UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007269 |
|---|---|
| Receipt number | R000008576 |
| Scientific Title | A randomized controlled study to evaluate the efficacy of tamsulosin monotherapy and it combination with mirabegron on patients with overactive bladder induced by benign prostatic hyperplasia |
| Date of disclosure of the study information | 2012/02/12 |
| Last modified on | 2014/02/12 09:31:40 |
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Basic information
Public title
A randomized controlled study to evaluate the efficacy of tamsulosin monotherapy and it combination with mirabegron on patients with overactive bladder induced by benign prostatic hyperplasia
Acronym
A randomized controlled study to evaluate the efficacy of tamsulosin monotherapy and it combination with mirabegron on patients with overactive bladder induced by benign prostatic hyperplasia
Scientific Title
A randomized controlled study to evaluate the efficacy of tamsulosin monotherapy and it combination with mirabegron on patients with overactive bladder induced by benign prostatic hyperplasia
Scientific Title:Acronym
A randomized controlled study to evaluate the efficacy of tamsulosin monotherapy and it combination with mirabegron on patients with overactive bladder induced by benign prostatic hyperplasia
Region
| Japan |
Condition
Condition
Men with overactive bladder induced by benign prostatic hyperplasia
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of combination of tamsulosin with mirebegron and tamsulosin monotherapy on patients with overactive bladder induced by benign prostatic hyperplasia
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in total score of OABSS at 8 weeks
Key secondary outcomes
Changes in total score of IPSS, QOL index and Qmax at 8 weeks
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Harnal (0.2mg daily) for 8weeks
Interventions/Control_2
Batanis (50mg daily) and Harnal (0.2mg daily) for 8weeks.
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
| Not applicable |
Gender
Male
Key inclusion criteria
1. Age > or = 50 years-old
2. Patients with benign prostatic hyperplasiua who are treated by tamsulosin at least for 8 weeks
3. OABSS (Q3, urgency score) > or = 2, OABSS (total score) > or = 3
Key exclusion criteria
1. Patients with the real child plan
2. Patients suspected malignant disease
3. Patients with urinary retention
4. Ppatients with severe bladder diverticulum
5. Patients with urethral stricture
6. Patients with previous intrapelvic radiation
7. Patients with urinary tract infection, urinary stone, interstitial cystitis
8. Patients with performing clean intermittent catheterization
9. Patients with severe hepatic disorders, severe renal dysfunction and severe cardiovascular diseases
10.Patients who are judged as unsuitable for the trial by doctors.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoya Masumori |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Urology
Zip code
Address
S1 W16, Chuo-ku, Sapporo, 060-8543, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Urology
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Department of Urologu, Sapporo Medical University School of Medicine
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
| 2012 | Year | 02 | Month | 12 | 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
Terminated
Date of protocol fixation
| 2011 | Year | 12 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 01 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 02 | Month | 12 | Day |
Last modified on
| 2014 | Year | 02 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008576
