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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000009962
Receipt No. R000011267
Scientific Title Investigation of the efficacy and safty of antimuscalinics and beta-stimulant in subjects with overactive bladder
Date of disclosure of the study information 2013/02/10
Last modified on 2015/08/20

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Basic information
Public title Investigation of the efficacy and safty of antimuscalinics and beta-stimulant in subjects with overactive bladder
Acronym Efficacy and safty of antimuscalinics and beta-stimulant in subjects with overactive bladder
Scientific Title Investigation of the efficacy and safty of antimuscalinics and beta-stimulant in subjects with overactive bladder
Scientific Title:Acronym Efficacy and safty of antimuscalinics and beta-stimulant in subjects with overactive bladder
Region
Japan

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

Objectives
Narrative objectives1 Comparative analysis in changes of overactive bladder symptoms by the administration of antimuscarinic agents and beta-stimulants.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Comparative analysis in changes of overactive bladder symptoms by the administration of antimuscarinic agents and beta-stimulants.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 BPH(n:50):Imidafenacin(0.2mg) Mirabegron(50mg)
Interventions/Control_2 BPH(n:50):Mirabegron(50mg) Imidafenacin(0.2mg)
Interventions/Control_3 iOAB(n:50):Solifenacin(5mg) Mirabegron(50mg)
Interventions/Control_4 iOAB(n:50):Mirabegron(50mg) Solifenacin(5mg)
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

Not applicable
Gender Male and Female
Key inclusion criteria 1. Patients diagnosed as enlargement of prostate and remain the symptoms of over active bladder after the treatment of alpha1 blocking agents.
2. Patients diagnosed as idiopathic overactive bladder.
Key exclusion criteria Patients in fertile age and patients with a serious heart trouble, severe liver function disorder, closed-angle glaucoma, pyloric part obstruction, duodenal obstruction, enterocleisis, paralytic ileus, gastric atony, intestinal atony, myasthenia gravis and patients under the flecainide acetate dosage, the propafenone hydrochloride dosage.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takumi Yamada
Organization Saitama Medical Center, Saitama Medical University
Division name Urology
Zip code
Address Kamoda 1981, Kawagoe, Saitama
TEL 0492283422
Email t_yamada@saitama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takumi Yamada
Organization Saitama Medical Center, Saitama Medical University
Division name Urology
Zip code
Address Kamoda 1981, Kawagoe, Saitama
TEL 049-228-3422
Homepage URL
Email t_yamada@saitama-med.ac.jp

Sponsor
Institute Department of Urology, Saitama Medical Center, Saitama Medical University
Institute
Department

Funding Source
Organization Department of Urology, Saitama Medical Center, Saitama Medical University
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 埼玉医科大学総合医療センター泌尿器科(埼玉県) Department of Urology, Saitama Medical Center, Saitama Medical University(Saitama)

Other administrative information
Date of disclosure of the study information
2013 Year 02 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 Enrolling by invitation
Date of protocol fixation
2012 Year 12 Month 20 Day
Date of IRB
Anticipated trial start date
2013 Year 03 Month 01 Day
Last follow-up date
2016 Year 06 Month 30 Day
Date of closure to data entry
2016 Year 09 Month 30 Day
Date trial data considered complete
2016 Year 09 Month 30 Day
Date analysis concluded
2016 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2013 Year 02 Month 05 Day
Last modified on
2015 Year 08 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011267

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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