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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004354
Receipt No. 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

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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
Email

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
Email masayoshi-zaitu@kantoh.rofuku.go.jp

Sponsor
Institute Department of Urology, Kanto Rosai Hospital
Institute
Department

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
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 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
URL(English) https://upload.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


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