UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022198 |
|---|---|
| Receipt number | R000025547 |
| Scientific Title | Acid-inhibitory effects of vonoprazan compared with rabeprazole in healthy adult subjects - a randomised open-label cross-over study |
| Date of disclosure of the study information | 2016/06/01 |
| Last modified on | 2019/02/14 19:17:07 |
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Basic information
Public title
Acid-inhibitory effects of vonoprazan compared with rabeprazole in healthy adult subjects - a randomised open-label cross-over study
Acronym
Acid-inhibitory effects of vonoprazan compared with rabeprazole in healthy adult subjects - a randomised open-label cross-over study
Scientific Title
Acid-inhibitory effects of vonoprazan compared with rabeprazole in healthy adult subjects - a randomised open-label cross-over study
Scientific Title:Acronym
Acid-inhibitory effects of vonoprazan compared with rabeprazole in healthy adult subjects - a randomised open-label cross-over study
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy,rapidity and duration of acid-inhibitory effects of vonoprazan vs rabeprazole.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate that vonoprazan show a signifcant acid suppressant effect against rabeprazole by comparing an acid suppressant effect on gastric pH (pH holding time at no less than pH3, pH4, and pH5) between vonoprazan and rabeprazole
Key secondary outcomes
Acid suppressant effect by the CYP2C19 genetic polymorphism.
Nighttime acid suppressant effect.
An incidence of all adverse events.
Acid suppressant effect before and after a meal.
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
6
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Subjects are administrated rabeprazole 20mg after administrated vonoprazan 20mg.
Interventions/Control_2
Subjects are administrated vonoprazan 20mg after administrated rabeprazole 20mg.
Interventions/Control_3
Subjects are administrated rabeprazole 40mg after administrated vonoprazan 20mg.
Interventions/Control_4
Subjects are administrated vonoprazan 20mg after administrated rabeprazole 40mg.
Interventions/Control_5
Subjects are administrated rabeprazole 20mg after administrated vonoprazan 10mg.
Interventions/Control_6
Subjects are administrated vonoprazan 10mg after administrated rabeprazole 20mg.
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 and Female
Key inclusion criteria
20 years of age or more
Key exclusion criteria
1) by constriction or deformation of the upper gastrointestinal tract, drug administration and the endoscope insertion difficult.
2) there is a history of acid-related diseases.
3) there is a surgical history.
4) there is a history of radiation therapy to the upper abdomen.
5) serious complications(with heart failure, kidney failure, liver failure, respiratory failure).
6) Experience of oral administration of Vonoprazan or Rabeprazole.
7) there is a history of medication to up to one month before the registration date.
8) there is a history eradication of Helicobacter pylori.
9) Helicobacter pylori test positive (anti-HP IgG antibody, urease test, any one is positive urea breath test).
10) There is activity malignant tumor patients and other serious systemic complication.
11) there are abnormal findings in the upper gastrointestinal endoscopy.
12) F scale positive (total score 8 points or more)
13) There is a history of allergy to test drugs
14) pregnancy and lactation.
15) there is a plan of treatment with respect to the upper gastrointestinal tract disease.
16) there is a registration history in the study.
17) can not be obtained the consent to participate in this clinical study.
18) the study director (sharing) who doctor has determined to be inappropriate as a subject.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhide Higuchi |
Organization
Osaka medical collage
Division name
second department of internal medicine
Zip code
Address
2-7, Daigakumachi, Takatsuki city, Osaka
TEL
0726831221
taisyatyou3tyoume@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuichi Kojima |
Organization
Osaka medical collage
Division name
second department of internal medicine
Zip code
Address
2-7, Daigakumachi, Takatsuki city, Osaka
TEL
0726831221
Homepage URL
in2134@osaka-med.ac.jp
Sponsor or person
Institute
Osaka medical collage
Institute
Department
Personal name
Funding Source
Organization
EA Pharma Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Gunma University,Yokohama City University,Hamamatsu University School of Medicine,Aichi Medical University,Osaka City University,Saga University,Oita University,University of Miyazaki,Shiga University of Medical Science,Okayama University
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
| 2016 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 03 | Day |
Last modified on
| 2019 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025547
