Unique ID issued by UMIN | UMIN000002126 |
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Receipt number | R000002595 |
Scientific Title | Clinical effect of Eviprostat in patients with high levels of PSA |
Date of disclosure of the study information | 2009/06/26 |
Last modified on | 2013/01/07 21:09:07 |
Clinical effect of Eviprostat in patients with high levels of PSA
Clinical effect of Eviprostat in patients with high levels of PSA
Clinical effect of Eviprostat in patients with high levels of PSA
Clinical effect of Eviprostat in patients with high levels of PSA
Japan |
patients with high levels of PSA
Urology |
Malignancy
NO
Changes of inflammation in prostate, serum PSA levels and lower urinary tract symptoms by intake of Eviprostat will be examined in patients with high levels of PSA without prostate cancer.
Efficacy
Exploratory
Pragmatic
Not applicable
Histological changes of prostate inflammation in prostate biopsy will be examined between before and after the intake of Eviprostat for 12 months.
Inflammation is assessed across all scores and the amount of inflammation scored as none (0), mild (1), moderate (2), or marked (3).
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
No treatment
2
Prevention
Medicine |
Three tablets of Eviprostat three times per day for 12 months
no medication
40 | years-old | <= |
Not applicable |
Male
1. age >=40
2. Written informed consent
3. serum PSA levels >=4.0
4. Patients without prostate cancer
5. Patients with lower urinary tract symptoms
1) patients with prostate cancer
2) patients with previous operation on prostate
3) Subjects taking any anti-androgen drugs
4) patients with prostatitis
5) Subjects with active urinary infection
6) Subjects with urethral catheter
7) Subjects with irritation to Eviprostat
8) Severe renal dysfunction
9) Severe liver dysfunction
10) Other ineligible subjects
200
1st name | |
Middle name | |
Last name | Hiroshi Fukuhara |
University of Tokyo Hospital
Department of Uology
7-3-1 Hongo, Bunkyo-ku Tokyo
1st name | |
Middle name | |
Last name | Hiroshi Fukuhara |
University of Tokyo Hospital
Department of Uology
Department of Urology, University of Tokyo Hospita
Department of Urology, University of Tokyo Hospital
NO
2009 | Year | 06 | Month | 26 | Day |
Unpublished
Completed
2009 | Year | 06 | Month | 10 | Day |
2009 | Year | 06 | Month | 01 | Day |
2012 | Year | 05 | Month | 01 | Day |
2009 | Year | 06 | Month | 26 | Day |
2013 | Year | 01 | Month | 07 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002595
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