UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002782 |
|---|---|
| Receipt number | R000003383 |
| Scientific Title | A Randomized controlled study to evaluate the efficacy on male lower urinary tract symptoms with overactive bladder of alpha 1-adrenoceptor antagonist in monotherapy and combination therapy with Eviprostat |
| Date of disclosure of the study information | 2009/12/25 |
| Last modified on | 2012/11/19 13:30:12 |
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Basic information
Public title
A Randomized controlled study to evaluate the efficacy on male lower urinary tract symptoms with overactive bladder of alpha 1-adrenoceptor antagonist in monotherapy and combination therapy with Eviprostat
Acronym
A Randomized controlled study to evaluate the efficacy on male lower urinary tract symptoms with overactive bladder of alpha 1-adrenoceptor antagonist in monotherapy and combination therapy with Eviprostat
Scientific Title
A Randomized controlled study to evaluate the efficacy on male lower urinary tract symptoms with overactive bladder of alpha 1-adrenoceptor antagonist in monotherapy and combination therapy with Eviprostat
Scientific Title:Acronym
A Randomized controlled study to evaluate the efficacy on male lower urinary tract symptoms with overactive bladder of alpha 1-adrenoceptor antagonist in monotherapy and combination therapy with Eviprostat
Region
| Japan |
Condition
Condition
Male lower urinary tract symptoms with overactive bladder
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the efficacy and safety of Eviprostat and alpha 1-adrenoceptor antagonist compared with alpha 1-adrenoceptor antagonist in patients with male lower urinary tract symptoms with overactive bladder
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
To evaluate by using Questionnaires for urinary symptoms(IPSS and OABSS) at 4,8 and 12 weeks.
Key secondary outcomes
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 12weeks
Interventions/Control_2
EviprostatDB (3 tablets daily) and Harnal(0.2mg daily)for 12weeks.
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
Key inclusion criteria
1. 50 <or= age < 80
2.IPSS >or= 8, IPSS-QOL >or= 2
3. OABSS(Q3)>or= 2,OABSS(TOTAL) >or= 3
Key exclusion criteria
1. Patients taking medications considered likely to affect micturition
2. PSA>10ng/ml, Patients who suspected prostate cancer
3. Patients who suspected neurogenic bladder
4. Patients with urethral stricture
5. Patients with chronic prostatitis or active urinary tract infenction
6. Patients with previous surgery for BPH
7.Patients with previous intrapelvic radiation
8. Complications considered likely to affect micturition(bladder neck constriction,bladder calculus,urinary calculus, cerebrovascular disease etc).
9. Patients with severe hepatic disorders,severe renal dysfunction and severe cardiovascular disease
10. Patients with performing intermittent catheter insertion themselves
11. Patients with orthostatic hypotension
12.Patients taking OTC medication and dietary supplement considered likely to affect micturition
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiromitsu Mimata |
Organization
Oita University Faculty of Medicine
Division name
Department of Urology
Zip code
Address
Idaigaoka 1-1 , Hazama-cho, Yufu-City, Oita, Japan
TEL
097-549-4411
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuhiro Sumino |
Organization
Oita University Faculty of Medicine
Division name
Department of Urology
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Oita University Faculty of Medicine,Department of Urology
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
| 2009 | Year | 12 | Month | 25 | 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
| 2009 | Year | 02 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 11 | Month | 19 | Day |
Last modified on
| 2012 | Year | 11 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003383
