UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039199 |
|---|---|
| Receipt number | R000044702 |
| Scientific Title | Examination on change of gastric emptying ability by acid secretion suppression |
| Date of disclosure of the study information | 2020/01/20 |
| Last modified on | 2021/06/23 20:19:13 |
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Basic information
Public title
Examination on change of gastric emptying ability by acid secretion suppression
Acronym
Examination on change of gastric emptying ability by acid secretion suppression
Scientific Title
Examination on change of gastric emptying ability by acid secretion suppression
Scientific Title:Acronym
Examination on change of gastric emptying ability by acid secretion suppression
Region
| Japan |
Condition
Condition
Reflux Esophagitis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study of aim is to confirm the influence for gastric emptying by the gastric acid secretion.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Determine how gastric emptying is related to gastric emptying by measuring gastric emptying using the 13C breath test gastric emptying test.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Other |
Interventions/Control_1
Vonoprazan is available in 10mg and 20mg formulations, each for 2 weeks. 13C Breath test Gastric emptying test is performed before, after taking 10 mg and after taking 20 mg 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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy volunteers
Key exclusion criteria
Persons who do not fit the above
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Kazuhide |
| Middle name | |
| Last name | Higuchi |
Organization
Osaka medical college
Division name
Second department of internal medicine
Zip code
569-8686
Address
2-7, Daigaku-machi, Takatsuki
TEL
072-683-1221
higuchi@osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Ota |
Organization
Osaka medical college
Division name
Second department of internal medicine
Zip code
569-8686
Address
2-7, Daigaku-machi, Takatsuki
TEL
072-683-1221
Homepage URL
clash_kaz@yathoo.co.jp
Sponsor or person
Institute
Osaka medical college
Institute
Department
Personal name
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethic review committee at osaka medical college
Address
2-7, Daigaku-machi, Takatsuki
Tel
072-683-1221
omc_rinsyou@osaka-med.ac.jp
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
| 2020 | Year | 01 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
10
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
| 2020 | Year | 01 | Month | 18 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 18 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 19 | Day |
Last follow-up date
| 2020 | Year | 07 | Month | 20 | Day |
Date of closure to data entry
| 2020 | Year | 07 | Month | 20 | Day |
Date trial data considered complete
| 2020 | Year | 07 | Month | 20 | Day |
Date analysis concluded
| 2020 | Year | 07 | Month | 21 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 01 | Month | 19 | Day |
Last modified on
| 2021 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044702
