UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009102
Receipt number 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 09:42:38

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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 or person

Institute

Kinki University Faculty of Medicine

Institute

Department

Personal name



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

Value
https://center6.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