UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034720 |
|---|---|
| Receipt number | R000039586 |
| Scientific Title | Randomized cross-over study of mirabegron and vibegron in female overactive bladder |
| Date of disclosure of the study information | 2018/12/01 |
| Last modified on | 2024/05/07 12:54:05 |
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Basic information
Public title
Randomized cross-over study of mirabegron and vibegron in female overactive bladder
Acronym
Comparative study in mirabegron and vibegron
Scientific Title
Randomized cross-over study of mirabegron and vibegron in female overactive bladder
Scientific Title:Acronym
Comparative study in mirabegron and vibegron
Region
| Japan |
Condition
Condition
overactive bladder
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the efficacy and safety of mirabegron and vibegron
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement of OABSS
Key secondary outcomes
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
Female
Key inclusion criteria
Female OAB patients with less than 150ml of postvoid residual
Key exclusion criteria
Patients who have severe liver and heart dysfucntion
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Wada |
Organization
Asahikawa Medical University
Division name
Department of Renal and Urologic Surgery
Zip code
0788510
Address
2-1 Higashi Midorigaoka Asahikawa
TEL
0166-68-2533
nwada@asahikawa-med.ac.jp
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Wada |
Organization
Asahikawa Medical University
Division name
Department of Renal and Urologic Surgery
Zip code
0788510
Address
2-1 Higashi Midorigaoka Asahikawa
TEL
0166-68-2533
Homepage URL
nwada@asahikawa-med.ac.jp
Sponsor or person
Institute
Asahikawa Medical University
Institute
Department
Personal name
Funding Source
Organization
Asahikawa Medical University
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
Asahikawa Medical University
Address
2-1 Higashi Midorigaoka Asahikawa
Tel
0166-68-2533
nwada@asahikawa-med.ac.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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-bin/icdr/ctr_up_reg_f5.cgi
Publication of results
Published
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-bin/icdr/ctr_up_reg_f5.cgi
Number of participants that the trial has enrolled
60
Results
Similar efficacy between Mirabegron and Vibegron
Results date posted
| 2024 | Year | 05 | Month | 07 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Female fresh overactive bladder patients
Participant flow
Registered according to inclusion criteria
Adverse events
Nothing special
Outcome measures
Change of OABSS
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 28 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | 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
| 2018 | Year | 10 | Month | 31 | Day |
Last modified on
| 2024 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039586
