UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008084 |
|---|---|
| Receipt number | R000009356 |
| Scientific Title | The clinical study of beta 3-agonist (Betanis) for lower urinary tract symptoms mainly for overactive bladder |
| Date of disclosure of the study information | 2012/07/01 |
| Last modified on | 2012/06/01 22:41:14 |
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Basic information
Public title
The clinical study of beta 3-agonist (Betanis) for lower urinary tract symptoms mainly for overactive bladder
Acronym
The clinical study of beta 3-agonist for lower urinary tract symptoms
Scientific Title
The clinical study of beta 3-agonist (Betanis) for lower urinary tract symptoms mainly for overactive bladder
Scientific Title:Acronym
The clinical study of beta 3-agonist for lower urinary tract symptoms
Region
| Japan |
Condition
Condition
lower urinary tract symptoms (overactive bladder)
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will evaluate the efficacy and safety about beta 3-agonist (Betanis), a novel drug for lower urinary tract symptoms mainly for overactive bladder.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
safety, efficiency
Key secondary outcomes
I-PSS, OABSS
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
beta 3-agonist
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) those who are diagnosed as OAB according to the OAB guideline
(2) those who go urination more than 8 times per day, or who go urination more than 2 times at night
(3) those who have incontinence more than 1 time per week
Key exclusion criteria
(1) those who have critical infectious disease or have uncontrollable complications
(2) those who have active urothelial cancer or prostate cancer
(3) those who have critical heart disease
(4) those who have the episode of urinary retention
(5) those who are considered as inappropriate for this study by the responsible doctor
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koji Yoshiura |
Organization
Kyoto University Hospital
Division name
Dept. of Urology
Zip code
Address
Shogoin Kawahara-cho 54, Sakyo, Kyoto
TEL
075-751-3327
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshio Sugino |
Organization
Kyoto University Hospital
Division name
Dept. of Urology
Zip code
Address
Shogoin Kawahara-cho 54, Sakyo, Kyoto
TEL
075-751-3337
Homepage URL
Sponsor or person
Institute
Dept. of Urology, Kyoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Shiga Medical University
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
京都大学医学部附属病院、滋賀医科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 07 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2012 | Year | 05 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 06 | Month | 01 | Day |
Last modified on
| 2012 | Year | 06 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009356
