UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy trial of ingestion of the developmental code USRP-003
Acronym	Efficacy trial of ingestion of the developmental code USRP-003
Scientific Title	Efficacy trial of ingestion of the developmental code USRP-003
Scientific Title:Acronym	Efficacy trial of ingestion of the developmental code USRP-003
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of developmental code USRP-003 on the urination in sleep, in healthy men and women.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Efficacy of the 4 weeks ingestion of the developmental code USRP-003 on the number of urination and so on in sleep.
Key secondary outcomes

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	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Daily ingestion of four sugar-coated USRP-003 pills at bed time for 4 weeks. After about 4 weeks washout period, daily ingestion of four sugar-coated placebo pills at bed time for 4 weeks.
Interventions/Control_2	Daily ingestion of four sugar-coated placebo pills at bed time for 4 weeks. After about 4 weeks washout period, daily ingestion of four sugar-coated USRP-003 pills at bed time for 4 weeks.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	50 years-old <=
Age-upper limit	69 years-old >=
Gender	Male and Female
Key inclusion criteria	-Healthy men and women -Subjects who have urination more than twice in sleep
Key exclusion criteria	-Subjects with severe illness -Subjects who take one of the medicine of urinary, sleep and mental disorder -Subjects who have had one of the diseases of brain injury, spinal cord injury, urinary disorder, sleep disorder and mental disorder -Subjects who underwent the surgery of urinary functions -Subjects who drink water over 3L a day -Subjects who regularly take supplements related to urination, sleep or stress -Subjects who have allergy to foods or medicine -Subjects who have menstruation -Subjects who have an unsteady lifestyle -Subjects who have bad condition -Subjects who participate in the other examinations which have an influence on this examination -Subjects judged inappropriate to participate in this study by the principle investigator
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Middle name Last name Naoki Yamamoto
Organization	Kao Corporation
Division name	Biological Science Research
Zip code
Address	2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL	+81-285-68-7468
Email	yamamoto.naoki@kao.com

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	+81-285-68-7458
Homepage URL
Email	kitamura.naoya@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
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）、株式会社シー・エンド・シー（東京都）

Other administrative information
Date of disclosure of the study information	2018 Year 08 Month 31 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	2018 Year 08 Month 31 Day
Date of IRB	2018 Year 08 Month 31 Day
Anticipated trial start date	2018 Year 09 Month 02 Day
Last follow-up date	2019 Year 07 Month 24 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2019 Year 07 Month 24 Day

Other
Other related information

Management information
Registered date	2018 Year 08 Month 28 Day
Last modified on	2019 Year 08 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038686