UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041986 |
|---|---|
| Receipt number | 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 | 2021/05/06 09:37:51 |
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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
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
ochitani@huma-rd.co.jp
Sponsor or person
Institute
HUMA R&D CORP
Institute
Department
Personal name
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
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
48
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 | 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
| 2020 | Year | 12 | Month | 24 | Day |
Date trial data considered complete
| 2021 | Year | 01 | Month | 07 | Day |
Date analysis concluded
| 2021 | Year | 04 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 10 | Month | 02 | Day |
Last modified on
| 2021 | Year | 05 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047905
| Research Plan | |
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| Registered date | File name |
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