UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032536 |
|---|---|
| Receipt number | R000037103 |
| Scientific Title | Clinical study of mixture of nobiletin and tangeretin in patients with nocturia |
| Date of disclosure of the study information | 2018/05/10 |
| Last modified on | 2022/11/11 20:28:53 |
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Basic information
Public title
Clinical study of mixture of nobiletin and tangeretin in patients with nocturia
Acronym
NOT-Nocturia study
Scientific Title
Clinical study of mixture of nobiletin and tangeretin in patients with nocturia
Scientific Title:Acronym
NOT-Nocturia study
Region
| Japan |
Condition
Condition
nocturia
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
We evaluate the effect of mixture of nobiletin and tangeretin after 6 weeks treatment in patients with nocturia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change of nocturnal functional bladder capacity
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Mixture 50mg of nobiletin and tangeretin will be orally administered every day, once after dinner for 6 weeks. After a washout period of 2 weeks, the placebo will be orally administered every day, once after dinner for 6 weeks.
Interventions/Control_2
The placebo will be orally administered every day, once after dinner for 6 weeks. After a washout period of 2 weeks, mixture 50mg of nobiletin and tangeretin will be orally administered every day, once after dinner for 6 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients who has to wake at night more than twice for voiding
2)Patients who has a proper comprehension and compliance
3)50 years old or more patients
4)Patients with ECOG PS 0-2
5)Patients who go to a hospital regularly
Key exclusion criteria
1)Patients with polyuria
2)Residual urine volume is more than 200mL
3)Patients with benign prostatic hyperplasia, over active bladder and neurogenic bladder, who need the treatment other than nocturia
4)Any other patients who are regarded as unsuitable for this study by the investigator
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Haruki Ito |
Organization
National Hospital Organization Kyoto Medical Center
Division name
Urology
Zip code
Address
1-1 Fukakusamukaihata-cho, Fusimi-ku, Kyoto-city, 612-8555, Japan
TEL
075-641-9161
haruki@aqua.ocn.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Haruki Ito |
Organization
National Hospital Organization Kyoto Medical Center
Division name
Urology
Zip code
Address
1-1 Fukakusamukaihata-cho, Fusimi-ku, Kyoto-city, 612-8555, Japan
TEL
075-641-9161
Homepage URL
haruki@aqua.ocn.ne.jp
Sponsor or person
Institute
National Hospital Organization Kyoto Medical Center
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 05 | Month | 10 | 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 | 03 | Month | 19 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 19 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 07 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 05 | Month | 09 | Day |
Last modified on
| 2022 | Year | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037103
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| Registered date | File name |
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