UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004918 |
|---|---|
| Receipt number | R000005812 |
| Scientific Title | Silodosin 4mg versus tamsulosin 0.2mg once daily; randomized crossover study |
| Date of disclosure of the study information | 2011/01/21 |
| Last modified on | 2015/07/20 09:36:26 |
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Basic information
Public title
Silodosin 4mg versus tamsulosin 0.2mg once daily; randomized crossover study
Acronym
Silodosin 4mg versus tamsulosin 0.2mg once daily; randomized crossover study
Scientific Title
Silodosin 4mg versus tamsulosin 0.2mg once daily; randomized crossover study
Scientific Title:Acronym
Silodosin 4mg versus tamsulosin 0.2mg once daily; randomized crossover study
Region
| Japan |
Condition
Condition
Benign prostate hyperplasia
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the efficacy and safety of silodosin 4mg and tamslosin 0.2mg once daily by randomised crossover method.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
International prostate symptom score (IPSS), overactive bladder symptom score, quality of life (QOL) score
Key secondary outcomes
Uroflowmetry, blood pressure, male sexual function
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
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 preceding group (30 cases): 4 weeks of once a day administration of silodosin at 4 mg, followed by 4 weeks of once a day administration of tamsulosin at 0.2 mg.
Interventions/Control_2
Tamsulosin preceding group (30 cases): 4 weeks of once a day administration of tamsulosin at 0.2 mg, followed by 4 weeks of once a day administration of silodosin at 0.2 mg.
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
| Not applicable |
Gender
Male
Key inclusion criteria
IPSS>=8, QOL score>=3, Prostate volume (by transabdominal or transrectal ultrasound) >=20ml
Key exclusion criteria
Patients who took alfa 1 blocker within 28 days; patients who were taking phosphodiesterase 5 inhibitor, 5 alfa reductase inhibitor and antiandrogen; patients with severe renal disfunction (eGFR<30ml/min/1.73m2); or patients who were judged to be inappropirate by physicians.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira NORO |
Organization
Saitama Red Cross Hospital
Division name
Department of Urology
Zip code
Address
8-3-33 Kamiochiai, Chuo Ward, Saitama City, Saitama
TEL
+81-48-852-1111
srch.uro@mopera.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira NORO |
Organization
Saitama Red Cross Hospital
Division name
Department of Urology
Zip code
Address
8-3-33 Kamiochiai, Chuo Ward, Saitama City, Saitama
TEL
+81-48-852-1111
Homepage URL
srch.uro@mopera.ne.jp
Sponsor or person
Institute
Saitama Red Cross Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Urology, Saitama Red Cross Hospital
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
西大宮病院(埼玉県)、大宮双愛病院（埼玉県）、秀和総合病院（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 01 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://onlinelibrary.wiley.com/doi/10.1111/luts.12106/abstract
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
| 2011 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 01 | Month | 20 | Day |
Last modified on
| 2015 | Year | 07 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005812
