UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of silodosin versus tadalafil in patients with urination disorders associated with benign prostatic hyperplasia
Title of the study (Brief title)	Evaluation of silodosin versus tadalafil 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	< Treatment period I > This research is intended to evaluate the efficacy and safety of oral administration of silodosin 8 mg/day or tadalafil 5 mg/day for 8 weeks in patients with urination disorders associated with benign prostatic hyperplasia using a parallel-group design. < Treatment period II > Subjects in the tadalafil group in treatment period I will be divided into 2 groups; a group switched to silodosin 8 mg/day and a group continuing tadalafil 5 mg/day to evaluate the efficacy and safety of oral administration of each drug for 8 weeks using a parallel-group design.
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 (treatment period I, Weeks 1, 2, 3, 4: treatment period II, Weeks 9, 10, 11, 12) 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) Subgroup analyses of primary/secondary endpoints by subject's baseline characteristic (age, BMI, duration of illness, OAB/ED/renal disease/hepatic disease and other complications, treatment history, prostate volume, baseline data of each endpoint at the start of treatment [Week 0]) 11) 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	3
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 8 weeks.
Interventions/Control_2	Tadalafil 5 mg will be orally administered once daily for 8 weeks. Subsequently, Tadalafil will be switched to silodosin 4 mg, which will be orally administered twice daily after breakfast and dinner for 8 weeks.
Interventions/Control_3	Tadalafil 5 mg will be orally administered once daily for 8 weeks. Subsequently, Tadalafil 5 mg will continue to be orally administered once daily for 8 weeks.
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	60 years-old <=
Age-upper limit	Not applicable
Gender	Male
Key inclusion criteria	Patients diagnosed with benign prostatic hyperplasia by digital rectal examination or ultrasonography who provide written consent to participate in the research. 1) Patients meet the following conditions as confirmed through inspection and examination at the start of treatment (Week 0): Total IPSS Score of 13 or higher QOL score of 3 or higher Prostate volume of 20 mL or higher Residual urine volume of 100 mL or less 2) Patients are 60 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 or tadalafil. 2) Patients have prostate cancer. 3) Patients have lower urinary tract symptoms possibly due to urinary tract infection or neurogenic bladder. 4) Patients have used silodosin or tadalafil within 12 weeks prior to Week 0.
Target sample size	180

Research contact person
Name of lead principal investigator	Masaki Yoshida
Organization	National Center for Geriatrics and Gerontology
Division name	Division of Urology, Department of Surgery and Intensive Care
Address	7-430 Morioka-cho, Obu, Aichi, Japan
TEL	0562-46-2311
Email	myoshida@ncgg.go.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 08 Month 21 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2015 Year 04 Month 03 Day
Anticipated trial start date	2015 Year 08 Month 21 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	Published
URL releasing results	http://onlinelibrary.wiley.com/doi/10.1111/luts.12177/epdf
Results
Other related information

Management information
Registered date	2015 Year 08 Month 20 Day
Last modified on	2017 Year 09 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021187