UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032743
Receipt number R000037344
Scientific Title A verification study of the influence for cognitive and physical functions by using the sanitary products four consecutive weeks
Date of disclosure of the study information 2018/05/30
Last modified on 2020/10/09 11:30:00

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Basic information

Public title

A verification study of the influence for cognitive and physical functions by using the sanitary products four consecutive weeks

Acronym

A verification study of the influence for cognitive and physical functions by using the sanitary products four consecutive weeks

Scientific Title

A verification study of the influence for cognitive and physical functions by using the sanitary products four consecutive weeks

Scientific Title:Acronym

A verification study of the influence for cognitive and physical functions by using the sanitary products four consecutive weeks

Region

Japan


Condition

Condition

Not applicable

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the influence on cognitive and physical functions by using the sanitary products those are suitable for individual subjects for four consecutive weeks.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

(1)Evaluation of cognitive function
(2)Evaluation of physical function

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is 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

During 4 weeks of first term, using sample products (one of pants type or napkin type). Then visit the clinic, answer the questionnaires and questions, measurement of central nervous system and physical functions. During 4 weeks of second term, using control products. Then visit the clinic, answer the questionnaires and questions, measurement of central nervous system and physical functions.

Interventions/Control_2

During 4 weeks of first term, using control products. Then visit the clinic, answer the questionnaires and questions, measurement of central nervous system and physical functions. During 4 weeks of second term, using sample products (one of pants type or napkin type). Then visit the clinic, answer the questionnaires and questions, measurement of central nervous system and physical functions.

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


Not applicable

Gender

Male and Female

Key inclusion criteria

(1) Male and Females aged over 20 years old when informed consent.
(2) Subjects who are usually using or have experience of using the sanitary products such as pad for light incontinence or adult diapers.
(3) Even whether using or not sanitary products, subjects who dirty their wear and/or underwear due to incontinence or subjects who have had incontinence symptoms before.
(4) Subjects who show understanding of the clinical study procedures and agreement with participating the study by written informed consent prior to the study.

Key exclusion criteria

(1)Subjects who have been determined ineligible by the investigator of this clinical test.

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Yukihiro
Middle name
Last name Yada

Organization

University of Tsukuba
School of Integrative

Division name

Global Majors

Zip code

305-8577

Address

1-1-1 Tennodai, Tsukuba, Ibaraki 305-8577 Japan

TEL

029-853-7344

Email

yada.yukihiri.gb@u.tsukuba.ac.jp


Public contact

Name of contact person

1st name Makoto
Middle name
Last name Ichinohe

Organization

CPCC Company Limited

Division name

Planning & Sales Department

Zip code

101-0047

Address

4F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN

TEL

03-5297-3112

Homepage URL


Email

cpcc-contact@cpcc.co.jp


Sponsor or person

Institute

University of Tsukuba
School of Integrative

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

Institutional Review Board of Chiyoda Paramedical Care Clinic

Address

2F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN

Tel

03-5297-5548

Email

IRB@cpcc.co.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

2018 Year 05 Month 30 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 04 Month 20 Day

Date of IRB


Anticipated trial start date

2018 Year 05 Month 31 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

2018 Year 05 Month 28 Day

Last modified on

2020 Year 10 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037344


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name