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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038288
Receipt No. R000043643
Scientific Title Comparison of vibegron and mirabegron in the treatment of female over active bladder subjects: A randomized, prospective study
Date of disclosure of the study information 2019/12/01
Last modified on 2019/11/09

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Basic information
Public title Comparison of vibegron and mirabegron in the treatment of female over active bladder subjects: A randomized, prospective study
Acronym Comparative study in vibegron and mirabegron
Scientific Title Comparison of vibegron and mirabegron in the treatment of female over active bladder subjects: A randomized, prospective study
Scientific Title:Acronym Comparative study in vibegron and mirabegron
Region
Japan

Condition
Condition overactive bladder
Classification by specialty
Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to compare the efficacy of vibegron and mirabegron in the treatment of female overactive bladder subjects
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes the change of urgency incontinence, daytime urinary frequency, nocturia between vibegron and mirabegron
Key secondary outcomes th change of OABSS, ICIQ-SF, IPSS and KHQ

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 the intervention of vibegron as the treatment of overactive bladder
Interventions/Control_2 the intervention of mirabegron as the treatment of overactive bladder
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

Not applicable
Gender Female
Key inclusion criteria total OAB symptom scores (OABSS) of>3, urinary urgency episodes>2 per week, post-menopausal women, and age>50 years.
Key exclusion criteria Patients were excluded if they received oral anticholinergic agents, alpha1-blockers, antidepressants, or anti-anxiety agents, had obvious neurogenic bladder dysfunction, bladder calculi, or active urinary tract infection, or had severe cardiac disease, renal dysfunction (serum-creatinine > 2 mg/dL), and/or hepatic dysfunction (i.e., aspartate aminotransferase and alanine aminotransferase levels of more than twice the normal value)
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Hirotaka
Middle name
Last name Sato
Organization Hokusuikai Kinen Hospital
Division name department of urology
Zip code 3100035
Address 3-2-1, Higashihara-cyo, Mito-city, Ibaraki-ken
TEL 0293033003
Email hirotakasato911@yahoo.co.jp

Public contact
Name of contact person
1st name Hirotaka
Middle name
Last name Sato
Organization Hokusuikai Kinen Hospital
Division name department of urology
Zip code 3100035
Address 3-2-1, Higashiha-cyo, Mito-city, Ibaraki-ken
TEL 0293033003
Homepage URL
Email hirotakasato911@yahoo.co.jp

Sponsor
Institute Department of urology, Hokusuikai Kinen Hospital
Institute
Department

Funding Source
Organization Department of urology, Hokusuikai Kinen 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 Hokusuikai Kinen Hospital
Address 3-2-1, Higashihara-cyo, Mito-city, Ibaraki-ken
Tel 0293033003
Email kfujidr-hsk@yahoo.co.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
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 Preinitiation
Date of protocol fixation
2019 Year 09 Month 01 Day
Date of IRB
2019 Year 10 Month 03 Day
Anticipated trial start date
2019 Year 12 Month 01 Day
Last follow-up date
2020 Year 12 Month 31 Day
Date of closure to data entry
2021 Year 01 Month 31 Day
Date trial data considered complete
2021 Year 01 Month 31 Day
Date analysis concluded
2021 Year 02 Month 28 Day

Other
Other related information

Management information
Registered date
2019 Year 10 Month 14 Day
Last modified on
2019 Year 11 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043643

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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