Unique ID issued by UMIN | UMIN000005151 |
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Receipt number | R000006020 |
Scientific Title | The clinical study for evaluating the early efficacy and safty of alpha-1-adrenoreceptor antagonists in patient with benign prostatic hyperplasia. |
Date of disclosure of the study information | 2011/03/01 |
Last modified on | 2016/02/24 14:32:16 |
The clinical study for evaluating the early efficacy and safty of alpha-1-adrenoreceptor antagonists in patient with benign prostatic hyperplasia.
The clinical study for evaluating the early efficacy and safty of alpha-1-adrenoreceptor antagonists in patient with benign prostatic hyperplasia.
The clinical study for evaluating the early efficacy and safty of alpha-1-adrenoreceptor antagonists in patient with benign prostatic hyperplasia.
The clinical study for evaluating the early efficacy and safty of alpha-1-adrenoreceptor antagonists in patient with benign prostatic hyperplasia.
Japan |
Benign prostatic hyperplasia (BPH)
Urology |
Others
NO
To evaluate the early efficacy and safety of 4mg of silodosin twice daily or 0.2mg of tamsulosin hydrochloride once daily in untreated patient with Benign prostatic hyperplasia.
Safety,Efficacy
Exploratory
Not applicable
International Prostatic Symptom Score (I-PSS) and QOL-Score
Uroflowmetry, Residual urine volume, Prostate volume ,Japanese-Gastrointestinal symptom Rating Scale,The Bristol Stool Form,Safety (adverse events),The rate of discontinuation
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
NO
NO
Institution is not considered as adjustment factor.
NO
Numbered container method
2
Treatment
Medicine |
Silodosin 4mg twice daily
Tamsulosin hydrochloride 0.2mg daily
50 | years-old | <= |
Not applicable |
Male
previously-untreated patients with BPH
Total IPSS score>=8 and QOL score>=2
1. residual volume>=50ml
2. cases with prostate cancer, bladder cancer or interstitial cystitis
3. cases with urethral stricture
4. cases with complications which may affect the lower urinary tract symptoms such as diabetes mellitus, cerebrovascular disease and spinal cord injury
100
1st name | |
Middle name | |
Last name | Hidehiro Kakizaki |
Asahikawa Medical University Hospital
Department of Renal and Urologic Surgery
2-1-1-1 Midorigaoka-Higashi, Asahikawa, Hokkaido 078-8510, Japan
0166-68-2533
1st name | |
Middle name | |
Last name | Seiji Matsumoto |
Asahikawa Medical University Hospital
Department of Renal and Urologic Surgery
2-1-1-1 Midorigaoka-Higashi, Asahikawa, Hokkaido 078-8510, Japan
0166-68-2533
Department of Renal and Urologic Surgery, Asahikawa Medical University
none
Self funding
NO
2011 | Year | 03 | Month | 01 | Day |
Unpublished
Completed
2011 | Year | 01 | Month | 17 | Day |
2011 | Year | 03 | Month | 01 | Day |
2016 | Year | 12 | Month | 31 | Day |
2016 | Year | 12 | Month | 31 | Day |
2016 | Year | 12 | Month | 31 | Day |
2011 | Year | 02 | Month | 28 | Day |
2016 | Year | 02 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006020
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