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
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
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
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
