UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study on the effectiveness of USRP002(development code)
Title of the study (Brief title)	A study on the effectiveness of USRP002(development code)
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Urology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	1.To confirm the effectiveness of USRP002(development code) for the urinary functions 2.To investigate the biokinetics of main components and the metabolites in USRP002 (development code)
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Objective indicators on urinary functions after the single intake of USRP002(development code)
Key secondary outcomes	Objective indicators on autonomic nervous activity and components in blood and urine after the single intake of USRP002(development code)

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	4
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	=Evaluation of the effectiveness= -Intake USRP002(development code) -Washout for 1 week -Intake placebo =Analysis of biokinetics= -Washout for 1 week from the evaluation of the effectiveness -Intake USRP002(development code) -Washout for 1 week -Intake placebo
Interventions/Control_2	=Evaluation of the effectiveness= -Intake USRP002(development code) -Washout for 1 week -Intake placebo =Analysis of biokinetics= -Washout for 1 week from the evaluation of the effectiveness -Intake placebo -Washout for 1 week -Intake USRP002(development code)
Interventions/Control_3	=Evaluation of the effectiveness= -Intake placebo -Washout for 1 week -Intake USRP002(development code) =Analysis of biokinetics= -Washout for 1 week from the evaluation of the effectiveness -Intake USRP002(development code) -Washout for 1 week -Intake placebo
Interventions/Control_4	=Evaluation of the effectiveness= -Intake placebo -Washout for 1 week -Intake USRP002(development code) =Analysis of biokinetics= -Washout for 1 week from the evaluation of the effectiveness -Intake placebo -Washout for 1 week -Intake USRP002(development code)
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	59 years-old >=
Gender	Male
Key inclusion criteria	Healthy males
Key exclusion criteria	1.Subjects who attend a hospital or who take drugs 2.Subjects who are always under the weather 3.Subjects who underwent the surgery of urinary functions 4.Subjects who have had brain spinal cord injury, cystitis, vesicoureteral reflux, ureteral stone, prostatitis, urethritis or prostatic hyperplasia 5.Subjects who have had severe diseases 6.Subjects who participated several blood collections in a day within 3 months 7.Subjects who feel bad by blood collection 8.Subjects who use medical equipment such as pacemaker 9.Subjects who has allergy to medical tapes or electrodes 10.Subjects who participate in the other examinations which have an influence on this examination 11.Subjects deemed inappropriate to participate in this study by the principle investigator
Target sample size	15

Research contact person
Name of lead principal investigator	Takatoshi Murase
Organization	Kao Corporation
Division name	Biological Science Research
Address	2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL	0285-68-7871
Email	murase.takatoshi@kao.co.jp

Public contact
Name of contact person	Naoya Kitamura
Organization	Kao Corporation
Division name	Biological Science Research
Address	2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL	0285-68-7458
Homepage URL
Email	kitamura.naoya@kao.co.jp

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
Name of secondary funｄer(s)

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（栃木県）

Other administrative information
Date of disclosure of the study information	2017 Year 04 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 03 Month 24 Day
Anticipated trial start date	2017 Year 04 Month 24 Day
Last follow-up date	2017 Year 07 Month 21 Day
Date of closure to data entry	2018 Year 02 Month 21 Day
Date trial data considered complete	2018 Year 02 Month 21 Day
Date analysis concluded	2018 Year 11 Month 02 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 04 Month 19 Day
Last modified on	2018 Year 11 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031020