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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002782
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Oita University Faculty of Medicine,Department of Urology
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003383

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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