Unique ID issued by UMIN | UMIN000003907 |
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Receipt number | R000004696 |
Scientific Title | A pilot study of the generic drug of Tamsulosin Hydrochloride to evaluate the efficacy for benign prostatic hyperplasia patients with dysuria. |
Date of disclosure of the study information | 2010/10/01 |
Last modified on | 2010/11/08 20:27:06 |
A pilot study of the generic drug of Tamsulosin Hydrochloride to evaluate the efficacy for benign prostatic hyperplasia patients with dysuria.
A pilot study of generic Tamsulosin for benign prostatic hyperplasia patients with dysuria.
A pilot study of the generic drug of Tamsulosin Hydrochloride to evaluate the efficacy for benign prostatic hyperplasia patients with dysuria.
A pilot study of generic Tamsulosin for benign prostatic hyperplasia patients with dysuria.
Japan |
benign prostatic hyperplasia
Urology |
Others
NO
To comfirm the efficacy of 4-week treatment by the generic Tamsulosin Hydrochloride for moderate benign prostatic hyperplasia patients with dysuria evaluated by international prostate symptom score (I-PSS) and QOL score.
Safety,Efficacy
Exploratory
Not applicable
international prostate symptom score : I-PSS
QOL score
Uroflowmetry (if available at the study site)
Safety(vital, labo test, AEs)
Drug compliance
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Generic Tamsulosin Hydrochloride
50 | years-old | <= |
90 | years-old | >= |
Male
1)age >= 50 at IC
2)regularly visit will be possible during study period
3)I-PSS is from 8 to 19
4)prostate volume of >= 20mL
5)residual volume <= 150ml
6)written IC
1) Patients who treated by medicine that has androgenic hormone within 4 weeks before IC.
2) Patients with cases or suspicion of prostatic cancer
3) Patients with suspicion of neurogenic bladder
4) Patients with urethral stricture
5) Patients with chronic bacterial prostatitis or active urinary tract infection
6) Past history of surgery or invasive therapy for BPH.
7) Irradiation for pelvic area within 1 year prior to IC.
8) Patients with any disease that induce dysuria (such as bladder neck contracture or urolithiasis)
9) Patients with cardiovascular disease.
10) Patients with serious disease or impairment of liver, kidney and blood
11) patients who are participated in any clinical studies within 3 months prior to the study
12) Patients who are judged inappropriate for the clinical trial by the investigator
20
1st name | |
Middle name | |
Last name | Yasunori Ishii |
Ishii Clinic
Urology
Kitaurawa 4-3-8 Urawa-ku Saitama-shi, 330-0074 Saitama JAPAN
048-833-0010
1st name | |
Middle name | |
Last name | Shinji Tsukada |
NPO MINS
Clinical trial supporting center
Shin Taiso Maruyama Building 2F 20-1 Maruyama-cho Shibuya-ku Tokyo,150-0044 JAPAN
03-6416-1868
support@clinic-irb.com
NPO MINS
ASKA Pharmaceutical
Profit organization
JAPAN
None
None
NO
石井クリニック(埼玉県)、くろおかクリニック(東京)、みずおクリニック(神奈川)、篠原Kクリニック(神奈川)
2010 | Year | 10 | Month | 01 | Day |
Unpublished
The I-PSS and the QOL score were significantly decreased after 4 weeks dosing of Restream®. And the safety profile was similar to that of the original drug. These results confirmed that 4 weeks treatment by the generic drug of Tamsulosin Hydrochloride, Restream®OD tablet, would be effective and be safety for BPH with moderate to severe dysuria.
Completed
2010 | Year | 07 | Month | 02 | Day |
2010 | Year | 09 | Month | 01 | Day |
2010 | Year | 10 | Month | 01 | Day |
2010 | Year | 10 | Month | 01 | Day |
2010 | Year | 11 | Month | 01 | Day |
2010 | Year | 11 | Month | 01 | Day |
2010 | Year | 07 | Month | 13 | Day |
2010 | Year | 11 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004696
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