Unique ID issued by UMIN | UMIN000017995 |
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Receipt number | R000020781 |
Scientific Title | Evaluation of the combination effects of silodosin and dutasteride in patients with urination disorders associated with benign prostatic hyperplasia |
Date of disclosure of the study information | 2015/06/22 |
Last modified on | 2017/03/29 09:58:05 |
Evaluation of the combination effects of silodosin and dutasteride in patients with urination disorders associated with benign prostatic hyperplasia
Evaluation of the combination effects of silodosin and dutasteride in patients with urination disorders associated with benign prostatic hyperplasia
Evaluation of the combination effects of silodosin and dutasteride in patients with urination disorders associated with benign prostatic hyperplasia
Evaluation of the combination effects of silodosin and dutasteride in patients with urination disorders associated with benign prostatic hyperplasia
Japan |
Benign Prostatic Hyperplasia
Urology |
Others
NO
This research is intended to evaluate the efficacy and safety of switching tamsulosin hydrochloride to silodosin in patients with benign prostatic hyperplasia receiving combination therapy with tamsulosin hydrochloride and dutasteride for 12 weeks in comparison with continued treatment with tamsulosin hydrochloride and dutasteride.
Safety,Efficacy
Change in total IPSS score before and after treatment
1) Change in IPSS subscore before and after treatment
2) Percentage of subjects with an improvement of 25% or higher for total IPSS score
3) Change in QOL score before and after treatment
4) Change in OABSS score before and after treatment
5) Change in OABSS subscore before and after treatment
6) Changes in total IPSS score, QOL score, and OABSS score before and after treatment in the early stage of treatment (Weeks 1, 2, 3, 4)
7) Change in maximum urine flow rate before and after treatment
8) Change in mean urine flow rate before and after treatment
9) Change in residual urine volume before and after treatment
10) Acute urinary retention or surgery for benign prostatic hyperplasia
11) Subgroup analyses of primary/secondary endpoints by subject's baseline characteristic (age, BMI, duration of illness, OAB/renal disease/hepatic disease and other complications, treatment history, prostate volume, baseline data of each endpoint at the start of treatment [Week 0])
12) Adverse events and adverse drug reactions
Interventional
Parallel
Randomized
Open -no one is blinded
Active
2
Treatment
Medicine |
Silodosin 4 mg will be orally administered twice daily after breakfast and dinner for 12 weeks.
Tamsulosin hydrochloride 0.2 mg will be orally administered once daily after a meal for 12 weeks.
50 | years-old | <= |
Not applicable |
Male
Patients with benign prostatic hyperplasia receiving combination therapy with tamsulosin hydrochloride and dutasteride who provide written consent to participate in the research.
1) Patients have received tamsulosin hydrochloride for at least 12 weeks prior to the start of treatment (Week 0) and dutasteride for at least 24 weeks prior to Week 0 according to fixed doses and modes of administration.
2) Patients meet the following conditions as confirmed through inspection and examination at Week 0.
Total IPSS Score of 8 or higher
QOL score of 3 or higher
Residual urine volume of 150 mL or less
3) Patients are 50 years or older (at the time of consent).
1) Patients have any of the contraindications listed in the package inserts for silodosin, tamsulosin hydrochloride, or dutasteride.
2) Patients have prostate cancer.
3) Patients have lower urinary tract symptoms possibly due to urinary tract infection or neurogenic bladder.
60
1st name | |
Middle name | |
Last name | Hiroyoshi Suzuki |
Toho University Sakura Medical Center
Department of Urology
564-1 Shimoshizu, Sakura, Chiba, Japan
043-462-8811
hiroyoshi.suzuki@med.toho-u.ac.jp
1st name | |
Middle name | |
Last name | Katsumi Watanabe |
Mebix, Inc.
Research Promotion Division
Akasaka Intercity, 1-11-44, Akasaka Minato-ku, Tokyo, Japan
03-4362-4504
silodosin@mebix.co.jp
Kissei Pharmaceutical Co.,Ltd.
Kissei Pharmaceutical Co.,Ltd.
Profit organization
NO
2015 | Year | 06 | Month | 22 | Day |
Unpublished
This study was terminated because of temporary shipping adjustment of dutasteride.
Terminated
2015 | Year | 04 | Month | 03 | Day |
2015 | Year | 06 | Month | 22 | Day |
2015 | Year | 06 | Month | 21 | Day |
2017 | Year | 03 | Month | 29 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020781
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