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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008483
Receipt No. R000009973
Scientific Title Comparative study of safety and efficacy due to the dose change from 4 mg to 8 mg silodosin for benign prostatic hyperplasia with lower urinary tract symptoms
Date of disclosure of the study information 2012/09/01
Last modified on 2018/07/25

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Basic information
Public title Comparative study of safety and efficacy due to the dose change from 4 mg to 8 mg silodosin for benign prostatic hyperplasia with lower urinary tract symptoms
Acronym Comparative study of safety and efficacy due to the dose change from 4 mg to 8 mg silodosin for benign prostatic hyperplasia with lower urinary tract symptoms
Scientific Title Comparative study of safety and efficacy due to the dose change from 4 mg to 8 mg silodosin for benign prostatic hyperplasia with lower urinary tract symptoms
Scientific Title:Acronym Comparative study of safety and efficacy due to the dose change from 4 mg to 8 mg silodosin for benign prostatic hyperplasia with lower urinary tract symptoms
Region
Japan

Condition
Condition Benign Prostatic Hyperplasia
Classification by specialty
Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Comparative study of safety and efficacy due to the dose change from 4 mg to 8 mg silodosin for benign prostatic hyperplasia with lower urinary tract symptoms
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes IPSS Score, QOL Score, Blood pressure
Key secondary outcomes maximum urinary flow rate (Qmax), residual urine volume

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 Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Given the 4 mg once daily silodosin for 12 weeks in patients newly diagnosed with benign prostatic hyperplasia and, since then the 4 mg silodosin twice daily for 12 weeks
Interventions/Control_2 Given the 4 mg once daily silodosin for 12 weeks in patients taking another alpha-blocker with benign prostatic hyperplasia, since then the 4 mg silodosin twice daily for 12 weeks
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
80 years-old >
Gender Male
Key inclusion criteria 1) Men aged over 50 and under 80 years old
2) International Prostate Symptom Score (IPSS) of>7
3) a prostate volume of >20ml
4) a maximum urinary flow rate (Qmax) of <15ml/s
5) The patients are obtained the informed consent
6) The patients undergone Wash out period 4 weeks or more (switching patients from another alpha-1 blocker)
Key exclusion criteria 1) patients are having the disease other than a benign prostatic hyperplasia (prostate cancer, bladder tumors, bladder stones, prostatitis, bladder neck sclerosis, patients, etc.)
2) Patients have received TUR-P, balloon dilation, urethral stent, hyperthermia, or radiation therapy to the pelvis, within 6 months of the start of the study
3) Self-catheterization
4) Patients with urinary tract infection
5) Patients with concomitant disease and other nervous system diseases, and it suspected to be neurogenic bladder
6) Patients with concomitant severe ischemic heart disease, cerebrovascular disease, liver dysfunction, renal dysfunction.
7) Patients with hypotension
8) Patients are having hypersensitivity to silodosin, naftopidil or taking vardenafil hydrochloride
9) Patients have treated with hormonal drug within 6 months
10) Patients treated with drugs other than tamsulosin is considered effective on urinary symptoms within a week
11) Patients was deemed by the physician as inappropriate to attend
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masato Fujisawa
Organization Kobe University Graduate School of Medicine
Division name Division of Urology
Zip code
Address 7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL 078-382-6155
Email toshiro@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshiro Shirakawa
Organization Kobe University Graduate School of Medicine
Division name Division of Urology
Zip code
Address 7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL 078-382-6155
Homepage URL
Email toshiro@med.kobe-u.ac.jp

Sponsor
Institute Division of Urology, Kobe University Graduate School of Medicine
Institute
Department

Funding Source
Organization Department of Urology, Kobe University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Hyogo PrefeCtural Awaji Hospital
Miki City Hospital
Kobe Ekisaikai Hospital,
Shakaihoken Kobe Central Hospital
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
2012 Year 09 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 Completed
Date of protocol fixation
2012 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 09 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
2012 Year 07 Month 20 Day
Last modified on
2018 Year 07 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009973

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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