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UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000012869
Receipt No. 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

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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
Institute Fujita Health University
Institute
Department

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
URL(English) https://upload.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


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