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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035525
Receipt No. 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 2019/01/11

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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
Middle name
Last name Takahiro Suetomi
Organization Ibaraki Seinan Medical Center Hospital
Division name Department of Urology
Zip code
Address 2190 Sakai-machi, Sashima-gun
TEL 0280-87-8111
Email Hinyouki-suetomi@seinan-mch.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takahiro Suetomi
Organization Ibaraki Seinan Medical Center Hospital
Division name Department of Urology
Zip code
Address 2190 Sakai-machi, Sashima-gun
TEL 0280-87-8111
Homepage URL
Email Hinyouki-suetomi@seinan-mch.or.jp

Sponsor
Institute Ibaraki Seinan Medical Center Hospital
Institute
Department

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
Address
Tel
Email

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 01 Month 11 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 Preinitiation
Date of protocol fixation
2019 Year 01 Month 11 Day
Date of IRB
Anticipated trial start date
2019 Year 01 Month 16 Day
Last follow-up date
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
2019 Year 01 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040474

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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