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

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 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


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

Value
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