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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000020362
Receipt No. R000023419
Scientific Title Open, parallel, prospective, randomized study between tamsulosin and tadalafil for male LUTS patients.
Date of disclosure of the study information 2016/01/01
Last modified on 2019/01/06

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Basic information
Public title Open, parallel, prospective, randomized study between tamsulosin and tadalafil for male LUTS patients.
Acronym Kawasaki Study: Open, parallel, prospective, randomized study between tamsulosin and tadalafil for male LUTS patients.
Scientific Title Open, parallel, prospective, randomized study between tamsulosin and tadalafil for male LUTS patients.
Scientific Title:Acronym 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
1st name
Middle name
Last name Takumi Takeuchi
Organization Japan Labour Health and Welfare Organization, Kanto Rosai Hospital
Division name Department of Urology
Zip code
Address 1-1 Kizukisumiyoshi-cho, Nakahara-ku, Kawasaki
TEL 044-411-3131
Email takeuchit@kantoh.rofuku.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takumi Takeuchi
Organization Japan Labour Health and Welfare Organization, Kanto Rosai Hospital
Division name Department of Urology
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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

Result
URL related to results and publications https://www.biorxiv.org/content/early/2018/12/02/404566
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2015 Year 12 Month 31 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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