UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003609 |
|---|---|
| Receipt number | R000004331 |
| Scientific Title | The effects of selective alpha-1-adrenergic receptor antagonists in patients with lower urinary tract symptoms caused by benign prostatic hyperplasiawho failed to obtain sufficient efficacy by previous alpha-1-blockades. . A comparison of Naftopidil or Silodosin. |
| Date of disclosure of the study information | 2010/05/16 |
| Last modified on | 2010/05/12 07:32:24 |
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Basic information
Public title
The effects of selective alpha-1-adrenergic receptor antagonists in patients with lower urinary tract symptoms caused by benign prostatic hyperplasiawho failed to obtain sufficient efficacy by previous alpha-1-blockades.
. A comparison of Naftopidil or Silodosin.
Acronym
The effects of selective alpha-1- adrenergic receptor antagonists in patients with lower urinary tract symptoms caused by benign prostatic hyperplasia. A comparison of Naftopidil or Silodosin.
Scientific Title
The effects of selective alpha-1-adrenergic receptor antagonists in patients with lower urinary tract symptoms caused by benign prostatic hyperplasiawho failed to obtain sufficient efficacy by previous alpha-1-blockades.
. A comparison of Naftopidil or Silodosin.
Scientific Title:Acronym
The effects of selective alpha-1- adrenergic receptor antagonists in patients with lower urinary tract symptoms caused by benign prostatic hyperplasia. A comparison of Naftopidil or Silodosin.
Region
| Japan |
Condition
Condition
Benign Prostatic Hyperplasia
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the safety and efficacy of selective alpha 1 adrenergic receptor antagonists in patients with lower urinary tract symptoms caused by benign prostatic hyperplasia who failed to obtain sufficient efficacy by previous alpha-blockades.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
IPSS score QOL score Blood pressure
Key secondary outcomes
Uroflowmetry
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
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
We assess the clinical efficacy and safety of the loading dosage escalation to naftopidil 75mg in patients with lower urinary tract symptoms caused by benign prostatic hyperplasia who failed to obtain sufficient efficacy by naftopidil 50mg.
Interventions/Control_2
We assess the clinical efficacy and safety of switchover treatment with silodosin 8mg in patients with lower urinary tract symptoms caused by benign prostatic hyperplasia who failed to obtain sufficient efficacy by naftopidil 50mg.
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
Men with lower urinary tract symptoms caused by benign prostatic hyperplasia who failed to obtain sufficient efficacy by naftopidil 50mg and with International Prostate Symptom Score(IPSS) of>=9,a quality-of-life (QOL)score of >=2,a prostate volume of>=20ml are eligible for enrolment.
Key exclusion criteria
none
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigenari Kawakita |
Organization
kansai Medical University Takii Hospital
Division name
Department of Urology
Zip code
Address
10-15 Fumizono, Moriguchi, Osaka, Japan
TEL
06-6992-1001
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kansai Medical University Takii Hospital
Division name
Deaprtment of Urology
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Kansai Medical University Takii Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
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
関西医科大学附属滝井病院
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 05 | 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
Preinitiation
Date of protocol fixation
| 2010 | Year | 03 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 05 | 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
| 2010 | Year | 05 | Month | 13 | Day |
Last modified on
| 2010 | Year | 05 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004331
