UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012869
Receipt number R000013843
Scientific Title Safety and efficacy of mirabegron on nocturia and quality of sleep in Japanese patients with overactive bladder.
Date of disclosure of the study information 2014/01/16
Last modified on 2014/01/16 12:06:31

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Basic information

Public title

Safety and efficacy of mirabegron on nocturia and quality of sleep in Japanese patients with overactive bladder.

Acronym

Efficacy of mirabegron on nocturia and sleep disorder in Japanese patients with overactive bladder.

Scientific Title

Safety and efficacy of mirabegron on nocturia and quality of sleep in Japanese patients with overactive bladder.

Scientific Title:Acronym

Efficacy of mirabegron on nocturia and sleep disorder in Japanese patients with overactive bladder.

Region

Japan


Condition

Condition

overactive bladder

Classification by specialty

Urology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Analysis of safetu and efficacy of mirabegron on nocturia and sleep disorder in Japanese patients with overactive bladder.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Phase IV


Assessment

Primary outcomes

evaluation of OABSS at baseline and 12weeks.

Key secondary outcomes

bladder diary
N-QOL
AIS
ESS


Base

Study type


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Mirabegron

Interventions/Control_2


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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1 Male and female patients with overactive bladder.(Q3:2over and OABSS total score:3over)
2 Patients attending physician has determined is reasonable to test participation.
3 The contents of the questionnaire can be understood without the aid of others.
4 Patients who consent in writing.

Key exclusion criteria

1 Patients with a history of hypersensitivity to any component of this drug
2 Patients with severe heart disease /Heart rate increase, etc. have been reported, and Symptoms may be worse.
3 Women suspected of being pregnant and pregnant women
4 nursing woman. /Milk transfer has been observed animal experiments(in rats).In addition, this drug in lactation
When administered to dams, reduced body weight gain and lower survival rates have been observed in the offspring.
5 Severe liver dysfunction patients (Child-Pugh score 10 or more)
6 Patients with propafenone hydrochloride or during flecainide acetate administration during.
7 Some of the urinary tract infection with active or chronic bacterial prostatitis.
8 Patients carried out pelvic radiation therapy
9 patients suspected prostate cancer by digital rectal examination or PSA.
10 Patienst with urethral stricture
11 Other things, the attending physician has determined to be inappropriate

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hitomi Sasaki

Organization

Fujita Health University

Division name

Urology

Zip code


Address

1-98,Dengakugakubo, Kutsukake, Toyake, Aichi

TEL

0562-93-9257

Email

sasakih@fujita-hu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hitomi Sasaki

Organization

Fujita Health University

Division name

Urology

Zip code


Address

1-98, Dengakugakubo, Kutsukake, Toyoake, Aichi

TEL

0562-93-9257

Homepage URL


Email

sasakih@fujita-hu.ac.jp


Sponsor or person

Institute

Fujita Health University

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor

Nagoya Ekisaikai Hospital
Nagoya Memorial Hospital
Minami Seikyo Hospital
Chita city Hospital
Aoyama Hospital
Nakatugawa City Hospital
Shizuoka Red Cross Hospital
Hamamatsu Red Cross hospital
Izumitani Fureai Clinic
Mikawa Clinic

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

2014 Year 01 Month 16 Day


Related information

URL releasing protocol


Publication of results

Partially published


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

2012 Year 09 Month 13 Day

Date of IRB


Anticipated trial start date

2012 Year 10 Month 01 Day

Last follow-up date

2014 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

2014 Year 01 Month 16 Day

Last modified on

2014 Year 01 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013843


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name