UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033923 |
|---|---|
| Receipt number | R000038686 |
| Scientific Title | Efficacy trial of ingestion of the developmental code USRP-003 |
| Date of disclosure of the study information | 2018/08/31 |
| Last modified on | 2019/08/30 19:14:13 |
* 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
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
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
kitamura.naoya@kao.com
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）、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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038686
