UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019890 |
|---|---|
| Receipt number | 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 12:40:40 |
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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
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
D14029@hama-med.ac.jp
Public contact
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
furuta@hama-med.ac.jp
Sponsor or person
Institute
First Department of Medicine and Center for Clinical Research, Hamamatsu University School of Medicine, Hamamatsu, Japan
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022976
