UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025469 |
|---|---|
| Receipt number | R000029292 |
| Scientific Title | Effect of gastric acid suppression by use of vonoplazan |
| Date of disclosure of the study information | 2016/12/31 |
| Last modified on | 2017/01/06 21:00:13 |
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Basic information
Public title
Effect of gastric acid suppression by use of vonoplazan
Acronym
Effect of gastric acid suppression by use of vonoplazan
Scientific Title
Effect of gastric acid suppression by use of vonoplazan
Scientific Title:Acronym
Effect of gastric acid suppression by use of vonoplazan
Region
| Japan |
Condition
Condition
healthy person
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of gastric acid suppression by use of vonoprazan
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
gastric acid secretion (1day before administration, 6 days in administration, 3days after administration)
Key secondary outcomes
Serum gastrin levels
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
administration of vonoprazan
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 45 | years-old | > |
Gender
Male
Key inclusion criteria
(1)Healthy Japanese adult males.
(2)Between the ages of 20-45 at the time of informed consent.
(3)Subjects signed informed consent form voluntary.
Key exclusion criteria
(1)Subjects with history of gastric ulcer or duodenum ulcer
(2)Subjects with a serious complication of liver failure
(3)Subjects with a serious complication of renal failure
(4)Subjects with a serious complication of heart failure
(5)Subjects treated with atazanavir sulfate (Reyataz) or rilpivirine hydrochloride (Edurant)
(6)Subjects with Zollinger-Ellison syndrome
(7)Subjects with history of surgery that affects gastric-acid secretion
(8)Subjects with a history of allergy to the investigational product
(9)Subjects with atrophic gastritis, gastric tumor, gastric ulcer or duodenum ulcer by endoscopic examination.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mototsugu Kato |
Organization
National Hospital Organization Hakodate Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
16-gou, 18-banchi, Kawahara-chou, Hakodate, 041-8512, Japan
TEL
+81-0138-51-6281
mkato1957@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mototsugu Kato |
Organization
National Hospital Organization Hakodate Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
16-gou, 18-banchi, Kawahara-chou, Hakodate, 041-8512, Japan
TEL
+81-0138-51-6281
Homepage URL
mkato1957@gmail.com
Sponsor or person
Institute
National Hospital Organization Hakodate Hospital
Institute
Department
Personal name
Funding Source
Organization
Eisai Co., Ltd.; Takeda Pharmaceutical Co., Ltd.; Daiichi Sankyo Co., Ltd.; and AstraZeneca K.K. and Astellas Pharma Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 12 | Month | 31 | 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
Date of protocol fixation
| 2016 | Year | 11 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 12 | Month | 29 | 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 | 12 | Month | 29 | Day |
Last modified on
| 2017 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029292
