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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040612
Receipt No. 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 2020/06/01

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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 5
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 Apply the physical therapy 2 for once a day
Interventions/Control_4 Apply the physical therapy 3 for once a day
Interventions/Control_5 Apply the physical therapy 4 for once a day
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 55

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
Institute Kao Corporation
Institute
Department

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
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 Preinitiation
Date of protocol fixation
2020 Year 06 Month 20 Day
Date of IRB
2020 Year 06 Month 20 Day
Anticipated trial start date
2020 Year 07 Month 01 Day
Last follow-up date
2021 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
2020 Year 06 Month 01 Day


Link to view the page
URL(English) https://upload.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


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