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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009102
Receipt No. R000010674
Scientific Title A study of the safety of alpha1-blocker silodosin in adult women
Date of disclosure of the study information 2012/10/12
Last modified on 2014/01/20

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Basic information
Public title A study of the safety of alpha1-blocker silodosin in adult women
Acronym Safety of alpha1-blocker silodosin in adult women
Scientific Title A study of the safety of alpha1-blocker silodosin in adult women
Scientific Title:Acronym Safety of alpha1-blocker silodosin in adult women
Region
Japan

Condition
Condition Urination impaired
Classification by specialty
Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Few treatment options are currently available for lower urinary tract symptoms in women, such as voiding symptoms and postvoid symptoms. Establishing the safety of silodosin in adult women and demonstrating its efficacy against impaired urination in women would be of great clinical significance in that it would expand the range of treatment options for impaired urination in women. As the preliminary stage of investigation of silosidon's efficacy against impaired urination in women, this study aims to evaluate the safety of silodosin.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase I

Assessment
Primary outcomes Changes in blood pressure, pulse rate, and electrocardiogram waveform
Key secondary outcomes I-PSS, OABSS, Uroflowmetry, PVR

Base
Study type Interventional

Study design
Basic design expanded access
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 2 mg silodosin daily
Interventions/Control_2 4 mg silodosin daily
Interventions/Control_3 8 mg silodosin daily
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 Female
Key inclusion criteria No abnormalities found in health checkup.
Must be capable of making outpatient hospital visits.
Written informed consent can be obtained.
Key exclusion criteria Patient with serious comorbid heart disease.
Patient with serious comorbid liver disease or total bilirubin level more than 3 mg/dL or AST(GOT) or ALT(GPT) & 2.5 times the upper limit of the reference range.
Patient with serious comorbid kidney disease or serum creatinine & more than 1.5 mg/dL.
Patient with serious hypotension.
Woman who is pregnant, nursing, wishes to become pregnant during the study period, or cannot follow physician's instructions regarding contraception.
Patient who has taken another study drug or investigational drug within 1 month prior to beginning this study.
Others judged to be unsuited as subjects according to the Principal Investigator.
Target sample size 9

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hirotsugu UEMURA
Organization Kinki University Faculty of Medicine
Division name Department of Urology
Zip code
Address 377-2, Ohno-Higashi, Osaka-Sayama Osaka 589-8511, JAPAN
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Nobutaka SHIMIZU
Organization Kinki University Faculty of Medicine
Division name Department of Urology
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Kinki University Faculty of Medicine
Institute
Department

Funding Source
Organization Kinki University Faculty of Medicine
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

Other administrative information
Date of disclosure of the study information
2012 Year 10 Month 12 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
2012 Year 08 Month 16 Day
Date of IRB
Anticipated trial start date
2012 Year 09 Month 19 Day
Last follow-up date
2013 Year 06 Month 19 Day
Date of closure to data entry
2013 Year 06 Month 24 Day
Date trial data considered complete
2013 Year 06 Month 24 Day
Date analysis concluded
2013 Year 06 Month 24 Day

Other
Other related information

Management information
Registered date
2012 Year 10 Month 12 Day
Last modified on
2014 Year 01 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010674

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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