UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014150 |
|---|---|
| Receipt number | R000016475 |
| Scientific Title | Effect of Mirabegron (beta 3-adrenergic receptor agonist) on overactive bladder patients : a functional brain imaging study |
| Date of disclosure of the study information | 2014/06/16 |
| Last modified on | 2018/02/14 19:43:40 |
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Basic information
Public title
Effect of Mirabegron (beta 3-adrenergic receptor agonist) on overactive bladder patients : a functional brain imaging study
Acronym
Effect of Mirabegron (beta 3-adrenergic receptor agonist) on overactive bladder patients : a functional brain imaging study
Scientific Title
Effect of Mirabegron (beta 3-adrenergic receptor agonist) on overactive bladder patients : a functional brain imaging study
Scientific Title:Acronym
Effect of Mirabegron (beta 3-adrenergic receptor agonist) on overactive bladder patients : a functional brain imaging study
Region
| Japan |
Condition
Condition
Overactive bladder
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
How do treatment with mirabegron inhibit the symptom such as urgency
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison brain image between before- and after-treatment with mirabegron using PET
Key secondary outcomes
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
treatment with 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
Female
Key inclusion criteria
1.Postmenopausal patient
2.Patient who do not wish to have children at all
3.Patient who has an overactive bladder symptom score (OABSS) total score of 3 points and an OABSS Question 3 score of 2 points.
4.Outpatient
5.Pathient who can answer to questionnaires, and can walk to toilet unaided and measuring urine volume by him-/herself.
6.Patient Has personally given written informed consent.
Key exclusion criteria
1.Patient with a history of hypersensitivity to mirabegron
2.Patient with a severe heart disease
[Mirabegron might worsen the heart disease since some adverse reactions such as heart rate elevation by mirabegron have been reported]
3.Patient taking flecainide acetate or propafenone hydrochloride.
4.Patient with long QT syndrome.
5.Patient who is vulnerable to arrhythmia such as bradycardia or acute myocardial ischemia.
6.Patient who has taken anticholinergic drugs to treat OAB less than 3 months before study participation
7.Patients with hypokalemia
8.Patient with uncontrolled hypertension (indicated by a systolic blood pressure [SBP] 180 mm Hg or diastolic blood pressure [DBP] 110 mm Hg measured in a sitting position
9.Patient with severe hepatic impairment
10.Patient with severe renal impairment
11. Patient with glaucoma
12.Patient with urination difficulty
13. Patient with anuresis
14. Patient whose residual urinary volume during the observational period is more than 100 mL
15.Patient with an indwelling catheter or practicing intermittent self-catheterization
16. Patient with polyuria, with the mean daily urine volume >= 40 mL/kg
17. Patient complicates with urinary tract infection, urinary calculus or interstitial cystitis, or who had a history of recurrent urinary tract infection
18.Patient complicates with bladder tumor
19.Patient has been undergone surgical operation that might affect their urinary function within 6 months prior to study participation
20.Patient who has received non-drug therapy such as electrical stimulation (low-frequency therapy and magnetic stimulation, for example), biofeedback procedure, bladder training or pelvic floor muscle exercise within 6 months prior to initiation of the observational period
21.Patient with mood disorder, neurotic disorder or schizophrenia, or with a history of such.
22.Patient who is deemed otherwise unsuitable by the investigator or sub-investigator.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeya Kitta |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Renal and Genitourinary surgery
Zip code
Address
North 15, West 7, Kita-ku, Sapporo, 060-8638, Japan
TEL
011-706-5966
kitta@fb3.so-net.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeya Kitta |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Renal and Genitourinary surgery
Zip code
Address
North 15, West 7, Kita-ku, Sapporo, 060-8638, Japan
TEL
011-706-5966
Homepage URL
kitta@fb3.so-net.ne.jp
Sponsor or person
Institute
Hokkaido University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Astellas Pharma Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
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
北海道大学附属病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 06 | Month | 16 | 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
| 2014 | Year | 03 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 16 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 06 | Month | 03 | Day |
Last modified on
| 2018 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016475
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| Registered date | File name |
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