UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012712
Receipt number R000014851
Scientific Title Efficacy and safety study of flexible-dose fesoterodine on female overactive bladder symptoms
Date of disclosure of the study information 2014/01/06
Last modified on 2013/12/27 11:45:22

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Basic information

Public title

Efficacy and safety study of flexible-dose fesoterodine on female overactive bladder symptoms

Acronym

Efficacy and safety study of flexible-dose fesoterodine on female overactive bladder symptoms

Scientific Title

Efficacy and safety study of flexible-dose fesoterodine on female overactive bladder symptoms

Scientific Title:Acronym

Efficacy and safety study of flexible-dose fesoterodine on female overactive bladder symptoms

Region

Japan


Condition

Condition

overactive bladder (OAB)

Classification by specialty

Urology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy, the initial onset of action and patient satisfaction of flexible-dose fesoterodine on urinary urgency seen in female subjects with overactive bladder (OAB).

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Changes from baseline in mean of urgency episodes per 24 hours after 12-week fesoterodine treatment.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Subjects receive fesoterodine 4 mg once daily for 4 weeks; thereafter, daily dosage is maintained at 4 mg or increased to 8 mg based on the subject's and physician's subjective assessment of efficacy and tolerability.

Interventions/Control_2


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

80 years-old >=

Gender

Female

Key inclusion criteria

1.female adults with moderate/severe OAB(OABSS>=6)
2.Untreated OAB patients or OAB drug washout for at least 2 weeks before starting the treatment period.
3.Obtaining of written informed consent

Key exclusion criteria

1.subject with the episode of urinary retention within 12 months.
2.subjects with post void residual more than 100ml.
3.subject with urinary catheter indwelled or subject under clean intermittent catheterization (CIC)
4.Acute urinary tract infection(
more than 3 times within 1 year), history of urolithiasis and interstitial cystitis.
5.Polyuria(>=3000ml/day)
6.subjects who are contraindicated for fesoterodine administration.
7.Subject considered inappropriate for participating in the study by the physician.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yasukuni Yoshimura

Organization

Yotsuya Medical Cube

Division name

Department of Urology

Zip code


Address

7-7, Ni-bancho, Chiyoda-ku, Tokyo

TEL

03-3261-0401

Email

yoshimura@mcube.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yasukuni Yoshimura

Organization

Yotsuya Medical Cube

Division name

Department of Urology

Zip code


Address

7-7, Ni-bancho, Chiyoda-ku, Tokyo

TEL

03-3261-0401

Homepage URL


Email

yoshimura@mcube.jp


Sponsor or person

Institute

Department of Urology, Yotsuya Medical Cube

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



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

2014 Year 01 Month 06 Day


Related information

URL releasing protocol


Publication of results

Unpublished


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

Preinitiation

Date of protocol fixation

2013 Year 12 Month 05 Day

Date of IRB


Anticipated trial start date

2014 Year 03 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 12 Month 27 Day

Last modified on

2013 Year 12 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014851


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name