UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035525 |
|---|---|
| Receipt number | R000040474 |
| Scientific Title | A crossover comparison study on overactive bladder: vibegron versus mirabegron |
| Date of disclosure of the study information | 2019/01/11 |
| Last modified on | 2026/01/16 12:02:27 |
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Basic information
Public title
A crossover comparison study on overactive bladder: vibegron versus mirabegron
Acronym
Comparison of two beta 3-adrenoreceptor agonist
Scientific Title
A crossover comparison study on overactive bladder: vibegron versus mirabegron
Scientific Title:Acronym
Comparison of two beta 3-adrenoreceptor agonist
Region
| Japan |
Condition
Condition
overactive bladder
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the patients preference for vibegron and mirabegron
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
patient preference for the drugs, and the reasons
Key secondary outcomes
Clinical efficacy using with questionnaires
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
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
Vibegron
Interventions/Control_2
Mirabegron
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Male and female patients with OAB symptoms
Key exclusion criteria
Patients who have severe heart and liver dysfunction, pregnant women
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Suetomi |
Organization
Ibaraki Seinan Medical Center Hospital
Division name
Department of Urology
Zip code
3060433
Address
2190 Sakai-machi, Sashima-gun
TEL
0280-87-8111
Hinyouki-suetomi@seinan-mch.or.jp
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Suetomi |
Organization
Ibaraki Seinan Medical Center Hospital
Division name
Department of Urology
Zip code
3060433
Address
2190 Sakai-machi, Sashima-gun
TEL
0280-87-8111
Homepage URL
Hinyouki-suetomi@seinan-mch.or.jp
Sponsor or person
Institute
Ibaraki Seinan Medical Center Hospital
Institute
Department
Personal name
Funding Source
Organization
Ibaraki Seinan Medical Center Hospital
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
Ibaraki Seinan Medical Center Hospital
Address
2190 Sakai-machi, Sashima-gun
Tel
0280-87-8111
Hinyouki-suetomi@seinan-mch.or.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
茨城西南医療センター
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 01 | Month | 11 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000040474
Publication of results
Unpublished
Result
URL related to results and publications
not yet
Number of participants that the trial has enrolled
20
Results
We are still in the process of recruiting cases.
Results date posted
| 2024 | Year | 01 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Male and female patients with OAB symptoms.
Participant flow
Outpatient visit, explanation and consent in the outpatient clinic, and obtaining a consent form.
Adverse events
Dry mouth, constipation
Outcome measures
IPSS OABSS NQOL Diary of Urination
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 01 | Month | 11 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 16 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 16 | Day |
Last follow-up date
| 2022 | Year | 01 | 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
| 2019 | Year | 01 | Month | 11 | Day |
Last modified on
| 2026 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040474
