UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040612
Receipt number R000046350
Scientific Title A Study on the efficacy of PR-443 for physical effect.
Date of disclosure of the study information 2020/06/30
Last modified on 2023/12/04 14:29:28

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Basic information

Public title

Efficacy test of PR-443 for physical effect.

Acronym

Efficacy test of PR-443 for physical effect.

Scientific Title

A Study on the efficacy of PR-443 for physical effect.

Scientific Title:Acronym

A Study on the efficacy of PR-443 for physical effect.

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To confirm the effect for physiological responses by physical therapy for healthy male

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Evaluation of the kinetic property of a muscle and clinical validation of fatigue feeling after the treatment with PR-443.

Key secondary outcomes

Changes in blood flow, muscle temperature, and blood components after the treatment with PR-443.


Base

Study type

Interventional


Study design

Basic design

Parallel

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

Treatment

Type of intervention

Other

Interventions/Control_1

Apply PR-443 for once a day

Interventions/Control_2

Apply the physical therapy 1 for once a day

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

39 years-old >=

Gender

Male

Key inclusion criteria

Healthy males

Key exclusion criteria

- Subjects with atopic dermatitis, eczema and pollen allergy
- Subjects with hypertension, heart disease, diabetes mellitus and Raynaud's disease
- Subjects deemed inappropriate to participate in this study by the principle investigator

Target sample size

16


Research contact person

Name of lead principal investigator

1st name Yasuo
Middle name
Last name Toyoshima

Organization

Kao Corporation

Division name

Personal Health Care Products Research

Zip code

131-8501

Address

2-1-3, Bunka, Sumida-ku, Tokyo 131-8501, Japan

TEL

03-5630-7281

Email

toyoshima.yasuo@kao.com


Public contact

Name of contact person

1st name Satoru
Middle name
Last name Nariai

Organization

Kao Corporation

Division name

Personal Health Care Products Research

Zip code

131-8501

Address

2-1-3, Bunka, Sumida-ku, Tokyo 131-8501, Japan

TEL

03-5630-7282

Homepage URL


Email

nariai.satoru@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

Japanese Red Cross Hokkaido College of Nursing

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Human Research Ethics Committee, Kao Corporation

Address

2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN

Tel

+81-3-5630-7263

Email

morisaki.naoko@kao.com


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

日本赤十字北海道看護大学(北海道)


Other administrative information

Date of disclosure of the study information

2020 Year 06 Month 30 Day


Related information

URL releasing protocol

None

Publication of results

Unpublished


Result

URL related to results and publications

None

Number of participants that the trial has enrolled

18

Results

Omit the description

Results date posted

2023 Year 12 Month 04 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Omit the description

Participant flow

Omit the description

Adverse events

Omit the description

Outcome measures

Omit the description

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2020 Year 06 Month 20 Day

Date of IRB

2020 Year 06 Month 20 Day

Anticipated trial start date

2021 Year 12 Month 02 Day

Last follow-up date

2022 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 06 Month 01 Day

Last modified on

2023 Year 12 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046350


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name