UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009962 |
|---|---|
| Receipt number | 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 10:45:11 |
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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
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
t_yamada@saitama-med.ac.jp
Sponsor or person
Institute
Department of Urology, Saitama Medical Center, Saitama Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011267
