UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019736
Receipt number R000022671
Scientific Title The examination of the efficacy by adverse reaction changing the treatment with Oxybutynin or Mirabegron on the patient who cannot go on treatment with anticholinergic agent
Date of disclosure of the study information 2015/11/10
Last modified on 2020/05/29 09:28:08

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Basic information

Public title

The examination of the efficacy by adverse reaction changing the treatment with Oxybutynin or Mirabegron on the patient who cannot go on treatment with anticholinergic agent

Acronym

The examination of the efficacy by adverse reaction changing the treatment with Oxybutynin or Mirabegron on the patient who cannot go on treatment with anticholinergic agent

Scientific Title

The examination of the efficacy by adverse reaction changing the treatment with Oxybutynin or Mirabegron on the patient who cannot go on treatment with anticholinergic agent

Scientific Title:Acronym

The examination of the efficacy by adverse reaction changing the treatment with Oxybutynin or Mirabegron on the patient who cannot go on treatment with anticholinergic agent

Region

Japan


Condition

Condition

Overactive bladder

Classification by specialty

Urology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

the efficacy of the changing medicine

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

satisfaction of the patient

Key secondary outcomes

IPSS,OABSS


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are 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

using oxybutynin for 12 weeks

Interventions/Control_2

usin mirabegron for 12 weeks

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

want to change the midicine by adverse reaction

Key exclusion criteria

contraindication of the medicine
acute urinary retension within 12 months
residual urine over 100mL
urinary infection
a1 blacker within 4 weeks

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Akihiro
Middle name
Last name Kawauchi

Organization

Shiga Uneversity of medical science

Division name

Urology

Zip code

5202192

Address

Setatsukinowacho Otsu Shiga

TEL

0775482273

Email

tsuru-sig@umin.ac.jp


Public contact

Name of contact person

1st name Teruhiko
Middle name
Last name Tsuru

Organization

Shiga University of medical Science

Division name

Urology

Zip code

5202192

Address

Setatsukinowacho Otsu Shiga

TEL

0775482273

Homepage URL


Email

tsuru@belle.shiga-med.ac.jp


Sponsor or person

Institute

Department of Urology, Shiga University of medical science

Institute

Department

Personal name



Funding Source

Organization

Self funding

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

Shiga University of medical science

Address

Setatsukinowacho Otsu Shiga

Tel

077-548-2273

Email

tsuru-sig@umin.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

2015 Year 11 Month 10 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

15

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

No longer recruiting

Date of protocol fixation

2014 Year 12 Month 22 Day

Date of IRB

2015 Year 11 Month 09 Day

Anticipated trial start date

2015 Year 11 Month 09 Day

Last follow-up date

2025 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

2015 Year 11 Month 10 Day

Last modified on

2020 Year 05 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022671


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name