UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011677 |
|---|---|
| Receipt number | R000013655 |
| Scientific Title | Comparison of efficacy and safety of the secondary treatment with increased fesoterodine and with mirabegron combination with 4mg fesoterodine for those who still have moderate or more overactive bladder symptoms after the initial treatment with 4mg fesoterodine: preliminary study |
| Date of disclosure of the study information | 2013/09/17 |
| Last modified on | 2022/09/19 08:55:55 |
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Basic information
Public title
Comparison of efficacy and safety of the secondary treatment with increased fesoterodine and with mirabegron combination with 4mg fesoterodine for those who still have moderate or more overactive bladder symptoms after the initial treatment with 4mg fesoterodine: preliminary study
Acronym
Comparison of efficacy and safety between increased fesoterodine and mirabegron combination for the overactive bladder resistant to the initial fesoterodine treatment.
Scientific Title
Comparison of efficacy and safety of the secondary treatment with increased fesoterodine and with mirabegron combination with 4mg fesoterodine for those who still have moderate or more overactive bladder symptoms after the initial treatment with 4mg fesoterodine: preliminary study
Scientific Title:Acronym
Comparison of efficacy and safety between increased fesoterodine and mirabegron combination for the overactive bladder resistant to the initial fesoterodine treatment.
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 the secondary treatment with increased fesoterodine 8mg and with 50mg mirabegron combination with 4mg fesoterodine for those who still have moderate or more overactive bladder symptoms after the initial treatment with 4mg fesoterodine.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change of total overactive bladder symptom score.
Key secondary outcomes
1) Changes of parameters of questonnairs
2) Changes of parameters of urodynamic studies
3) Safety
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
For 8 weeks 8mg fesoterodine will be orally administered once a day after breakfast to the patients who have still moderate or more overactive bladder symptoms after 4mg fesoterodine treatment for more than 4 weeks.
Interventions/Control_2
For 8 weeks 50mg mirabegron combination with 4mg fesoterodine will be orally administered once a day after breakfast to the patients who have still moderate or more overactive bladder symptoms after 4mg fesoterodine treatment for more than 4 weeks.
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
1) Obtaining of written informed consent
2) Male and female, more than 20 years old
3) After 4 week or more administration of fesoterodine 4mg, more than 6 points of total IPSS, and more than 2 points of OABSS 3rd question
4) Patients who have not seen side effects
5) In case of the male patients who are suitable for the enrollment of this study but have any of the following symptoms; more than 7 points of total IPSS, less than 15ml/s of maximum urinary flow rate, and more than 50ml of residual urine volume, they need preceding BPH treatment with alpha 1 blocker for more than 4 weeks or dutasteride for more than 24 weeks or anti-androgenic agent for more than 16 weeks.
Key exclusion criteria
1) Patients with the practice of catheterization past or present.
2) Residual urine volume is more than 100ml.
3) Patients who can`t urine voluntarily.
4) Neurogenic bladder, urethral stricture, urinary tract infection, urinary tract calculi, interstitial cystitis, chronic prostatitis, prostate cancer, bladder cancer
5) Patients who are contraindicated for fesoterodine administration.
6) Patients who are contraindicated for mirabegron administration.
7) Patients who have the history of the administration of contraindicated agents within 2 weeks.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasumasa Shichiri |
Organization
Otsu Minicipal Hospital
Division name
Urology
Zip code
Address
2-9-9, Motomiya, Otsu city, Shiga
TEL
077-522-4607
ysotsumhp@msn.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kimihiko Masui |
Organization
Otsu Minicipal Hospital
Division name
Urology
Zip code
Address
2-9-9, Motomiya, Otsu city, Shiga
TEL
077-522-4607
Homepage URL
k_m36@hotmail.com
Sponsor or person
Institute
Dept. of Urology, Otsu Minicipal 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
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 | 09 | Month | 17 | 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
| 2013 | Year | 07 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | Month | 09 | Day |
Last follow-up date
| 2022 | Year | 08 | 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
| 2013 | Year | 09 | Month | 07 | Day |
Last modified on
| 2022 | Year | 09 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013655
