UMIN-CTR Clinical Trial

Public title

Comparison of acid inhibition attained by esomeprazole and vonoprazan with reference to CYP2C19 genotypes

Acronym

Comparison of esomeprazole and vonoprazan

Scientific Title

Comparison of acid inhibition attained by esomeprazole and vonoprazan with reference to CYP2C19 genotypes

Scientific Title:Acronym

Comparison of esomeprazole and vonoprazan

Region

Japan

Condition

H. pylori infection and gastro-esophageal reflux desease

Classification by specialty

Gastroenterology

Adult

Classification by malignancy

Others

Genomic information

YES

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

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.

Study type

Interventional

Basic design

Cross-over

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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)

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

Name of lead principal investigator

1st name
Middle name
Last name	Takuma Kagami

Organization

Hamamatsu University School of Medicine

Division name

First Department of Medicine

Zip code

Address

1-20-1 Handayama, Higasi-ku, Hamamatsu-shi, Shizuoka, Japan

TEL

+81-53-435-2111

Email

D14029@hama-med.ac.jp

Name of contact person

1st name
Middle name
Last name	Takahisa Furuta

Organization

Hamamatsu University School of Medicine

Division name

Center for Clinical Research

Zip code

Address

1-20-1 Handayama, Higasi-ku, Hamamatsu-shi, Shizuoka, Japan

TEL

+81-53-435-2261

Homepage URL

Email

furuta@hama-med.ac.jp

Institute

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

Institute

Department

Personal name

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

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

浜松医科大学病院（静岡県）　

Date of disclosure of the study information

2015

Year

11

Month

21

Day

URL releasing protocol

http://onlinelibrary.wiley.com/doi/10.1111/apt.13588/full

Publication of results

Published

URL related to results and publications

http://onlinelibrary.wiley.com/doi/10.1111/apt.13588/full

Number of participants that the trial has enrolled

Results

T. Kagami et al. Aliment Pharmacol Ther. 2016 May; 43 (10): 1048-59

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

Recruitment status

Completed

Date of protocol fixation

2015

Year

01

Month

06

Day

Date of IRB

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

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)

Registered date

2015

Year

11

Month

21

Day

Last modified on

2016

Year

05

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022976