UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015311 |
|---|---|
| Receipt number | R000017810 |
| Scientific Title | Efficacy of Alpha-Blocker Add-on Therapy to Tadarafil Treated Men with Lower Urinary Tract Sympton |
| Date of disclosure of the study information | 2014/10/01 |
| Last modified on | 2019/04/05 21:29:57 |
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Basic information
Public title
Efficacy of Alpha-Blocker Add-on Therapy to Tadarafil Treated Men with Lower Urinary Tract Sympton
Acronym
Efficay of Alpha-Blocker Add-on Therapy to Tadarafil
Scientific Title
Efficacy of Alpha-Blocker Add-on Therapy to Tadarafil Treated Men with Lower Urinary Tract Sympton
Scientific Title:Acronym
Efficay of Alpha-Blocker Add-on Therapy to Tadarafil
Region
| Japan |
Condition
Condition
benign prostatic hypertrophy
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy of alpha-blocker plus tadarafil in men with lower urinary tract sympton after tadarafil monotherapy.
Basic objectives2
Others
Basic objectives -Others
Efficay and safety of alpha1A-specific blocker vs alpha1D-specific blocker is also evaluated.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
OABSS, IPSS and urodynamic parameter such as Qmax and residual volue of urine.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
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
The patients were randomly divided into two groups: alpha1A blocker add-on group or alpha1D blocker add-on group.Patients in each group were administered drugs for 6 weeks. Following 2-week drug withdrawal period, the drug was changed and administered for another 6 weeks.
Interventions/Control_2
The patients were randomly divided into two groups: the silodosin add-on group or naftpidil add-on group.Patients in each group were administered drugs for 6 weeks. Following 2-week drug withdrawal period, the drug was changed and administered for another 6 weeks.
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. Prostate volume > 20cc
2. LUTS sympton (IPPS>8 and Qmax 5-15ml/sec) after taking tadarafil for 3 or more months.
Key exclusion criteria
1. Prostate cancer
2. Episode of urinary retention within 6 months
3. Residual urine volume >150ml
4. Urinary tract infection, neurogenic bladder
Target sample size
58
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryuichi Mizuno |
Organization
Keio University School of Medicine
Division name
Department of Urology
Zip code
Address
35 Shinanomachi, Shinjyuku, Tokyo
TEL
03-3353-1211
mizunor@z7.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshiaki Shinojima |
Organization
Keio University School of Medicine
Division name
Department of Urology
Zip code
Address
35 Shinanomachi, Shinjyuku, Tokyo
TEL
03-3353-1211
Homepage URL
t-shinoj@cd5.so-net.ne.jp
Sponsor or person
Institute
Department of Urology, Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Urology, Keio University School of Medicine
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 10 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2014 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 04 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 10 | Month | 01 | Day |
Last modified on
| 2019 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017810
