UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019890
Receipt No. R000022976
Scientific Title Comparison of acid inhibition attained by esomeprazole and vonoprazan with reference to CYP2C19 genotypes
Date of disclosure of the study information 2015/11/21
Last modified on 2016/05/11

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
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
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.

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)

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
Last 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

Public contact
1st 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

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

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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol http://onlinelibrary.wiley.com/doi/10.1111/apt.13588/full
Publication of results Published

Result
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

Progress
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
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.