UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039510 |
|---|---|
| Receipt number | R000045052 |
| Scientific Title | Examination on the search for disintegration site of hard capsule in intestine |
| Date of disclosure of the study information | 2020/02/17 |
| Last modified on | 2020/03/02 12:42:43 |
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Basic information
Public title
Examination on the search for disintegration site of hard capsule in intestine
Acronym
Examination on the search for disintegration site of hard capsule in intestine
Scientific Title
Examination on the search for disintegration site of hard capsule in intestine
Scientific Title:Acronym
Examination on the search for disintegration site of hard capsule in intestine
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
For healthy men, the disintegration property of the test food capsule with barium sulfate 150 mg is confirmed by sequential X-ray photography.
Basic objectives2
Others
Basic objectives -Others
Capsule disintegration site and time
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Capsule disintegration site and time are determined by X-ray imaging.
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
Single intake of the test food capsule with contrast agent.
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
| 64 | years-old | >= |
Gender
Male
Key inclusion criteria
Healthy males from 20 to 64 years of age
Key exclusion criteria
(1) Subjects who have constipation or diarrhea every day
(2) Subjects judged as unsuitable for the study by the investigator for other reasons
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Kei |
| Middle name | |
| Last name | Yui |
Organization
FANCL Corporation
Division name
Research Institute, Health science research center
Zip code
244-0806
Address
12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa
TEL
045-820-3443
ke-yui@fancl.co.jp
Public contact
Name of contact person
| 1st name | Saki |
| Middle name | |
| Last name | Fukuchi |
Organization
TC Co.,Ltd.
Division name
Clinical Research Planning Department
Zip code
150-0021
Address
Seibu Shinkin Bank Ebisu Bldg.,1-20-2, Ebisunishi, Shibuya-ku, Tokyo
TEL
03-5459-5329
Homepage URL
s.fukuchi@ttc-tokyo.co.jp
Sponsor or person
Institute
TTC Co.,Ltd.
Institute
Department
Personal name
Funding Source
Organization
FANCL Corporation
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
Tana Orthopedic Surgery Institutional Review Board
Address
15-7 Tanacho, Yokohama Aoba-ku, Kanagawa 227-0064 Japan
Tel
045-989-2225
shimoda_k@kaiseikai-net.or.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
医療法人社団快晴会 北新横浜内科クリニック
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 02 | 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
| 2020 | Year | 02 | Month | 07 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 15 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 17 | Day |
Last follow-up date
| 2020 | Year | 02 | 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
| 2020 | Year | 02 | Month | 17 | Day |
Last modified on
| 2020 | Year | 03 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045052
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
