UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Open, parallel, prospective, randomized study between tamsulosin and tadalafil for male LUTS patients.
Title of the study (Brief title)	Kawasaki Study: Open, parallel, prospective, randomized study between tamsulosin and tadalafil for male LUTS patients.
Region	Japan

Condition
Condition	Benign prostatic hyperplasia
Classification by specialty	Urology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Comparison of effectiveness and safety between tamsulosin and tadalafil for male patients with lower urinary tract symptoms.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	International Prostate Symptom Score after 12 weeks of drug administration
Key secondary outcomes	Overactive Bladder Symptom Score (OABSS) IIEF5 Uroflowmetry, Residual urine volume

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration	Institution is not considered as adjustment factor.
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Tadalafil (5mg) for 12 weeks
Interventions/Control_2	Tamsulosin (0.2mg) 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	Not applicable
Age-upper limit	Not applicable
Gender	Male
Key inclusion criteria	male LUTS patients with BPH
Key exclusion criteria	Patients with ongoing administration of anti-cholinergic drugs, beta-3 receptor stimulants, anti-depressants, anxiolytic, and flavoxate hydrochloride. Patients ever administered with 5 alfa-reductase inhibitors and chlormadinone acetate.
Target sample size	400

Research contact person
Name of lead principal investigator	Takumi Takeuchi
Organization	Japan Labour Health and Welfare Organization, Kanto Rosai Hospital
Division name	Department of Urology
Address	1-1 Kizukisumiyoshi-cho, Nakahara-ku, Kawasaki
TEL	044-411-3131
Email	takeuchit@kantoh.rofuku.go.jp

Public contact
Name of contact person	Takumi Takeuchi
Organization	Japan Labour Health and Welfare Organization, Kanto Rosai Hospital
Division name	Department of Urology
Address	1-1 Kizukisumiyoshi-cho, Nakahara-ku, Kawasaki
TEL	044-411-3131
Homepage URL
Email	takeuchit@kantoh.rofuku.go.jp

Sponsor
Institute	Japan Labour Health and Welfare Organization, Kanto Rosai Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
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	2016 Year 01 Month 01 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2015 Year 12 Month 31 Day
Anticipated trial start date	2016 Year 01 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol	http://www.kantoh.johas.go.jp/Portals/0/resource/shinryoka/doc/hinyoukika/KAWASAKI_StudyVer1.0.pdf
Publication of results	Partially published
URL releasing results	https://www.biorxiv.org/content/early/2018/12/02/404566
Results
Other related information

Management information
Registered date	2015 Year 12 Month 27 Day
Last modified on	2019 Year 01 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023419