 Month 22 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 02 Month 12 Day
Anticipated trial start date	2016 Year 03 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 02 Month 12 Day
Last modified on	2018 Year 02 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024230