UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046981 |
|---|---|
| Receipt number | R000053581 |
| Scientific Title | Study of the effect of intake of test supplement on urinary voiding in men: A randomized, double blind, and parallel group comparison study |
| Date of disclosure of the study information | 2023/03/31 |
| Last modified on | 2023/05/16 11:55:39 |
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Basic information
Public title
Study of the effect of intake of test supplement on urinary voiding in men: A randomized, double blind, and parallel group comparison study-
Acronym
Study of the effect of intake of test supplement on urinary voiding in men
Scientific Title
Study of the effect of intake of test supplement on urinary voiding in men: A randomized, double blind, and parallel group comparison study
Scientific Title:Acronym
Study of the effect of intake of test supplement on urinary voiding in men
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the efficacy on urinary voiding and safety of intake of test supplement for 12 consecutive weeks, using placebo as a control.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Bladder diary (urinary frequency, urine volume)
Key secondary outcomes
OAB-q, OABSS-Bother, IPSS-Bother, Pittsburgh sleep quality index-Japanese version (PSQI-J), urinary 8-OHdG
Subgroup analysis of primary and secondary outcome based on urinary frequency, nocturia, urinary 8-OHdG, or PSQI-J
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of test supplement for 12 consecutive weeks
Interventions/Control_2
Intake of placebo for 12 consecutive 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
| 30 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male
Key inclusion criteria
(1) Japanese male from 30 to 80 years of age
(2) Subjects who have problems with urinary voiding (urinary frequency more than 8 times during the day)
Key exclusion criteria
1) Subjects who are judged to have overactive bladder
2) Subjects diagnosed as having benign prostatic hyperplasia.
3) Subjects with a history of prostate cancer or suspected prostate cancer
4) Subjects who have nocturia more than twice in the bladder diary before start of intake of trial supplement
5) Subjects whose PSA is 4.0 ng/mL or higher
6) Subjects who are undergoing hospitalization/treatment for dysuria, or those who have been judged to require treatments
7) Subjects who are unable to record the urine volume for a designated period
8) Subjects who have urinary tract infection, urinary tract stones, kidney stones, ureteral stones, gallstones, etc.
9) Subjects who are taking health foods, etc. that affect urination at least once a week, or those who wish to take them during the study period
10) Subjects who are currently taking medication or exercise therapy
11) Subjects who have or history diseases such as diabetes, hepatic, renal, or cardiac diseases, or diseases that affect the secretion of adrenal cortical hormones, or other metabolic diseases
12) Subjects who have a disease that requires constant medication, those who have a disease under treatment, those who have a history of serious disease, and those who are scheduled for surgery.
13) Subjects who may develop allergies in relation to the research.
14) Subjects who have participated in other clinical trials within the past month prior to the screening test date.
15) Subjects who have had abnormalities in clinical laboratory values or cardiopulmonary function, and are judged to have a problem participating in the study
16) Subjects whose physical measurements, physical examination values, and clinical examination values were significantly out of the reference range
17) Subjects who are judged to be unsuitable as subjects based on the background survey.
18) Subjects who are judged to be unsuitable as subjects by the principal investigator or the principle investigational doctor.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Sayuri |
| Middle name | |
| Last name | Matsuoka |
Organization
FANCL Corporation
Division name
Research Institute, Health science research center
Zip code
244-0805
Address
12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa
TEL
045-820-3449
matsuoka@fancl.co.jp
Public contact
Name of contact person
| 1st name | Kaori |
| Middle name | |
| Last name | Yoshimura |
Organization
EP Mediate Co., Ltd.
Division name
R&D Support Center Foods Department Trial Planning Section
Zip code
162-0821
Address
Kagurazaka AK Bldg., 1-8 Tsukudocho, Shinjuku-ku, Tokyo, 162-0821, Japan
TEL
080-1193-3234
Homepage URL
yoshimura.kaori265@eps.co.jp
Sponsor or person
Institute
EP Mediate Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
FANCL 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
Medical Station Clinic Research Ethics Committee
Address
3-12-8, Takaban, Meguroku, Tokyo
Tel
03-6452-2712
nakagawa.akiko297@eps.co.jp
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
神楽坂泌尿器科クリニック(東京都)、メディカルステーションクリニック(東京都)
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 03 | 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
80
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
| 2022 | Year | 01 | Month | 28 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 28 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 22 | Day |
Last follow-up date
| 2022 | Year | 10 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 02 | Month | 22 | Day |
Last modified on
| 2023 | Year | 05 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053581
