UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002188 |
|---|---|
| Receipt number | R000002687 |
| Scientific Title | Comparative study of efficacy and safety of Administering 4mg once daily and 2mg twice daily of silodosin in patients with benign prostatic hyperplasia |
| Date of disclosure of the study information | 2009/08/01 |
| Last modified on | 2009/07/13 11:15:50 |
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Basic information
Public title
Comparative study of efficacy and safety of Administering 4mg once daily and 2mg twice daily of silodosin in patients with benign prostatic hyperplasia
Acronym
Comparative study of mode of administration of silodosin
Scientific Title
Comparative study of efficacy and safety of Administering 4mg once daily and 2mg twice daily of silodosin in patients with benign prostatic hyperplasia
Scientific Title:Acronym
Comparative study of mode of administration of silodosin
Region
| Japan |
Condition
Condition
benign prostatic hyperplasia
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of administered silodosin 4mg once daily
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change and change rate of I-PSS total score,subscore
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
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Silodosin 4mg once daily
Interventions/Control_2
Silodosin 2mg twice daily
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
Man with benign prostatic hyperplasia who treated by tamsulosin or naftpidil,and to fill the following items
1.I-PSS total score:over 8 points
2.QOL score:over 4 points
Key exclusion criteria
1.Men who treated by the medicin that has possibility to influence the urination function
2.prostatic cancer
3.Urinary tract infection
4.urolithiasis
5.hepatic dysfunction, renal dysfunction, cardiac disease
6.orthostatic hypotention
7.Any other clinically relevant laboratory abnormality as judged by the investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kunitaro Sanuki |
Organization
JR Tokyo General Hospital
Division name
Urology
Zip code
Address
2-1-3,Yoyogi,Shibuya-ku,Tokyo,Japan
TEL
03-3320-2200
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kunitaro Sanuki |
Organization
JR Tokyo General Hospital
Division name
Urology
Zip code
Address
2-1-3,Yoyogi,Shibuya-ku,Tokyo,Japan
TEL
03-3320-2200
Homepage URL
sanuki@jreast.co.jp
Sponsor or person
Institute
JR Tokyo General Hospital
Institute
Department
Personal name
Funding Source
Organization
Daiichi-Sankyo
Organization
Division
Category of Funding Organization
Other
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 | 08 | Month | 01 | 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 | 06 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 12 | 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 | 07 | Month | 13 | Day |
Last modified on
| 2009 | Year | 07 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002687
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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