UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018429 |
|---|---|
| Receipt number | R000021337 |
| Scientific Title | A Study on the easiness to wear adult diaper |
| Date of disclosure of the study information | 2015/07/27 |
| Last modified on | 2016/09/28 09:31:33 |
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Basic information
Public title
A Study on the easiness to wear adult diaper
Acronym
A Study on the easiness to wear adult diaper
Scientific Title
A Study on the easiness to wear adult diaper
Scientific Title:Acronym
A Study on the easiness to wear adult diaper
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the easiness to wear adult diaper by motion analysis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of the subjects feelings and wearing motion compared with underwear
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
| Other |
Interventions/Control_1
I. Put on and take off an adult diaper on spats in sitting position and in standing position. This is performed repeatedly using 8 kinds of diaper.
II. Put on an adult diaper on spats and walk for 1 min. This is performed repeatedly using 8 kinds of 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
| 65 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy.
A person who has waist size in the range of 60-85cm.
A person who has no use experience of adult diaper.
Key exclusion criteria
A person who has a bad habit with knee.
A Smoker.
A person who usually take some drugs which act on semicircular canals such as a sleeping pill or a headache medicine.
There is a person who has working experience at competitors in oneself or the living family.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenji Andou |
Organization
Kao Corporation
Division name
R&D-Development Research-Sanitary Products Research
Zip code
Address
2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL
0285-68-7433
ando.kenji@kao.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeshi Miyamura |
Organization
Kao Corporation
Division name
R&D-Development Research-Sanitary Products Research
Zip code
Address
2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL
0285-68-7433
Homepage URL
miyamura.takeshi@kao.co.jp
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
Organization
Division
Category of Funding Organization
Self funding
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
花王株式会社ヘルスケアリサーチセンター（東京都）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 07 | Month | 27 | 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
| 2015 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 28 | 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
| 2015 | Year | 07 | Month | 27 | Day |
Last modified on
| 2016 | Year | 09 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021337
| 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 |
