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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000042969
Receipt No. R000049054
Scientific Title Study on the change of gastric emptying ability by vonoprazan
Date of disclosure of the study information 2021/01/12
Last modified on 2021/01/11

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Basic information
Public title Study on the change of gastric emptying ability by vonoprazan
Study on changes in gastric emptying ability due to suppression of acid secretion
Acronym Study on the change of gastric emptying ability by vonoprazan
Scientific Title Study on the change of gastric emptying ability by vonoprazan
Scientific Title:Acronym Study on the change of gastric emptying ability by vonoprazan
Region
Japan

Condition
Condition functional gastrointestinal disorder
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine how vonoprazan treatment alters gastric emptying capacity in healthy subjects.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes gastric emptying breath 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
Interventions/Control_1 gastric emptying breath test
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
75 years-old >
Gender Male and Female
Key inclusion criteria Asymptomatic adults aged 20 to 75 years who participated in UMIN000039199.
Key exclusion criteria Those who have symptoms of gastric acid reflux or gastric motility insufficiency. Patients with a history of gastrectomy. Patients with active malignancy. Patients with serious complications (heart failure, renal failure, liver failure, respiratory failure, intestinal obstruction) that make it difficult to perform the test. Patients with active gastric ulcer. Patients on dialysis. Pregnant or nursing mothers. Patients with swallowing dysfunction. Those who are allergic to bonoprazan. Patients who cannot express their own will due to dementia or impaired consciousness. Those who are unable to give their consent. Those who are judged as unsuitable as test subjects by the principal investigator (sub-investigator).
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-City, Osaka
TEL 072-683-1221
Email 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-City, Osaka
TEL 072-683-1221
Homepage URL
Email in2112@osaka-med.ac.jp

Sponsor
Institute Second Department of Internal Medicine, Osaka Medical College
Institute
Department

Funding Source
Organization Second Department of Internal Medicine, Osaka Medical College
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 Osaka Medical College
Address 2-7, Daigaku-Machi, Takatsuki-City, Osaka
Tel 072-683-1221
Email 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
2021 Year 01 Month 12 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 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 No longer recruiting
Date of protocol fixation
2021 Year 01 Month 12 Day
Date of IRB
2021 Year 01 Month 15 Day
Anticipated trial start date
2021 Year 01 Month 12 Day
Last follow-up date
2021 Year 02 Month 11 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 01 Month 11 Day
Last modified on
2021 Year 01 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049054

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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