UMIN-CTR Clinical Trial

Basic information
Public title	Comparison of gastric transit time after ingestion of Aquafun and Arginaid Water by ultrasound asseement of gastric volume.
Acronym	Comparison of gastric transit time after ingestion of Aquafun and Arginaid Water.
Scientific Title	Comparison of gastric transit time after ingestion of Aquafun and Arginaid Water by ultrasound asseement of gastric volume.
Scientific Title:Acronym	Comparison of gastric transit time after ingestion of Aquafun and Arginaid Water.
Region	Japan

Condition
Condition	Healthy volunteers
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the difference of gastric transit time after ingestion of Aquafun and Arginaid Water.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The cross-sectional surface area of the gastric antrum measured by ultrasound.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Food Maneuver
Interventions/Control_1	The change of the cross-sectional surface area of the gastric antrum with time after after ingestion of Aquafun and Arginaid Water.
Interventions/Control_2	The change of the cross-sectional surface area of the gastric antrum with time after after ingestion of Aquafun and Arginaid Water.
Interventions/Control_3	The change of the cross-sectional surface area of the gastric antrum with time after after ingestion of 12.5% Sucrose solution.(Control)
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	Not applicable
Gender	Male
Key inclusion criteria	Persons who fills everything the following 1) a person of 20years or more 2) a person who gives written Informed consent
Key exclusion criteria	1. a person who have gastrointestinal lesion. 2. a person who are ineligible in the opinion of the investigator.
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Tadashi Middle name Last name Okabe
Organization	Hitachi, Ltd. Hitachinaka General Hospital
Division name	Department of Anesthesiology
Zip code	312-0057
Address	20-1 Ishikawa-cho Hitachinaka-shi
TEL	029-354-5111
Email	t-okabe@nms.ac.jp

Public contact
Name of contact person	1st name Tadashi Middle name Last name Okabe
Organization	Hitachi, Ltd. Hitachinaka General Hospital
Division name	Department of Anesthesiology
Zip code	312-0057
Address	20-1 Ishikawa-cho Hitachinaka-shi
TEL	029-354-5111
Homepage URL
Email	t-okabe@nms.ac.jp

Sponsor
Institute	Hitachi, Ltd. Hitachinaka General Hospital
Institute
Department

Funding Source
Organization	None
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	Hitachi General Hospital Research Ethics Committee
Address	2-1-1 jyonan-cho Hitachi-shi Ibaraki 317-0077 JAPAN
Tel	029-423-8333
Email	masahiro.miura.cz@hitachi.com

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	2019 Year 10 Month 24 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	Delay expected
Results Delay Reason	Preparing to submit
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	2019 Year 08 Month 06 Day
Date of IRB	2019 Year 10 Month 07 Day
Anticipated trial start date	2019 Year 10 Month 24 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 10 Month 24 Day
Last modified on	2021 Year 10 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043734