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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000012712
Receipt No. 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

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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
Institute Department of Urology, Yotsuya Medical Cube
Institute
Department

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
URL(English) https://upload.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


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