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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004894
Receipt No. R000005684
Scientific Title Effect and Safety of dose-escalating treatment of Imidafenacin for Overactive Bladder : CLSS-modified-Self-Assessment Goal Achievement questionnaire
Date of disclosure of the study information 2011/01/18
Last modified on 2014/01/27

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Basic information
Public title Effect and Safety of dose-escalating treatment of Imidafenacin for Overactive Bladder : CLSS-modified-Self-Assessment Goal Achievement questionnaire
Acronym CLSS-modified-SAGE study
Scientific Title Effect and Safety of dose-escalating treatment of Imidafenacin for Overactive Bladder : CLSS-modified-Self-Assessment Goal Achievement questionnaire
Scientific Title:Acronym CLSS-modified-SAGE study
Region
Japan

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

Objectives
Narrative objectives1 To evaluate efficacy and safety of imidafenacin dose escalating treatment for patients with OAB who received treatment with imidafenacin 0.1 mg twice daily and did not have problematic side-effects and not satisfied with treatment. We also survey realistic treatment expectations of outcomes, in terms of addressing individualized treatment
Goals.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1)CLSS-modified-Self-Assessment Goal Achievement questionnaire : CLSS-modified-SAGA
2)Overactive Bladder Symptom Score : OABSS
Key secondary outcomes 1) IPSS-QOL
2) residual urine volume
3) adverse events and side-effects

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 imidafenacin 0.2mg/day-0.4mg/day bid.
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

Not applicable
Gender Male and Female
Key inclusion criteria Man and Woman over 20years who had OAB symptom, >=8voids/day, urgency and would like to have a treatment for OAB symptom.
Key exclusion criteria 1)Polyuria (daily urine volume >=3000mL)
2)Residual urine >=100mL
3)Suspect of prostate cancer
4)Indwelling catheter or self intermittent urinary catherization
5)The shift work and patients with irregular lifestyle
6)Bladder training conducted over the past 10 days
7)Active urinary tract infection
8)Having been given hormones or 5 alpha-reductase inhibitor within the past six months
9)Contraindication to imidafenacin (Primary angle-closure glaucoma , urinary retention , Obstructive intestinal disease, paralytic ileus, gastrointerstinal atony , myastania gravis )
10)Judged as being unsuitable for the trial by the researcher.
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masato Fujisawa
Organization Kobe University Graduate School of Medicine
Division name Urology
Zip code
Address 7-5-1 Kusunoki-Cho, Chuo-Ku, Kobe, 650-0017 Japan.
TEL 078-382-6155
Email urokobe@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akihiro Yanagiuchi
Organization Kobe University Graduate School of Medicine
Division name urology
Zip code
Address 7-5-1 Kusunoki-Cho, Chuo-Ku, Kobe, 650-0017 Japan.
TEL 078-382-6155
Homepage URL
Email urokobe@med.kobe-u.ac.jp

Sponsor
Institute Department of Urology, Kobe University Graduate School of Medicine, Kobe, Japan
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
2011 Year 01 Month 18 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 Completed
Date of protocol fixation
2011 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 04 Month 01 Day
Last follow-up date
2013 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 01 Month 18 Day
Last modified on
2014 Year 01 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005684

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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