UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010060 |
|---|---|
| Receipt number | R000011779 |
| Scientific Title | Clinical efficacy and safety of a beta3-adrenoceptor agonist and an antimuscarinic agent in female patients with overactive overactive bladder: a randomized crossover study |
| Date of disclosure of the study information | 2013/02/18 |
| Last modified on | 2016/01/29 20:10:53 |
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Basic information
Public title
Clinical efficacy and safety of a beta3-adrenoceptor agonist and an antimuscarinic agent in female patients with overactive overactive bladder: a randomized crossover study
Acronym
Clinical comparison between miragegron and imidafenacin: a randomized crossover study
Scientific Title
Clinical efficacy and safety of a beta3-adrenoceptor agonist and an antimuscarinic agent in female patients with overactive overactive bladder: a randomized crossover study
Scientific Title:Acronym
Clinical comparison between miragegron and imidafenacin: a randomized crossover study
Region
| Japan |
Condition
Condition
Overactive bladder
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare efficacy and safety between a beta3-adrenoceptor agonist and an antimuscarinic agent
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Change of average urinary frequency for 24 hours
Key secondary outcomes
Change of average urgency frequency for 24 hours, Change of average urinary incontinence frequency for 24 hours, Change of average voided volume, Change of average nocturnal frequency, Change of QOL score, Change of flow rate, Change of post-void residual urine
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Mirabegron (50 mg daily) for 8weeks, wash out for 2 weeks and Imidafenacin (0.2 mg daily) for 8weeks
Interventions/Control_2
Imidafenacin (0.2 mg daily) for 8weeks, wash out for 2 weeks and mirabegron (50 mg daily)
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
In overactive bladder symptom score (OABSS), Q3 (urgency) score is 2 and more, and total score is 3 and more.
Key exclusion criteria
1. Postvoid residual urine 50 mL and more, 2. Active urinary tract infection, 3. Histories of malignant tumors in the lower urinary tract, 4. Histories of surgery for the lower urinary tract in the last 3 months
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazumasa Torimoto |
Organization
Nara Medical University
Division name
Urology
Zip code
Address
840 Shijo-cho, Kashihara, Nara
TEL
0744-22-3051
torimoto@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazumasa Torimoto |
Organization
Nara Medical University
Division name
Urology
Zip code
Address
840 Shijo-cho, Kashihara, Nara
TEL
0744-22-3051
Homepage URL
torimoto@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical University
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
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
| 2013 | Year | 02 | Month | 18 | 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
Completed
Date of protocol fixation
| 2012 | Year | 01 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 01 | Month | 27 | Day |
Last follow-up date
| 2015 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 02 | Month | 18 | Day |
Last modified on
| 2016 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011779
