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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026910
Receipt No. R000030871
Scientific Title The persistence of silodosin monotherapy and the reasons for withdrawal from treatment of previously untreated Japanese patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia
Date of disclosure of the study information 2017/04/10
Last modified on 2019/10/19

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Basic information
Public title The persistence of silodosin monotherapy and the reasons for withdrawal from treatment of previously untreated Japanese patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia
Acronym Persistence and withdrawal of silodosinn
Scientific Title The persistence of silodosin monotherapy and the reasons for withdrawal from treatment of previously untreated Japanese patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia
Scientific Title:Acronym Persistence and withdrawal of silodosinn
Region
Japan

Condition
Condition Benign prostatic hyperplasia
Classification by specialty
Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The persistence of silodosin use and the reasons for withdrawal from treatment of previously untreated Japanese patients with benign prostatic hyperplasia were evaluated.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The persistence of silodosin use and the reasons for withdrawal from treatment of previously untreated Japanese patients with benign prostatic hyperplasia
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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 Previously untreated Japanese patients aged 50 years or older who visited the hospital for lower urinary tract symptoms and were clinically diagnosed with benign prostatic hyperplasia
Key exclusion criteria Patients with a urinary tract infection, acute urinary retention, prostate cancer or neurogenic bladder, the use of an alpha-1 adrenoceptor antagonist or anti-androgen, and a history of prostatic surgery were excluded from this study.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Yoshinori
Middle name
Last name Tanaka
Organization Hokkaido Prefectural Esashi Hospital
Division name Division of Urology
Zip code 043-0022
Address Fushikidochou 484, Esashi, Hokkaido, Japan
TEL 0139-52-0036
Email rinoshiyokanata@me.com

Public contact
Name of contact person
1st name Yoshinori
Middle name
Last name Tanaka
Organization Hokkaido Prefectural Esashi Hospital
Division name Division of Urology
Zip code 043-0022
Address Fushikidochou 484, Esashi, Hokkaido, Japan
TEL 0139-52-0036
Homepage URL
Email rinoshiyokanata@me.com

Sponsor
Institute Hokkaido Prefectural Esashi Hospital
Institute
Department

Funding Source
Organization None
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 Ethics Committee of Hokkaido Prefectural Esashi Hospital
Address Fushikidochou 484, Esashi, Hokkaido, Japan
Tel 0139-52-0036
Email hofuku.esabyo2@pref.hokkaido.lg.jp

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
2017 Year 04 Month 10 Day

Related information
URL releasing protocol
Publication of results Published

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
2007 Year 03 Month 26 Day
Date of IRB
2007 Year 03 Month 26 Day
Anticipated trial start date
2007 Year 05 Month 08 Day
Last follow-up date
2013 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Patients visited the hospital between May 2007 and June 2009

Management information
Registered date
2017 Year 04 Month 08 Day
Last modified on
2019 Year 10 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030871

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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