UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of the combination effects of silodosin and dutasteride in patients with urination disorders associated with benign prostatic hyperplasia
Title of the study (Brief title)	Evaluation of the combination effects of silodosin and dutasteride in patients with urination disorders associated with benign prostatic hyperplasia
Region	Japan

Condition
Condition	Benign Prostatic Hyperplasia
Classification by specialty	Urology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	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.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change in total IPSS score before and after treatment
Key secondary outcomes	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

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Silodosin 4 mg will be orally administered twice daily after breakfast and dinner for 12 weeks.
Interventions/Control_2	Tamsulosin hydrochloride 0.2 mg will be orally administered once daily after a meal for 12 weeks.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	50 years-old <=
Age-upper limit	Not applicable
Gender	Male
Key inclusion criteria	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).
Key exclusion criteria	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.
Target sample size	60

Research contact person
Name of lead principal investigator	Hiroyoshi Suzuki
Organization	Toho University Sakura Medical Center
Division name	Department of Urology
Address	564-1 Shimoshizu, Sakura, Chiba, Japan
TEL	043-462-8811
Email	hiroyoshi.suzuki@med.toho-u.ac.jp

Public contact
Name of contact person	Katsumi Watanabe
Organization	Mebix, Inc.
Division name	Research Promotion Division
Address	Akasaka Intercity, 1-11-44, Akasaka Minato-ku, Tokyo, Japan
TEL	03-4362-4504
Homepage URL
Email	silodosin@mebix.co.jp

Sponsor
Institute	Kissei Pharmaceutical Co.,Ltd.
Institute
Department

Funding Source
Organization	Kissei Pharmaceutical Co.,Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2015 Year 06 Month 22 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 04 Month 03 Day
Anticipated trial start date	2015 Year 06 Month 22 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	This study was terminated because of temporary shipping adjustment of dutasteride.
Other related information

Management information
Registered date	2015 Year 06 Month 21 Day
Last modified on	2017 Year 03 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020781