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UMIN-CTR Clinical Trial |
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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 |
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
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Scientific Title | Safety evaluation test for 4-week continuous intake of foods containing SNR14 in healthy volunteers
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Scientific Title:Acronym | Safety evaluation test for 4-week continuous intake of foods containing SNR14 in healthy volunteers
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Region |
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Condition | ||
Condition | Healthy Volunteer | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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. |
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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. |
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Target sample size | 48 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |