UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026582 |
|---|---|
| Receipt number | R000030508 |
| Scientific Title | The verification study for safety evaluation of test food overdose in humans: an open-label trial |
| Date of disclosure of the study information | 2018/03/17 |
| Last modified on | 2017/10/10 07:44:08 |
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Basic information
Public title
The verification study for safety evaluation of test food overdose in humans: an open-label trial
Acronym
The verification study for safety evaluation of test food overdose in humans
Scientific Title
The verification study for safety evaluation of test food overdose in humans: an open-label trial
Scientific Title:Acronym
The verification study for safety evaluation of test food overdose in humans
Region
| Japan |
Condition
Condition
Healthy adults or prone to be constipated
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify the safety of overdose the test food for 4 weeks
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Body measuring / Physical examination
2. Medical examination
3. Blood test
4. Urinalysis
5. Questionnaire (the Likert scale method)
6. The Japanese version of Constipation Assessment Scale MT version (CAS-MT)
7. Bowel movement diary
8. Dental examination
*Above 1-6, conduct examinations and tests at 0 week and at 2 and 4 weeks after the ingestion and at follow-up period 2 weeks
*Above 7, record when defecating
*Above 8, conduct examinations at 0 week and at follow-up period 2 weeks
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
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Duration: 4 weeks
Follow-up duration: 2 weeks
Eat six of test foods per day any time
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Japanese adults
2. Those who are healthy or who have 2-5 times of defecation per week
3. Those who are considered as appropriate for the study by the physician and dentist
Key exclusion criteria
1. At least one previous medical history or under the treatment of malignant tumor, heart failure or myocardial infarction
2. Currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension or other chronic diseases
3. Currently taking medicines and/or herbal medicines
4. Those who are allergic to medicines, milk, beans, orange, and/or other food products
5 Those who are pregnant, breast-feeding, and plan to become a pregnant
6. Those who had participated another clinical test for three months when you signed the informed consent form for this trial
7. Others considered as inappropriate for the study by the physician
Target sample size
52
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuo YAMAMOTO |
Organization
ORTHOMEDICO Inc.
Division name
CEO
Zip code
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.
TEL
03-3818-0610
kazu@orthomedico.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoko SUZUKI |
Organization
ORTHOMEDICO Inc.
Division name
R&D Department
Zip code
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.
TEL
03-3818-0610
Homepage URL
nao@orthomedico.jp
Sponsor or person
Institute
ORTHOMEDICO Inc.
Institute
Department
Personal name
Funding Source
Organization
KANRO CO.,LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Seishin-kai Medical Association Inc, Takara Medical Clinic.
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
医療法人社団 盛心会 タカラクリニック (東京都)
Seishin-kai Medical Association Inc, Takara Medical Clinic (Tokyo)
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 03 | Month | 17 | 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
| 2017 | Year | 03 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 03 | Month | 17 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 03 | Month | 16 | Day |
Last modified on
| 2017 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030508
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
