Unique ID issued by UMIN | UMIN000009102 |
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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 |
A study of the safety of alpha1-blocker silodosin in adult women
Safety of alpha1-blocker silodosin in adult women
A study of the safety of alpha1-blocker silodosin in adult women
Safety of alpha1-blocker silodosin in adult women
Japan |
Urination impaired
Urology |
Others
NO
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.
Safety
Confirmatory
Explanatory
Phase I
Changes in blood pressure, pulse rate, and electrocardiogram waveform
I-PSS, OABSS, Uroflowmetry, PVR
Interventional
expanded access
Non-randomized
Open -no one is blinded
Uncontrolled
3
Treatment
Medicine |
2 mg silodosin daily
4 mg silodosin daily
8 mg silodosin daily
Not applicable |
Not applicable |
Female
No abnormalities found in health checkup.
Must be capable of making outpatient hospital visits.
Written informed consent can be obtained.
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.
9
1st name | |
Middle name | |
Last name | Hirotsugu UEMURA |
Kinki University Faculty of Medicine
Department of Urology
377-2, Ohno-Higashi, Osaka-Sayama Osaka 589-8511, JAPAN
1st name | |
Middle name | |
Last name | Nobutaka SHIMIZU |
Kinki University Faculty of Medicine
Department of Urology
Kinki University Faculty of Medicine
Kinki University Faculty of Medicine
Self funding
NO
2012 | Year | 10 | Month | 12 | Day |
Published
Completed
2012 | Year | 08 | Month | 16 | Day |
2012 | Year | 09 | Month | 19 | Day |
2013 | Year | 06 | Month | 19 | Day |
2013 | Year | 06 | Month | 24 | Day |
2013 | Year | 06 | Month | 24 | Day |
2013 | Year | 06 | Month | 24 | Day |
2012 | Year | 10 | Month | 12 | Day |
2014 | Year | 01 | Month | 20 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010674
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