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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020607
Receipt No. R000023788
Scientific Title Efficacy and long-term safety trials - Double-blind, placebo-controlled, dose-response, parallel-group study using a test food "EMFCTR-01" of the usual dose or the triple dose -
Date of disclosure of the study information 2016/01/18
Last modified on 2017/09/08

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Basic information
Public title Efficacy and long-term safety trials
- Double-blind, placebo-controlled, dose-response, parallel-group study using a test food "EMFCTR-01" of the usual dose or the triple dose -
Acronym Efficacy and long-term safety trials
- Double-blind, placebo-controlled, dose-response, parallel-group study using a test food "EMFCTR-01" of the usual dose or the triple dose -
Scientific Title Efficacy and long-term safety trials
- Double-blind, placebo-controlled, dose-response, parallel-group study using a test food "EMFCTR-01" of the usual dose or the triple dose -
Scientific Title:Acronym Efficacy and long-term safety trials
- Double-blind, placebo-controlled, dose-response, parallel-group study using a test food "EMFCTR-01" of the usual dose or the triple dose -
Region
Japan

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

Objectives
Narrative objectives1 We will check about safety while people take usual or 3times-dose "EMFCTR-01" for 12 weeks.
We evaluated safety through physical examinations (interviews, auscultation, percussion, inspection, palpation, etc.), changes in clinical laboratory values, and diary by subject from the baseline evaluation (vist0) to the third evaluation (visit3) or post evaluation.
Basic objectives2 Others
Basic objectives -Others We evaluated Efficacy of the test food "EMFCTR-01" through the fecal status from the next day after obtaining informed consent to Visit3. Also, we verified the effects of "EMFCTR-01" on other parameters, including organ functionality, through, physical examinations (interview, auscultation, percussion, inspection, palpation, etc.), and changes in clinical laboratory values from the baseline evaluation (visit0) to the third evaluation (visit3) or post evaluation.
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Adverse events
period : from Visit0 to Visit3
Key secondary outcomes -Physical signs, physical symptom, primary disease, complications, anamnesis, history of present illness
-Concomitant medications, adjunctive therapy
-Blood pressure/pulse
-Body temperature
-Height, Weight, Body mass index(BMI)
-12-lead electrocardiogram
-General hematology tests
-Blood biochemistry tests
-Urinalysis -The fecal situation (fecal frequency, fecal volume , fecal property)
-Meal recording
-State of facial skin as examined by Robo Skin Analyzer RSA50.
-State of hair as examined by Mobile Skin Analyzer AOT-ST.
-Blood pressure pulse wave
-Hardness of muscle
-CT examination

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 Numbered container method

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 dosing period : 12 weeks
dose : usual dose ("EMFCTR-01"concentration 11mL/33mL)
frequency : once a day
Interventions/Control_2 dosing period : 12 weeks
dose : 3 times dose 33mL ("EMFCTR-01"concentration 33mL/33mL)
frequency : once a day
Interventions/Control_3 dosing period : 12 weeks
dose : plasebo 33mL ("EMFCTR-01"concentration 0mL/33mL)
frequency : once a day
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
30 years-old <=
Age-upper limit
55 years-old >=
Gender Male and Female
Key inclusion criteria Target subjects must satisfy the following selection criteria.
-Healthy Japanese men and women aged more than 30 years, less than 55 years at the time of giving informed consent.
-A person of Japanese nationality for 20 years.
-A person who, during the screening period, is not using chronic or seasonal drugs or medical equipment, and is not undergoing rehabilitation therapy.
-A person who has freely given consent and has understood the purpose of the study.
-A person whom the tendency of the property of the feces(the score of the property of the feces/days) is less than 2.5 from the next day of the agreement acquisition day to -1 day.
-BMI:18.5 -30.0
-Blood pressure
Systolic blood pressure:less than 159mmHg
Diastolic blood pressure:less than 99mmHg
-Pulse rate:50-100 times/minute
-Body temperature:35.5-37.0 degrees
-Excessive exercise can prevent a person from participating in the clinical study.
-A person who can take three meals a day basically and prohibit great intemperance during the clinical study.
-A person who can conduct contraception by an appropriate way during the clinical study.
-Participant who understands that clinical visits are mandatory during clinical study period.
-A person who are considered fit for the enrollment in the clinical study.
Key exclusion criteria The following exclusion criteria apply to subjects.
-Use of any prescription drugs or any over-the-counter drugs from -7 day to -1 day before dosing.
-A person who have used the steroid drug within the past three months of consent acquisition date.
-A person with diseases of the digestive tract, liver, kidney, heart, and circulatory system that might affect test food absorption, distribution, metabolism, and excretion.
-A person with a lengthy surgical history, including gastrointestinal suture surgery, or intestinal resection. However, polypectomy and appendectomy will not exclude a patient.
-A person with a history of cerebrovascular disease (asymptomatic lacunar infarction is excluded).
-A person with tattoo.
-A person with hypersensitivity or idiosyncrasy, such as food allergies.
-A person with alcohol or drug dependency.
-A person who has participated in other clinical trials within 84 days of giving informed consent.
-A person who has donated 400 ml of blood within 84 days, 200 ml of blood within 28 days, or a blood component (plasma or platelets) within 14 days of giving informed consent.
-The person who hopes for pregnancy or the person who can't prevent conception during the clinical study.
-Nursing or pregnant woman.
-A person whose diagnosis requires treatment of mental illness by a clinical investigator.
-A person who housemate is participating or a plan to participate in this clinical study.
-A person with taking "tenshi no Lara" within the past for 1 year from an agreement acquisition day.
-A women who is postmenopausal
-A person who are engaged in night duty.
-The person doing the hair dyeing, the permanent wave and the frizzled hair correction, etc. which have an influence on a hair and scalp.
-A person who is unable to comply with administrative matters during the clinical study.
-A person who are determined ineligible by the clinical investigator.
Target sample size 45

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hitoshi Yoshida
Organization MEDOC Medical Dock&Clinic
Division name Internal medicine
Zip code
Address 4-3, Yasudadori, Syowa-ku, Nagoya, Aichi, 466-0857, Japan
TEL 052-752-1135
Email chiken@medoc.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiromichi Hayashi
Organization Medical Fusion Co.,Ltd.
Division name Clinical development division
Zip code
Address Nagoya Life Science Incubator, 2-22-8, Chikusa, Chikusa-ku, Nagoya, Aichi, 464-0858, Japan
TEL 052-745-3300
Homepage URL http://www.m-fusion.co.jp/
Email info@m-fusion.co.jp

Sponsor
Institute Medical Fusion Co.,Ltd.
Institute
Department

Funding Source
Organization Eminet 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
Address
Tel
Email

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
2016 Year 01 Month 18 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 01 Month 07 Day
Date of IRB
Anticipated trial start date
2016 Year 02 Month 22 Day
Last follow-up date
2016 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2016 Year 12 Month 27 Day

Other
Other related information

Management information
Registered date
2016 Year 01 Month 17 Day
Last modified on
2017 Year 09 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023788

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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