UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038636 |
|---|---|
| Receipt number | R000044026 |
| Scientific Title | Clinical outcome of beta3 agonists, Mirabegron and Vibegron sequential therapy for overactive bladder(OAB) |
| Date of disclosure of the study information | 2019/12/01 |
| Last modified on | 2024/12/20 19:32:59 |
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Basic information
Public title
Clinical outcome of beta3 agonists, Mirabegron and Vibegron sequential therapy for overactive bladder(OAB)
Acronym
OAB beta3 agonists sequential therapy
Scientific Title
Clinical outcome of beta3 agonists, Mirabegron and Vibegron sequential therapy for overactive bladder(OAB)
Scientific Title:Acronym
OAB beta3 agonists sequential therapy
Region
| Japan |
Condition
Condition
Overactive bladder
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Evaluation of beta3 agonists sequential therapy
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
change of OABSS after 8 week initial beta3 agonist therapy and change of OABSS after 8 week beta3 agonist sequential therapy
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Initially treated with 50mg Mirabegron for 2months and switched to 50mg Vibegron for 2months
Interventions/Control_2
Initially treated with 50mg Vibegron for 2months and switched to 50mg Mirabegron for 2months
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who fit the following criteria
1) chief complaint is urinary urgency
2) OABSS total score is more than 3 and Q3 is more than 2
3) accepted with written consent
Key exclusion criteria
1) Urgency due to bladder infection,urinary malignancies
2) patients who is not available for beta3 agonist treatment
3) deny attending this clinical research
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shunsuke |
| Middle name | |
| Last name | Tsuzuki |
Organization
Jikei University school of medicine
Division name
Department of Urology
Zip code
105-8461
Address
3-25-8 Nishishinbashi Minato-ku Tokyo Japan
TEL
03-3433-1111
tsuzushun60@gmail.com
Public contact
Name of contact person
| 1st name | Shunsuke |
| Middle name | |
| Last name | Tsuzuki |
Organization
Jikei University school of medicine
Division name
Department of Urology
Zip code
105-8461
Address
3-25-8 Nishishinbashi Minato-ku Tokyo Japan
TEL
03-3433-1111
Homepage URL
tsuzushun60@gmail.com
Sponsor or person
Institute
Jikei University school of medicine
Institute
Department
Personal name
Funding Source
Organization
Jikei University school of medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The ethic committee office, Jikei University school of medicine
Address
3-25-8 Nishishinbashi Minato-ku Tokyo Japan
Tel
03-3433-1111
jikei@esct.bvits.com
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
| 2019 | Year | 12 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 11 | Month | 11 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 11 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 11 | Month | 19 | Day |
Last modified on
| 2024 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044026
