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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002344
Receipt No. R000002874
Scientific Title Good combination therapy, alpha-blocker and imidafenacin, for Nocturia of Benign Prostatic Hyperplasia with OAB in Osaka-Hokuriku study group.
Date of disclosure of the study information 2009/08/17
Last modified on 2014/09/29

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Basic information
Public title Good combination therapy, alpha-blocker and imidafenacin, for Nocturia of Benign Prostatic Hyperplasia with OAB in Osaka-Hokuriku study group.
Acronym Good-Night study
Scientific Title Good combination therapy, alpha-blocker and imidafenacin, for Nocturia of Benign Prostatic Hyperplasia with OAB in Osaka-Hokuriku study group.
Scientific Title:Acronym Good-Night study
Region
Japan

Condition
Condition Overactive Bladder
Classification by specialty
Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Combination therapy with alpha-1 blocker and imidafenacin in Benign Prostatic Hyperplasia with OAB: Effects on Nocturia and nocturnal sleep and safety
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1) Mean freaquency of nocturnal mictrition,
2) N-QOL,
3) Pittsburgh Sleep Quality Index)
Key secondary outcomes 1) OABSS
2) IPSS&QOL
3) mean night-time urine
(mean nocturnal urine volume)
4) maximum voided volume
5) residual urine volume
6) 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
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 continuous oral administration of alpha-blocker (be available to any medicine)
Interventions/Control_2 Any alpha-blocker plus imidafenacin 0.2mg/day bid.
Interventions/Control_3 Any alpha-blocker plus imidafenacin 0.1mg/day administration before sleep
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

Not applicable
Age-upper limit

Not applicable
Gender Male
Key inclusion criteria Patients has urinary urgency once a week or more and also has nocturia (Question 2 of OABSS>=2 and Question 7 of IPSS>=2) after alpha-blocker treatment over the past 1 month or longer.
(be available to all ages)
Key exclusion criteria 1) Urinary retention within a year
2) Residual urine >=50mL
3) 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 and circadian rhythm disorder, patients with irregular lifestyle
8) Bladder training conducted over the past 10 days
9) Active urinary tract infection
10) Having been given hormones or 5 alpha-reductase inhibitor within the past six months
11) Contraindication to Imidafenacin (Primary angle-closure glaucoma, urinary retention, Obstructive intestinal disease, paralytic ileus, gastrointerstinal atony, myastania gravis)
12) Judged as being unsuitable for the trial by the researcher.
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 0776-61-3111
Email oyoko@u-fukui.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasushi Miyagawa
Organization Osaka-Hokuriku maleLUTS 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 Secretariat
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization None

Other related organizations
Co-sponsor Osaka Medical College
Osaka City Univ.
Osaka Univ.
Kanazawa Medical Univ.
Kanazawa Univ.
Kansai Medical Univ.
Kinki Univ.
University of Toyama
University of Fukui
and the related facilities
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

Other administrative information
Date of disclosure of the study information
2009 Year 08 Month 17 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/25224929
Number of participants that the trial has enrolled
Results
Add-on anticholinaergic therapy for residual nocturia in patients with lower urinary tract symptoms receiving alpha 1- blocker treatmen: a multi-centre, prospective, randomised study.
A short half-life anticholinergic is suggested to be safe and effective as an add-on therapy for residual nocturia in patients with male LUTS receiving alpha 1-blocker treatment. Anticholinergic admiistration nightly could reduce the nocturnal urine volume.
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
2009 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 05 Month 01 Day
Last follow-up date
2011 Year 07 Month 01 Day
Date of closure to data entry
2011 Year 11 Month 01 Day
Date trial data considered complete
2011 Year 12 Month 01 Day
Date analysis concluded
2011 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 08 Month 17 Day
Last modified on
2014 Year 09 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002874

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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