UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027062
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
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)

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
URL(English) https://upload.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


Contact us.