UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010327 |
|---|---|
| Receipt number | R000012088 |
| Scientific Title | Good combination therapy with alpha-blocker plus imidafenacin or mirabegron for nocturia in overactive bladder with benign prostatic hyperplasia; prospective randomized trial |
| Date of disclosure of the study information | 2013/03/27 |
| Last modified on | 2019/04/02 17:54:56 |
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Basic information
Public title
Good combination therapy with alpha-blocker plus imidafenacin or mirabegron for nocturia in overactive bladder with benign prostatic hyperplasia; prospective randomized trial
Acronym
Good-Night study 2
Scientific Title
Good combination therapy with alpha-blocker plus imidafenacin or mirabegron for nocturia in overactive bladder with benign prostatic hyperplasia; prospective randomized trial
Scientific Title:Acronym
Good-Night study 2
Region
| Japan |
Condition
Condition
Overactive Bladder
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety of imidafenacin or mirabegron after failed treatment by alpha1 blocker in male OAB/BPH patients with nocturia
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Mean frequency of nocturnal mictrition
Key secondary outcomes
1) N-QOL
2) OABSS
3) IPSS&QOL
4) mean night-time urine volume
5) voided volume
6) residual urine volume
7) adverse events and side-effects
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Any alpha-blocker plus imidafenacin 0.2mg/day bid.
Interventions/Control_2
Any alpha-blocker plus mirabegron 50mg/day qd after meal
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
Key inclusion criteria
Patients with
1) alpha-blocker treatment over 4 weeks
2) urinary urgency more than once a week (Question 3 of OABSS >=2)
3) nocturia more than twice a day on average in bladder diary
4) more than 20 years old
Key exclusion criteria
1) Urinary retention within a year
2) Residual urine >=50mL
3) Strong suspect of prostate cancer
4) Treatment of any anti-muscarinic agent or beta-stimulants within a month.
5) Indwelling catheter or self intermittent urinary catherization
6) Diseases that affect nocturia (sleep apnea syndrome, restless legs syndrome, insomnia etc.)
7) The shift work, circadian rhythm disorder, and irregular lifestyle
8) Bladder training conducted over the past 10 days
9) Active acute urinary tract infection
10) Hormones or 5 alpha-reductase inhibitor started to have within the past six months
11) Contraindication to imidafenacin (primary angle-closure glaucoma, urinary retention, obstructive intestinal disease, paralytic ileus, gastrointestinal atony, myastania gravis)
12) Contraindication to mirabegron (severe heart disease, severe liver dysfunction, treatment of flecainide or propaphenone)
13) Untreated severe hypertension (more than Class II in JSH 2009, SBP>=160mmHg or DBP>= 100mmHg)
14) Judged as being unsuitable for the trial by physician.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Osamu Yokoyama |
Organization
Faculty of Medical Science, University of Fukui
Division name
Urology
Zip code
Address
23-3 Matsuokashimoaizuki, Eiheiji-cho, Fukui
TEL
0776-61-8396
oyoko@u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasushi Miyagawa |
Organization
Osaka-Hokuriku male LUTS Conference Secretariat(Osaka University Hospital)
Division name
Urology
Zip code
Address
Yamadaoka 2-2, Suita, Osaka 565-0871
TEL
06-6879-3531
Homepage URL
miyagawa@uro.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka-Hokuriku maleLUTS Conference
Institute
Department
Personal name
Funding Source
Organization
The Supporting Center of the Clinical Research and Education
Organization
Division
Category of Funding Organization
Other
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
大阪医科大学附属病院（大阪府）、大阪市立大学医学部附属病院（大阪府）、大阪大学医学部附属病院（大阪府）、金沢大学附属病院（石川県）、関西医科大学附属枚方病院（大阪府）、関西医科大学附属滝井病院（大阪府）、近畿大学医学部附属病院（大阪府）、富山大学附属病院（富山県）、福井大学附属病院（福井県）以上8大学の泌尿器科およびその関連施設
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 03 | Month | 27 | 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
Enrolling by invitation
Date of protocol fixation
| 2012 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2015 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 03 | Month | 27 | Day |
Last modified on
| 2019 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012088
