UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004354 |
|---|---|
| Receipt number | R000005207 |
| Scientific Title | Comparative evaluation of the safety and efficacy of long term use of anti-cholinergic, Imidafenacin and Solifenacin, on overactive bladder: a prospective randomized trial. |
| Date of disclosure of the study information | 2010/11/10 |
| Last modified on | 2011/04/12 10:09:29 |
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Basic information
Public title
Comparative evaluation of the safety and efficacy of long term use of anti-cholinergic, Imidafenacin and Solifenacin, on overactive bladder: a prospective randomized trial.
Acronym
LIST study
Scientific Title
Comparative evaluation of the safety and efficacy of long term use of anti-cholinergic, Imidafenacin and Solifenacin, on overactive bladder: a prospective randomized trial.
Scientific Title:Acronym
LIST study
Region
| Japan |
Condition
Condition
overactive bladder
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the safety and efficacy of long term use of anti-cholinergic, Imidafenacin and Solifenacin, for the overactive bladder patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1)OABSS
2)Side effects(dry mouth, constipation, vision blurred etc)
Key secondary outcomes
1)King's Health Questionnaire
2)QTc interval
3)Residual urine volume
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Imidafenacin 0.2mg/day bid
Interventions/Control_2
Solifenacin 5mg/day qd
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
| 50 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with previously untreated OAB, has urinary urgency once a week or more (Question 2 of OABSS>=2) and also has total OABSS>=3.
Key exclusion criteria
1)Contraindication to
anti-cholinergic agents.
(Primary angle-closure glaucoma
, urinary retention , Obstructive
intestinal disease, paralytic ileus,
gastrointestinal atony, myastania
gravis)
2)Residual urine >=100mL.
3)Suspect of prostate cancer.
4)Active urinary tract infection.
5)Judged as being unsuitable for the
trial by the researcher.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masayoshi Zaitsu |
Organization
Kanto Rosai Hospital
Division name
Urology
Zip code
Address
1-2 Kizukisumiyoshi-cho, Nakahara-ku, Kawasaki-city, Kanagawa, Japan 211-8510
TEL
044-411-3131
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masayoshi Zaitsu |
Organization
Kanto Rosai Hospital
Division name
Urology
Zip code
Address
1-2 Kizukisumiyoshi-cho, Nakahara-ku, Kawasaki-city, Kanagawa, Japan 211-8510
TEL
044-411-3131
Homepage URL
masayoshi-zaitu@kantoh.rofuku.go.jp
Sponsor or person
Institute
Department of Urology, Kanto Rosai Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
None
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
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
関東労災病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 11 | Month | 10 | 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
| 2008 | Year | 12 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 01 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 01 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 02 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 10 | Month | 07 | Day |
Last modified on
| 2011 | Year | 04 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005207
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
