UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027062
Receipt number R000031020
Scientific Title A study on the effectiveness of USRP002(development code)
Date of disclosure of the study information 2017/04/20
Last modified on 2018/11/05 08:38:39

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Basic information

Public title

A study on the effectiveness of USRP002(development code)

Acronym

A study on the effectiveness of USRP002(development code)

Scientific Title

A study on the effectiveness of USRP002(development code)

Scientific Title:Acronym

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

1st name
Middle name
Last name Takatoshi Murase

Organization

Kao Corporation

Division name

Biological Science Research

Zip code


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

1st name
Middle name
Last name Naoya Kitamura

Organization

Kao Corporation

Division name

Biological Science Research

Zip code


Address

2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN

TEL

0285-68-7458

Homepage URL


Email

kitamura.naoya@kao.co.jp


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


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


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

2017 Year 03 Month 24 Day

Date of IRB


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


Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031020


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name