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
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
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
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
