UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040575 |
|---|---|
| Receipt number | R000046313 |
| Scientific Title | Quality verification testing for identified the location of seamless capsule dissolution in digestive tract. |
| Date of disclosure of the study information | 2020/06/19 |
| Last modified on | 2020/11/30 09:01:29 |
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Basic information
Public title
Quality verification testing for identified the location of seamless capsule dissolution in digestive tract.
Acronym
Quality verification testing for identified the location of seamless capsule dissolution in digestive tract.
Scientific Title
Quality verification testing for identified the location of seamless capsule dissolution in digestive tract.
Scientific Title:Acronym
Quality verification testing for identified the location of seamless capsule dissolution in digestive tract.
Region
| Japan |
Condition
Condition
Not applicable (healthy adults)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Clarify the disintegration site of the seamless capsules.
Basic objectives2
Others
Basic objectives -Others
Performance evaluation of seamless capsules.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Difference the process of the disintegration caused by constitution of seamless capsules.
Key secondary outcomes
Estimation of the transit time in digestive tract.
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Japanese healthy males and females checked by health examination at the company.
(2) Subjects aged, 20 to 50 years old at the informed consent.
(3) Non-pregnant females.
Key exclusion criteria
(1) Subjects who have gastrointestinal disturbance based on questionary at the volunteer recruitment.
(2) Subjects who have potential effect on transit time of digestive tract (Gastrectomy etc).
(3) Subjects who have histories of gastrointestinal ulcer.
(4) Subjects who have disease histories of gastrointestinal tract during a latest month or have symptoms at the volunteer recruitment.
(5) Subjects who have histories of serious illness (Ischemic heart disease etc).
(6) Subjects who have histories of serious cardiac dysfunction or blood abnormalities.
(7) Subjects judged as unsuitable for the study by the investigator for mental illness or behavioral abnormalities.
(8) The pregnant or lactating females.
(9) Subjects who have been determined ineligible by the investigator.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Shunji |
| Middle name | |
| Last name | Fujimori |
Organization
Nippon Medical School Chiba Hokusoh Hospital
Division name
Gastroenterological Medicine
Zip code
270-1694
Address
1715, kamagari, Inzai-City, Chiba
TEL
0476-99-1111
s-fujimori@nms.ac.jp
Public contact
Name of contact person
| 1st name | Mamiko |
| Middle name | |
| Last name | Kohno |
Organization
Morishita Jintan Co., Ltd.
Division name
Health Care Product Department
Zip code
101-0043
Address
Ascend Kanda Building 6F, 10-2, Tomiyama-cho Kanda, Chiyoda-ku, Tokyo
TEL
03-6206-8138
Homepage URL
m_kohno@jintan.co.jp
Sponsor or person
Institute
Nippon Medical School Chiba Hokusoh Hospital
Institute
Department
Personal name
Funding Source
Organization
Morishita Jintan 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
Nippon Medical School Chiba Hokusoh Hospital
Address
1715, kamagari, Inzai-City, Chiba
Tel
0476-99-1111
s-fujimori@nms.ac.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
| 2020 | Year | 06 | Month | 19 | 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
| 2019 | Year | 10 | Month | 21 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 04 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 19 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2020 | Year | 05 | Month | 29 | Day |
Last modified on
| 2020 | Year | 11 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046313
