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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000010321
Receipt No. R000012083
Scientific Title Comparison of Mirabegron and Imidafenacin for efficacy and safety in Japanese female patients with overactive bladder: A randomized controlled trial (COMFORT Study).
Date of disclosure of the study information 2013/03/26
Last modified on 2016/09/26

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Basic information
Public title Comparison of Mirabegron and Imidafenacin for efficacy and safety in Japanese female patients with overactive bladder: A randomized controlled trial (COMFORT Study).
Acronym Comparison of Mirabegron and Imidafenacin for efficacy and safety in Japanese female patients with overactive bladder: A randomized controlled trial (COMFORT Study).
Scientific Title Comparison of Mirabegron and Imidafenacin for efficacy and safety in Japanese female patients with overactive bladder: A randomized controlled trial (COMFORT Study).
Scientific Title:Acronym Comparison of Mirabegron and Imidafenacin for efficacy and safety in Japanese female patients with overactive bladder: A randomized controlled trial (COMFORT Study).
Region
Japan

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

Objectives
Narrative objectives1 We assess the efficacy and tolerability after 12 weeks treatment with mirabegron or imidafenacin in postmenopausal female patients with OAB.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change of total overactive bladder symptom score (OABSS)
Key secondary outcomes

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 Mirabegron 50 mg is orally administered once daily for 12 weeks.
Interventions/Control_2 Imidafenacin 0.1 mg is orally administered twice daily for 12 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 Female
Key inclusion criteria 1)OAB patients (urgency score >= 2 and total score >= 3 in overactive bladder symptom score [OABSS]).
2)Twenty year-old or more patients
3)Postmenopausal women
4)Patients from whom we received written informed consent
Key exclusion criteria 1)Premenopausal women
2)Demonstrable stress urinary incontinence
3)Post-void residual urine volume is more than 100mL, or presence of previous bladder outlet obstruction (BOO)
4)Patients with obvious inflammation, urinary tract infection, urolithiasis or malignant disease of the pelvic organs
5)Patients who have administered prohibited substances
6)Patients with previous pelvic radiation or surgery.
7)Patients who have received prohibited therapy
8)Patients who have contraindication of anticholinergic agents or Mirabegron
9)Patients with severe hepatic or renal dysfunction
10)Patients who have allergies for anticholinergic or beta-adrenergic agents
11)Patients who have received anticholinergic or beta-adrenergic agents within 12 months
12)Patients with severe cardiac dysfunction
13)Patients with arrhythmia
14)Patients with hypokalemia
15)Patients with polyuria
16)Any other patients whom the attending physician considered ineligible
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Seiichiro Ozono
Organization Hamamatsu University School of Medicine
Division name Department of Urology
Zip code
Address 1-20-1, handayama, Higashi-ku, Hamamatsu, Shizuoka, Japan
TEL 053-435-2306
Email oznsei@hama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Atsushi Otsuka
Organization Hamamatsu University School of Medicine
Division name Department of Urology
Zip code
Address 1-20-1, handayama, Higashi-ku, Hamamatsu, Shizuoka, Japan
TEL 053-435-2306
Homepage URL
Email otsuka@hama-med.ac.jp

Sponsor
Institute Department of Urology, Hamamatsu University School of Medicine
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 浜松医科大学病院(静岡県)

Other administrative information
Date of disclosure of the study information
2013 Year 03 Month 26 Day

Related information
URL releasing protocol
Publication of results 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
2013 Year 01 Month 30 Day
Date of IRB
Anticipated trial start date
2013 Year 03 Month 21 Day
Last follow-up date
2015 Year 03 Month 31 Day
Date of closure to data entry
2015 Year 05 Month 20 Day
Date trial data considered complete
2015 Year 05 Month 31 Day
Date analysis concluded
2015 Year 08 Month 31 Day

Other
Other related information

Management information
Registered date
2013 Year 03 Month 26 Day
Last modified on
2016 Year 09 Month 26 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012083

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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