UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004894 |
|---|---|
| Receipt number | 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 19:56:11 |
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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
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
urokobe@med.kobe-u.ac.jp
Sponsor or person
Institute
Department of Urology, Kobe University Graduate School of Medicine, Kobe, Japan
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005684
