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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000002066
Receipt No. R000002479
Scientific Title Effect of alfha1-adrenoceptor antagonist in lower urinary tract symptoms after high dose brachytherapy for prostate cancer
Date of disclosure of the study information 2009/06/15
Last modified on 2009/06/08

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Basic information
Public title Effect of alfha1-adrenoceptor antagonist in lower urinary tract symptoms after high dose brachytherapy for prostate cancer
Acronym Effect of alfha1-adrenoceptor antagonist in lower urinary tract symptoms after high dose brachytherapy for prostate cancer
Scientific Title Effect of alfha1-adrenoceptor antagonist in lower urinary tract symptoms after high dose brachytherapy for prostate cancer
Scientific Title:Acronym Effect of alfha1-adrenoceptor antagonist in lower urinary tract symptoms after high dose brachytherapy for prostate cancer
Region
Japan

Condition
Condition prostate cancer
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy of silodosin in Lower urinary tract symptoms after high dose rate brachytherapy for prostate cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes IPSS total score
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 YES
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Silodosin take 4mg twice daily after breakfast and dinner immediately before the radiation therapy
Interventions/Control_2 Silodosin take 4mg twice daily after breakfast and dinner immediately after radiation therapy
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
40 years-old <=
Age-upper limit

Not applicable
Gender Male
Key inclusion criteria Over 40 years of age
Key exclusion criteria 1)Having an allergic history of silodosin
2)Having a neuropathic bladder or bladder neck sclerosis or urethral stricture or bladder stone,or sever bladder diverticulum
3)Having an Active urinary tract infection
4)Having a severe ischemic heart disease or cerebrovascular disorder or hepatic disease or renal disease
5)Judged sa being unsuitable for the trial by the doctor
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Jou Yoshimasa
Organization Kawasaki Medical School
Division name Department of Urology
Zip code
Address 577 Matsushima, Kurashiki, Okayama 701-0192
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kawasaki Medical School
Division name Department of Urology
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Department of Urology,Kawasaki Medical School
Institute
Department

Funding Source
Organization Department of Urology,Kawasaki Medical School
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 06 Month 15 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 Preinitiation
Date of protocol fixation
2009 Year 05 Month 27 Day
Date of IRB
Anticipated trial start date
2009 Year 07 Month 01 Day
Last follow-up date
2011 Year 07 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 06 Month 10 Day
Last modified on
2009 Year 06 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002479

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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