UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010198 |
|---|---|
| Receipt number | 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 10:10:45 |
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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
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
kzkk77731@leto.eonet.ne.jp
Sponsor or person
Institute
Matsushita Urologocal Clinic
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011945
