UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007763 |
|---|---|
| Receipt number | R000009146 |
| Scientific Title | The comparison of the curative effect on benign prostatic hyperplasia between tamsulosin and naftopidil |
| Date of disclosure of the study information | 2012/04/16 |
| Last modified on | 2012/04/16 01:28:13 |
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Basic information
Public title
The comparison of the curative effect on benign prostatic hyperplasia between tamsulosin and naftopidil
Acronym
The comparison between tamsulosin and naftopidil
Scientific Title
The comparison of the curative effect on benign prostatic hyperplasia between tamsulosin and naftopidil
Scientific Title:Acronym
The comparison between tamsulosin and naftopidil
Region
| Japan |
Condition
Condition
benign prostatic hyperplasia
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the curative effect on benign prostatic hyperplasia between tamsulosin and naftopidil
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
International Prostate Symptom Score
Urinary flow rate
Residual urine
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
tamusulosin
12 weeks
0.2 mg
once a day
Interventions/Control_2
naftopidil
12 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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
The male patients who complain of urination disorder and suitable for alfa 1 blocker treatment
I-PSS total score higher than 8 and QOL score higher than 3
Maximum urinary flow rate lower than 10ml/s
Total prostate volume larger than 20ml
Key exclusion criteria
Active prostate cancer or history
The present illness which affect urinary condision
The history of the treatment with alfa 1 blocker and/or anticholinergic drug within 4 weeks
The history of the treatment with 5 alfa reductase inhibitor on benign prostatic hyperplasia
The history of the surgical treatment which affect urinary condition
The contraindication of alfa 1 blocker
The case which the chief urologist desides not adequate for the examination
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Noboru Sakamoto |
Organization
Ibaraki Medical Center, Tokyo Medical University
Division name
Department of Urology
Zip code
Address
3-20-1 Chuo Amimachi Inasikigun, Ibaraki, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Noboru Sakamoto |
Organization
Ibaraki Medical Center, Tokyo Medical University
Division name
Department of Urology
Zip code
Address
TEL
029-887-1161
Homepage URL
uf.n.sakamoto@hotmail.com
Sponsor or person
Institute
Tokyo Medical University
Institute
Department
Personal name
Funding Source
Organization
nothing
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
東京医科大学茨城医療センター
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 04 | Month | 16 | 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 04 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 04 | 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
| 2012 | Year | 04 | Month | 16 | Day |
Last modified on
| 2012 | Year | 04 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009146
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
