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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034720
Receipt No. R000039586
Official scientific title of the study 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 2018/10/31

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Basic information
Official scientific title of the study Randomized cross-over study of mirabegron and vibegron in female overactive bladder
Title of the study (Brief title) 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 Naoki Wada
Organization Asahikawa Medical University
Division name Department of Renal and Urologic Surgery
Address 2-1 Higashi Midorigaoka Asahikawa
TEL 0166-68-2533
Email nwada@asahikawa-med.ac.jp

Public contact
Name of contact person Naoki Wada
Organization Asahikawa Medical University
Division name Department of Renal and Urologic Surgery
Address 2-1 Higashi Midorigaoka Asahikawa
TEL 0166-68-2533
Homepage URL
Email nwada@asahikawa-med.ac.jp

Sponsor
Institute Asahikawa Medical University
Institute
Department

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)

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

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 11 Month 01 Day
Anticipated trial start date
2019 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 10 Month 31 Day
Last modified on
2018 Year 10 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039586

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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