UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020362 |
|---|---|
| Receipt number | 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 22:25:57 |
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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
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
takeuchit@kantoh.rofuku.go.jp
Sponsor or person
Institute
Japan Labour Health and Welfare Organization, Kanto Rosai Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023419
