UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021297
Receipt number R000024426
Scientific Title The Efficacy of Mirabegron on Sleep Quality in Japanese patients with nocturia associated overactive bladder
Date of disclosure of the study information 2016/03/02
Last modified on 2018/02/26 17:08:30

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Basic information

Public title

The Efficacy of Mirabegron on Sleep Quality in Japanese patients with nocturia associated overactive bladder

Acronym

The Efficacy of Mirabegron on Sleep Quality

Scientific Title

The Efficacy of Mirabegron on Sleep Quality in Japanese patients with nocturia associated overactive bladder

Scientific Title:Acronym

The Efficacy of Mirabegron on Sleep Quality

Region

Japan


Condition

Condition

Overactive Bladder

Classification by specialty

Urology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Analysis of efficacy of mirabegron for 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

Not applicable


Assessment

Primary outcomes

changes of 12weeks from baseline in OABSS

Key secondary outcomes

changes of 12 weeks from baseline in the following items.
bladder diary, Questionnaire(IPSS, N-QOL, PSQI)
parameters measured with Actiwatch


Base

Study type

Interventional


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
12 weeks
50mg
once a day

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

Female

Key inclusion criteria

1 Female patients with overactive bladder.(OABSS>2 and Q3>1)
2 Patients whom attending physician has determined to be reasonable for 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 who does not consent to this study.
(2) Patients with retention within 12 months.
(3)Patients whose residual urinary volume is more than 100 ml.
(4) Patients with apparent neurogenic bladder.
(5)Patients with bladder disease (bladder cancer, bladder stone, interstitial cystitis etc)
(6)Patients with disease around bladder(endometriosis)
(7)Patients with urinary tract infection, urinary calculus.
(8)Patients with nycturia.
(9)Patients with sleep disorder except the one with nycturia (sleep apnea syndrome, etc).
(10) Patients with mental disorder.
(11) Patients prescribed narcoleptic or medicine for mental disease.
(12)Patients with difficulty in answering the questionnaire without the aid of others.
(13)Patients under treatment with placement of catheter of intermittent self-catheterization.
(14)Patients with circadia rhythm disorder, sift workers, an unsettled lifestyle.
(15)Patients with uncontrollable angle-closure glaucoma
(16)Patient with contraindications to mirabegron(with a history of hypersensitivity to mirabegron, with severe heart disease, on medication with anti-arrhythmics, such as flecainide acetate or propafenone hydrochloride, with long QT syndrome, with difficult-to-control hypertension, with urination difficulty, with severe liver or renal dysfunction)
(17)Patients considered as ineligible for this study by the investigator for other reasons

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yukihiro Kondo

Organization

Nippon Medical School

Division name

Department of Urology

Zip code


Address

1-1-5 Sendagi, Bunkyo-ku, Tokyo Japan

TEL

03-3822-2131

Email

kondoy@nms.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yuka Toyama

Organization

Nippon Medical School

Division name

Department of Urology

Zip code


Address

1-1-5 Sendagi, Bunkyo-ku, Tokyo Japan

TEL

0338222131

Homepage URL


Email

s4036@nms.ac.jp


Sponsor or person

Institute

Nippon Medical School

Institute

Department

Personal name



Funding Source

Organization

Astellas Pharma Inc.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


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

2016 Year 03 Month 02 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

Completed

Date of protocol fixation

2015 Year 12 Month 01 Day

Date of IRB


Anticipated trial start date

2016 Year 02 Month 01 Day

Last follow-up date

2018 Year 01 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

2016 Year 03 Month 02 Day

Last modified on

2018 Year 02 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024426


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name