UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035368 |
|---|---|
| Receipt number | R000040304 |
| Scientific Title | A diaper wearing test C01 |
| Date of disclosure of the study information | 2018/12/26 |
| Last modified on | 2020/10/07 16:40:46 |
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Basic information
Public title
A diaper wearing test C01
Acronym
A diaper wearing test
Scientific Title
A diaper wearing test C01
Scientific Title:Acronym
A diaper wearing test
Region
| Japan |
Condition
Condition
Healthy infants
Classification by specialty
| Not applicable | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Motion analysis of an infant wearing a diaper
Basic objectives2
Others
Basic objectives -Others
Analysis of motion of an infant wearing some diapers one of some types of diapers.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Motion analysis of an infant wearing a diaper
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
1.Putting motion analysis markers and EMG sensors on skin
2.Perform the specified operation in the specified area with one of three types of diapers and without diaper.
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
| 12 | months-old | <= |
Age-upper limit
| 30 | months-old | > |
Gender
Male and Female
Key inclusion criteria
1.Healthy male and female infants (12 months to 30 months old)
2.Infants who live in the vicinity of Tokyo and can visit the test site with parental authority.
3.Body weight ; 9 ~ 14kg
4.Infants who can stand or walk alone.
5.Infants who use L size pants-type diaper.
Key exclusion criteria
1.Infants with chronic sickness.
2.Infants who have a severe skin trouble.
3.Infants who have an infective disease.
4.Infants who dislike measurement excessively.
5.Infants who are prone to get rash due to adhesion.
6.Parental authority is occupation of the target infant corresponds in the following.
-Market Research/Marketing department of the manufacturer/Advertising agency
-TV/Radio/Newspaper/Magazine media related
-Specialty stores of baby goods(excluding part-time job)
-Retail stores/Wholesalers/Distribution/Sales relations/sanitary products such as papermaking, paper processed products,sanitary products,diapers,etc.
7.Infants who are judged as a unsuitable test participant by the test staff.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuyuki Okuda |
Organization
Kao Corporation
Division name
Sanitary Products Research
Zip code
Address
2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL
0285-68-7432
okuda.yasuyuki@kao.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kyoko Tsuge |
Organization
Kao Corporation
Division name
Sanitary Products Research
Zip code
Address
2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL
0285-68-7379
Homepage URL
tsuge.kyoko@kao.com
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
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
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
花王株式会社（東京都）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 12 | Month | 26 | 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
| 2018 | Year | 11 | Month | 29 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 29 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 19 | Day |
Last follow-up date
| 2019 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2020 | Year | 10 | Month | 05 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 12 | Month | 26 | Day |
Last modified on
| 2020 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040304
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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