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 2023/01/29 20:25:23

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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

Email

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


Email

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

Email

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


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

Enrolling by invitation

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

2023 Year 01 Month 29 Day



Link to view the page

Value
https://center6.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