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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010198
Receipt No. R000011945
Scientific Title Compare efficacy and safety of alpha1-blockers in patients with benign prostatic hyperplasia
Date of disclosure of the study information 2013/03/11
Last modified on 2015/09/09

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Basic information
Public title Compare efficacy and safety of alpha1-blockers in patients with benign prostatic hyperplasia
Acronym Compare the treatment of the alpha1-blockers
Scientific Title Compare efficacy and safety of alpha1-blockers in patients with benign prostatic hyperplasia
Scientific Title:Acronym Compare the treatment of the alpha1-blockers
Region
Japan

Condition
Condition Benign Prostatic Hyperplasia
Classification by specialty
Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the treatment of Tamsulosin and Naftopidil in patients with benign prostatic hyperplasia
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes International Prostate Symptom Score
BPH Impact Index
Key secondary outcomes Blood Pressure

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 Tamusulosin
8 weeks
0.2 mg
once a day
Interventions/Control_2 Naftopidil
8 weeks
75 mg
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)The patients aged more than 50 years who written informed consent was obtained .
2)The patients who had a diagnosis of bengin prostatic hyperplasia with non-treatment.
3)I-PSS total score higher than 8 and QOL score higher than 2
Key exclusion criteria 1)Patients who have taken a medicine that influence on the urination function.
2)Patients with suspected prostate cancer.
3)Patients with suspected Neurogenic Bladder.
4)Patients with urethral stricture.
5)Patients who gave radiotherapy in the pelvis.
6)Patients with urinary tract infection, calculus urinary, cystitis interstitial.
7)Patients with serious impaired liver function, serious renal dysfunction, serious heart disorder.
8)Patients with orthostatic hypotension.
9)Patients with myasthenia gravis.
10)Maximum urinary flow rate=>15mL/s
11)The inappropriate patients who is judged by urologist.
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masami Matsushita
Organization Matsushita Urologocal Clinic
Division name Department of Urology
Zip code
Address 459 Minamitada, Kaibara-cho, Tanba-shi, Hyogo-ken, Japan
TEL 0795-73-0266
Email kzkk77731@leto.eonet.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masami Matsushita
Organization Matsushita Urologocal Clinic
Division name Department of Urology
Zip code
Address 459 Minamitada, Kaibara-cho, Tanba-shi, Hyogo-ken, Japan
TEL 0795-73-0266
Homepage URL
Email kzkk77731@leto.eonet.ne.jp

Sponsor
Institute Matsushita Urologocal Clinic
Institute
Department

Funding Source
Organization Astellas Pharma Inc
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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 松下泌尿器科医院(兵庫県)

Other administrative information
Date of disclosure of the study information
2013 Year 03 Month 11 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
2012 Year 01 Month 17 Day
Date of IRB
Anticipated trial start date
2012 Year 02 Month 12 Day
Last follow-up date
2014 Year 09 Month 30 Day
Date of closure to data entry
2014 Year 11 Month 25 Day
Date trial data considered complete
2014 Year 11 Month 25 Day
Date analysis concluded
2014 Year 12 Month 11 Day

Other
Other related information

Management information
Registered date
2013 Year 03 Month 09 Day
Last modified on
2015 Year 09 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011945

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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