UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025443 |
|---|---|
| Receipt number | R000029283 |
| Scientific Title | Investigation of short-term efficacy and safety of 5-alpha reductase inhibitor in the patients with BPH |
| Date of disclosure of the study information | 2016/12/27 |
| Last modified on | 2016/12/27 21:22:20 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Investigation of short-term efficacy and safety of 5-alpha reductase inhibitor in the patients with BPH
Acronym
Investigation of short-term efficacy and safety of 5-alpha reductase inhibitor in the patients with BPH
Scientific Title
Investigation of short-term efficacy and safety of 5-alpha reductase inhibitor in the patients with BPH
Scientific Title:Acronym
Investigation of short-term efficacy and safety of 5-alpha reductase inhibitor in the patients with BPH
Region
| Japan |
Condition
Condition
BPH
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of short-term efficacy and safety of 5-alpha reductase inhibitor in the patients with BPH
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cost-effectiveness of dutasteride
Key secondary outcomes
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
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Group 1: dutasteride + tamsulosin
IPSS, VAS, uroflowmetry, PVR, and Prostate volume at week 1, 2, 4, 6, 8, 10, and 12
Interventions/Control_2
Group 2: tamsulosin only
IPSS, VAS, uroflowmetry, PVR, and Prostate volume at week 1, 2, 4, 6, 8, 10, and 12
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
BPH
IPSS 8 and more
Qmax 15 mL/s and more
Prostate volume 30 mL and more
Key exclusion criteria
PSA 10ng/mL and more
Prostate cancer
Surgery for prostate in the last 3 months
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akihide Hirayama |
Organization
Nara Medical University
Division name
Urology
Zip code
Address
840 Shijo-cho, Kashihara, Nara
TEL
0744-22-3051
hirayamn@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kiyohide Fujimoto |
Organization
Nara Medical University
Division name
Urology
Zip code
Address
840 Shijo-cho, Kashihara, Nara
TEL
0744-22-3051
Homepage URL
kiyokun@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
Nara Medical University
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
| 2016 | Year | 12 | Month | 27 | 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 | 02 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 03 | 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
| 2016 | Year | 12 | Month | 27 | Day |
Last modified on
| 2016 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029283
