UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002066 |
|---|---|
| Receipt number | 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 10:06:03 |
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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
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
Sponsor or person
Institute
Department of Urology,Kawasaki Medical School
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002479
