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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004918
Receipt No. 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

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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
Email 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
Email srch.uro@mopera.ne.jp

Sponsor
Institute Saitama Red Cross Hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005812

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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