UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010321 |
|---|---|
| Receipt number | 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 15:15:20 |
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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
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
otsuka@hama-med.ac.jp
Sponsor or person
Institute
Department of Urology, Hamamatsu University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012083
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