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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010060
Receipt No. R000011779
Scientific Title Clinical efficacy and safety of a beta3-adrenoceptor agonist and an antimuscarinic agent in female patients with overactive overactive bladder: a randomized crossover study
Date of disclosure of the study information 2013/02/18
Last modified on 2016/01/29

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Basic information
Public title Clinical efficacy and safety of a beta3-adrenoceptor agonist and an antimuscarinic agent in female patients with overactive overactive bladder: a randomized crossover study
Acronym Clinical comparison between miragegron and imidafenacin: a randomized crossover study
Scientific Title Clinical efficacy and safety of a beta3-adrenoceptor agonist and an antimuscarinic agent in female patients with overactive overactive bladder: a randomized crossover study
Scientific Title:Acronym Clinical comparison between miragegron and imidafenacin: a randomized crossover study
Region
Japan

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

Objectives
Narrative objectives1 To compare efficacy and safety between a beta3-adrenoceptor agonist and an antimuscarinic agent
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Change of average urinary frequency for 24 hours
Key secondary outcomes Change of average urgency frequency for 24 hours, Change of average urinary incontinence frequency for 24 hours, Change of average voided volume, Change of average nocturnal frequency, Change of QOL score, Change of flow rate, Change of post-void residual urine

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation
Institution consideration
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Mirabegron (50 mg daily) for 8weeks, wash out for 2 weeks and Imidafenacin (0.2 mg daily) for 8weeks
Interventions/Control_2 Imidafenacin (0.2 mg daily) for 8weeks, wash out for 2 weeks and mirabegron (50 mg daily)
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
50 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria In overactive bladder symptom score (OABSS), Q3 (urgency) score is 2 and more, and total score is 3 and more.
Key exclusion criteria 1. Postvoid residual urine 50 mL and more, 2. Active urinary tract infection, 3. Histories of malignant tumors in the lower urinary tract, 4. Histories of surgery for the lower urinary tract in the last 3 months
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazumasa Torimoto
Organization Nara Medical University
Division name Urology
Zip code
Address 840 Shijo-cho, Kashihara, Nara
TEL 0744-22-3051
Email torimoto@naramed-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazumasa Torimoto
Organization Nara Medical University
Division name Urology
Zip code
Address 840 Shijo-cho, Kashihara, Nara
TEL 0744-22-3051
Homepage URL
Email torimoto@naramed-u.ac.jp

Sponsor
Institute Nara Medical University
Institute
Department

Funding Source
Organization Astellas Pharma Inc.
Organization
Division
Category of Funding Organization Profit organization
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

Other administrative information
Date of disclosure of the study information
2013 Year 02 Month 18 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Completed
Date of protocol fixation
2012 Year 01 Month 25 Day
Date of IRB
Anticipated trial start date
2012 Year 01 Month 27 Day
Last follow-up date
2015 Year 08 Month 31 Day
Date of closure to data entry
2015 Year 08 Month 31 Day
Date trial data considered complete
2015 Year 08 Month 31 Day
Date analysis concluded
2015 Year 09 Month 30 Day

Other
Other related information

Management information
Registered date
2013 Year 02 Month 18 Day
Last modified on
2016 Year 01 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011779

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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