UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison of acid inhibition attained by esomeprazole and vonoprazan with reference to CYP2C19 genotypes
Title of the study (Brief title)	Comparison of esomeprazole and vonoprazan
Region	Japan

Condition
Condition	H. pylori infection and gastro-esophageal reflux desease
Classification by specialty	Gastroenterology Adult
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	The aim of this study is to compare acid inhibitory effects of vonoprazan and esomeprazole in relation to CYP2C19 genotype.
Basic objectives2	Pharmacodynamics
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	The primary outcome is acid inhibition with the four regimens as assessed by 24-hour intragastric pH monitoring on Day7 in each regimen.
Key secondary outcomes	The secondary outcomes is serum gastrin level on Day 7 with each regimen as a surrogate marker of acid inhibition.

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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	10
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	There are four regimens as follows; (1) vonoprazan 20 mg twice daily for 7 days, (2) vonoprazan 20 mg once daily for 7 days, (3) esomeprazole 20 mg twice daily for 7 days, and (4) esomeprazole 20 mg once daily for 7 days. Subjects receive the four different regimens in a crossover manner. The order of the four regimens is randomized as "interventions 1-24". "Interventions 11-24" are mentioned in "other related information", because of lack of the space. A clinical research coordinator manages the dosing schedule of each subject. The washout period between the different regimens is at least 2 weeks. In each regimen, 24-h intragastric pH monitoring is performed on Day 7. Interventions 1; regimen (1), washout (at least 2 weeks), regimen (2), washout (at least 2 weeks), regimen (3), washout (at least 2 weeks), and regimen (4)
Interventions/Control_2	Interventions 2; regimen (1), washout (at least 2 weeks), regimen (2), washout (at least 2 weeks), regimen (4), washout (at least 2 weeks), and regimen (3)
Interventions/Control_3	Interventions 3; regimen (1), washout (at least 2 weeks), regimen (3), washout (at least 2 weeks), regimen (2), washout (at least 2 weeks), and regimen (4)
Interventions/Control_4	Interventions 4; regimen (1), washout (at least 2 weeks), regimen (3), washout (at least 2 weeks), regimen (4), washout (at least 2 weeks), and regimen (2)
Interventions/Control_5	Interventions 5; regimen (1), washout (at least 2 weeks), regimen (4), washout (at least 2 weeks), regimen (2), washout (at least 2 weeks), and regimen (3)
Interventions/Control_6	Interventions 6; regimen (1), washout (at least 2 weeks), regimen (4), washout (at least 2 weeks), regimen (3), washout (at least 2 weeks), and regimen (2)
Interventions/Control_7	Interventions 7; regimen (2), washout (at least 2 weeks), regimen (1), washout (at least 2 weeks), regimen (3), washout (at least 2 weeks), and regimen (4)
Interventions/Control_8	Interventions 8; regimen (2), washout (at least 2 weeks), regimen (1), washout (at least 2 weeks), regimen (4), washout (at least 2 weeks), and regimen (3)
Interventions/Control_9	Interventions 9; regimen (2), washout (at least 2 weeks), regimen (3), washout (at least 2 weeks), regimen (1), washout (at least 2 weeks), and regimen (4)
Interventions/Control_10	Interventions 10; regimen (2), washout (at least 2 weeks), regimen (3), washout (at least 2 weeks), regimen (4), washout (at least 2 weeks), and regimen (1)

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Healthy Japanese men and women
Key exclusion criteria	Exclusion criteria are any underlying disease, smoking habit, past or present H. pylori infection, and habitual use of any medicine.
Target sample size	30

Research contact person
Name of lead principal investigator	Takuma Kagami
Organization	Hamamatsu University School of Medicine
Division name	First Department of Medicine
Address	1-20-1 Handayama, Higasi-ku, Hamamatsu-shi, Shizuoka, Japan
TEL	+81-53-435-2111
Email	D14029@hama-med.ac.jp

Public contact
Name of contact person	Takahisa Furuta
Organization	Hamamatsu University School of Medicine
Division name	Center for Clinical Research
Address	1-20-1 Handayama, Higasi-ku, Hamamatsu-shi, Shizuoka, Japan
TEL	+81-53-435-2261
Homepage URL
Email	furuta@hama-med.ac.jp

Sponsor
Institute	First Department of Medicine and Center for Clinical Research, Hamamatsu University School of Medicine, Hamamatsu, Japan
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	This work was supported by a grant-in-aid from the Ministry of Education, Culture, Sports, Science and Technology of Japan (20590718).
Organization
Division
Category of Funding Organization
Nationality of Funding Organization	Japan

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	浜松医科大学病院（静岡県）

Other administrative information
Date of disclosure of the study information	2015 Year 11 Month 21 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 01 Month 06 Day
Anticipated trial start date	2015 Year 02 Month 16 Day
Last follow-up date	2015 Year 09 Month 21 Day
Date of closure to data entry	2015 Year 09 Month 21 Day
Date trial data considered complete	2015 Year 09 Month 21 Day
Date analysis concluded	2015 Year 09 Month 24 Day

Related information
URL releasing protocol	http://onlinelibrary.wiley.com/doi/10.1111/apt.13588/full
Publication of results	Published
URL releasing results	http://onlinelibrary.wiley.com/doi/10.1111/apt.13588/full
Results	T. Kagami et al. Aliment Pharmacol Ther. 2016 May; 43 (10): 1048-59
Other related information	Interventions 11; regimen (2), washout (at least 2 weeks), regimen (4), washout (at least 2 weeks), regimen (1), washout (at least 2 weeks), and regimen (3) Interventions 12; regimen (2), washout, regimen (4), washout, regimen (3), washout, and regimen (1) Interventions 13; regimen (3), washout, regimen (1), washout, regimen (2), washout, and regimen (4) Interventions 14; regimen (3), washout, regimen (1), washout, regimen (4), washout, and regimen (2) Interventions 15; regimen (3), washout, regimen (2), washout, regimen (1), washout, and regimen (4) Interventions 16; regimen (3), washout, regimen (2), washout, regimen (4), washout, and regimen (1) Interventions 17; regimen (3), washout, regimen (4), washout, regimen (1), washout, and regimen (2) Interventions 18; regimen (3), washout, regimen (4), washout, regimen (2), washout, and regimen (1) Interventions 19; regimen (4), washout, regimen (1), washout, regimen (2), washout, and regimen (3) Interventions 20; regimen (4), washout, regimen (1), washout, regimen (3), washout, and regimen (2) Interventions 21; regimen (4), washout, regimen (2), washout, regimen (1), washout, and regimen (3) Interventions 22; regimen (4), washout, regimen (2), washout, regimen (3), washout, and regimen (1) Interventions 23; regimen (4), washout, regimen (3), washout, regimen (1), washout, and regimen (2) Interventions 24; regimen (4), washout, regimen (3), washout, regimen (2), washout, and regimen (1)

Management information
Registered date	2015 Year 11 Month 21 Day
Last modified on	2016 Year 05 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022976