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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000041986
Receipt No. R000047905
Scientific Title Safety evaluation test for 4-week continuous intake of foods containing SNR14 in healthy volunteers
Date of disclosure of the study information 2020/10/02
Last modified on 2020/11/03

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Basic information
Public title Safety evaluation test for 4-week continuous intake of foods containing SNR14 in healthy volunteers
Acronym Safety evaluation test for 4-week continuous intake of foods containing SNR14 in healthy volunteers
Scientific Title Safety evaluation test for 4-week continuous intake of foods containing SNR14 in healthy volunteers
Scientific Title:Acronym Safety evaluation test for 4-week continuous intake of foods containing SNR14 in healthy volunteers
Region
Japan

Condition
Condition Healthy Volunteer
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluate the safety of healthy volunteers by continuously intake of foods containing SNR14.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes (Safety evaluation)
Blood test items,urinalysis items,general physical findings (subjective symptoms,objective findings),vital signs(blood pressure,pulse rate),physical measurements(body weight,body fat percentage,lean body mass),frequency of adverse events
(Measurement item)
Urinary excretion of SNR14,Plasma concentration of SNR14
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 4-weeks intake of SNR14-containing food
Interventions/Control_2 4-weeks intake of the placebo food
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
79 years-old >=
Gender Male and Female
Key inclusion criteria 1)Subjects who have obtained written consent for participation in the research.
2)Healthy men and women between 20 and 79.
3)Subject who can take meals, eat test foods, etc., take blood samples, take urine samples, and stay quiet and rest on the schedule indicated by investigators.
Key exclusion criteria 1)Subjects whose clinical inspection results are outside of the normal range and who are est imated inappropriate to this study.
2)Subjects who had a serious major organ / internal organ or who are currently undergoing treatment and who are estimated inappropriate to this study.
3)As a general rule, those who regularly use drugs for the purpose of treating diseases.
4)Subjects who have allergy.
5)Lactating people, pregnant women or those who may be pregnant, and those who wish to become pregnant during the study period.
6)Subjects who are estimated inappropriate to this study by principal investigator or investigators.
Target sample size 48

Research contact person
Name of lead principal investigator
1st name Daisuke
Middle name
Last name Ochitani
Organization HUMA R&D CORP
Division name Clinical Development Division
Zip code 108-0014
Address Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL 03-3431-1260
Email ochitani@huma-rd.co.jp

Public contact
Name of contact person
1st name Daisuke
Middle name
Last name Ochitani
Organization HUMA R&D CORP
Division name Clinical Development Division
Zip code 108-0014
Address Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL 03-3431-1260
Homepage URL
Email ochitani@huma-rd.co.jp

Sponsor
Institute HUMA R&D CORP
Institute
Department

Funding Source
Organization Otsuka Pharmaceutical Co., Ltd.
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 AMC Nishi-Umeda Clinic Ethical Review Committee
Address West Umeda Building 3F 3-3-45 Umeda Kita-ku Osaka Japan,530-0001
Tel 06-4797-5660
Email jimukyoku@amc-clinc.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 10 Month 02 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 No longer recruiting
Date of protocol fixation
2020 Year 09 Month 23 Day
Date of IRB
2020 Year 09 Month 24 Day
Anticipated trial start date
2020 Year 10 Month 05 Day
Last follow-up date
2020 Year 12 Month 18 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 10 Month 02 Day
Last modified on
2020 Year 11 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047905

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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