UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019527 |
|---|---|
| Receipt number | R000022585 |
| Scientific Title | Home use test of incontinence pad |
| Date of disclosure of the study information | 2015/10/28 |
| Last modified on | 2015/10/28 09:38:15 |
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Basic information
Public title
Home use test of incontinence pad
Acronym
Home use test of incontinence pad
Scientific Title
Home use test of incontinence pad
Scientific Title:Acronym
Home use test of incontinence pad
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Dermatology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the effect of incontinence pad on the skin
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of the subjects feelings and notes by a dermatologist after using the incontinence pads and the control of the incontinence pads collectively for 11 days
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Use the incontinence pad for 11 days, After washout period, use the placebo pad for 11 days
Interventions/Control_2
Use the placebo pad for 11 days, After washout period, use the incontinence pad for 11 days
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
| 50 | years-old | <= |
Age-upper limit
| 69 | years-old | >= |
Gender
Female
Key inclusion criteria
-Postmenopausal women
-Women with incontinence symptom and care with a pad
-Women with skin trouble in the past
Key exclusion criteria
-Subjects with skin disease such as atopic dermatitis except for rash.
-Pregnancies and lactations
-Subject using the ointment.
-Subjects deemed inappropriate to participate in this study by the doctor in charge.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Koikeda |
Organization
Shiba Palace Clinic
Division name
Shiba Palace Clinic
Zip code
Address
6F, Hamamatsucho, A,Daiwa, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
TEL
03-5408-1599
j_imukyoku@mail.souken-r.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Reiko Maruya |
Organization
SOUKEN Co.,Ltd
Division name
Clinical trial division
Zip code
Address
3F, Hamamatsucho, A,Daiwa, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
TEL
03-5408-1599
Homepage URL
r_maruya@mail.souken-r.com
Sponsor or person
Institute
SOUKEN Co.,Ltd
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
株式会社ＳＯＵＫＥＮ臨床試験室（東京都）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | Month | 28 | 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 | 23 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 08 | Month | 20 | 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 | 10 | Month | 28 | Day |
Last modified on
| 2015 | Year | 10 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022585
