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Recruitment status Completed
Unique ID issued by UMIN UMIN000010655
Receipt No. R000012463
Scientific Title Efficacy of naftopidil for LUTS in BPH with OAB patients
Date of disclosure of the study information 2013/05/07
Last modified on 2014/12/05

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Basic information
Public title Efficacy of naftopidil for LUTS in BPH with OAB patients
Acronym Dose dependency of a1-blocker in its efficacy
Scientific Title Efficacy of naftopidil for LUTS in BPH with OAB patients
Scientific Title:Acronym Dose dependency of a1-blocker in its efficacy
Region
Japan

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

Objectives
Narrative objectives1 To investigate dose dependency of naftopidil for LUTS in BPH with OAB patients
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes IPSS
OABSS
OAB-q
Uroflowmetry
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Naftopidil
8 weeks
50 mg /day
once a day"
Interventions/Control_2 Naftopidil
8 weeks
75 mg /day
once a day"
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 1) IPSS total score &sup3;8
2) Prostate volume &sup3;20 mL
3) Maximum flow rate <15 mL/s
4) Residual urine volume <100 mL
5) OABSS total score &sup3;3 and OABSS urgency score &sup3;2"
Key exclusion criteria 1) With suspected neurogenic bladder associated with cerebral vascular disease, spinal cord injury, diabetes, etc.
2) With suspected prostate cancer
3) With urinary tract infection and urethral stricture
4) Taking radiotherapy in their pelvice
5) With serious disorder for heart, kidney, liver or blood
6) With taking a1-blocker within a last month"
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name FUJISAWA, Masato
Organization Kobe University Graduate School of Medicine
Division name Urology
Zip code
Address 7-5-1, Kusunoki-cho, Chuo-ku, Kobe
TEL 078-382-6155
Email

Public contact
Name of contact person
1st name
Middle name
Last name SHIRAKAWA, Toshiro
Organization Kobe University Graduate School of Medicine
Division name Urology
Zip code
Address 7-5-1, Kusunoki-cho, Chuo-ku, Kobe
TEL
Homepage URL
Email

Sponsor
Institute Kobe University
Institute
Department

Funding Source
Organization Kobe University
Organization
Division
Category of Funding Organization Other
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
2013 Year 05 Month 07 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
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 Completed
Date of protocol fixation
2013 Year 05 Month 07 Day
Date of IRB
Anticipated trial start date
2013 Year 07 Month 01 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
2013 Year 05 Month 07 Day
Last modified on
2014 Year 12 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012463

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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