UMIN-CTR Clinical Trial

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	Completed
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	2021 Year 03 Month 24 Day
Date trial data considered complete	2021 Year 03 Month 24 Day
Date analysis concluded	2021 Year 03 Month 24 Day

Other
Other related information

Management information
Registered date	2021 Year 01 Month 11 Day
Last modified on	2021 Year 06 Month 23 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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