UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024460 |
|---|---|
| Receipt number | R000028154 |
| Scientific Title | A clinical study for evaluating safety of excessive consumption -Non-blind, safety verification study taking 5 times dose of test food "ECM-E" in healthy adults. |
| Date of disclosure of the study information | 2016/11/01 |
| Last modified on | 2018/04/20 10:07:49 |
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Basic information
Public title
A clinical study for evaluating safety of excessive consumption
-Non-blind, safety verification study taking 5 times dose of test food "ECM-E" in healthy adults.
Acronym
A clinical study for evaluating safety of excessive consumption
-Non-blind, safety verification study taking 5 times dose of test food "ECM-E" in healthy adults.
Scientific Title
A clinical study for evaluating safety of excessive consumption
-Non-blind, safety verification study taking 5 times dose of test food "ECM-E" in healthy adults.
Scientific Title:Acronym
A clinical study for evaluating safety of excessive consumption
-Non-blind, safety verification study taking 5 times dose of test food "ECM-E" in healthy adults.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We verify safety of excessive consumption of "ECM-E" for 4 weeks (by taking 5 times of its normal dose).
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
-Appearance of adverse events
-Height, weight and BMI
-Body temperature, blood pressure and pulse
-12-lead electrocardiogram
-General hematology test
-Blood biochemistry test
-Urinalysis
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake 5 times of normal dose of test food for 28 days, every day
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
| 45 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Target subject must satisfy the following selection criteria.
1) Healthy Japanese aged from 20 to 45 years-old at the time of giving informed consent
2) A person who is not using chronic or seasonal drugs or medical equipment and is not undergoing rehabilitation therapy
3) A person who has freely given informed consent and has fully understood the purpose of the study
4) A person whose BMI is from 18.5 to 30.0
5) When measuring blood pressure twice, a person whose average blood pressure is within a range of followings;
Systolic blood pressure: less than or equal to 139mmHg
Diastolic blood pressure: less than or equal to 89mmHg
6) A person whose pulse rate is from 40 to 100 per minute
7) A person whose body temperature is from 35.5 to 37.0 degree Celsius
8) A person who can prevent from excessive exercise during the study
9) A person who can basically have 3 meals in a day during the study
10) A person who can conduct contraception by appropriate ways during the study
11) A person who understands and follows rules and requirements during the study
12) A person who is considered totally fit for participating the study by a comprehensive judgement of lead principal investigator and others.
Key exclusion criteria
The following exclusion criteria apply to subjects.
1) A person with the disease in gastrointestinal tract, liver, kidney, heart and circulatory system which have an influence on the absorption, distribution, metabolism and excretion of test food
2) A person with a major surgery history in the gastrointestinal tract sites such as gastrectomy, stomach and intestines suture, the intestinal resection (however, polypectomy, the appendectomy are excluded)
3) A person with a history of cerebrovascular disorder (the asymptomatic lacunar infarct is excluded)
4) A person with tattoo which has an influence on the study because of its size or range
5) A person with hypersensitivity or idiosyncrasy, such as food allergy
6) A person who is suspected to have alcohol or drug dependence
7) A person who has participated in other clinical trials within 84 days from giving an informed consent
8) A person who donated 400 ml of blood within 84 days, 200 ml within 28 days, or a blood component (plasma or platelets) within 14 days from giving an informed consent
9) A person who hopes pregnancy or who cannot prevent conception during the study
10) A nursing or pregnant woman
11) A person who is engaged in night duty
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akihito Yoshida |
Organization
MEDOC Medical Dock & Clinic
Division name
internal medicine
Zip code
Address
4-3, Yasudadori, Showa-ku, Nagoya-shi
TEL
052-752-1135
chiken@medoc.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiromichi Hayashi |
Organization
Medeical Fusion Co.,Ltd.
Division name
Clinical development division
Zip code
Address
Nagoya mechanic cooperation incubator, 2-22-8, Chikusa, Chikusa-ku, Nagoya-shi
TEL
052-745-3300
Homepage URL
http://www.m-fusion.co.jp/
info@m-fusion.co.jp
Sponsor or person
Institute
Adaptgen Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Adaptgen Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
医療法人 メドック健康クリニック(愛知県)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 11 | Month | 01 | 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
Completed
Date of protocol fixation
| 2016 | Year | 10 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 10 | Month | 18 | Day |
Last modified on
| 2018 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028154
