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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000010327
Receipt No. 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

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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
Email 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
Email miyagawa@uro.med.osaka-u.ac.jp

Sponsor
Institute Osaka-Hokuriku maleLUTS Conference
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012088

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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