UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038196 |
|---|---|
| Receipt number | R000043536 |
| Scientific Title | A randomized controlled trial of mirabegran and fesoterodine in overactive bladder |
| Date of disclosure of the study information | 2020/03/01 |
| Last modified on | 2019/10/03 17:57:18 |
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Basic information
Public title
A randomized controlled trial of mirabegran and fesoterodine in overactive bladder
Acronym
A randomized controlled trial of mirabegran and fesoterodine in overactive bladder
Scientific Title
A randomized controlled trial of mirabegran and fesoterodine in overactive bladder
Scientific Title:Acronym
A randomized controlled trial of mirabegran and fesoterodine in overactive bladder
Region
| Japan |
Condition
Condition
overactive bladder
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to compare the efficacy of fesoterodine and mirabegron in the treatment of overactive bladder patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
total score of overactive bladder symptom score
Key secondary outcomes
each score of overactive bladder symptom score, total score of overactive bladder symptom score international prostate symptom score, total score of King's Health Questionnaire, frequency volume chart, urofluometry, residual urine
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
the intervention of fesoterodine as the treatment of overactive bladder
Interventions/Control_2
the intervention of mirabegron as the treatment of overactive bladder
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
total score of overactive bladder symptom score >3, score of question 3 in overactive bladder symptom score >2
Key exclusion criteria
patients with a history of hypersensitivity to fesoterodine or mirabegron
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Tomohiko |
| Middle name | |
| Last name | Kamasako |
Organization
Dokkyo Medical University Hospital
Division name
Department of Urology, Continence Center
Zip code
321-0293
Address
880, Kitakobayashi, Mibu, Tochigi
TEL
0282861111
kamasako@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | Tomohiko |
| Middle name | |
| Last name | Kamasako |
Organization
Dokkyo Medical University Hospital
Division name
Department of Urology, Continence Center
Zip code
321-0293
Address
880, Kitakobayashi, Mibu, Tochigi
TEL
0282861111
Homepage URL
kamasako@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University
Institute
Department
Personal name
Funding Source
Organization
Dokkyo Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Dokkyo Medical University Hospital
Address
880, Kitakobayashi, Mibu, Tochigi
Tel
0282861111
kamasako@dokkyomed.ac.jp
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
| 2020 | Year | 03 | 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
| 2020 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 10 | Month | 03 | Day |
Last modified on
| 2019 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043536
