UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004454 |
|---|---|
| Receipt number | R000005331 |
| Scientific Title | Effect of dutasteride for relieving benign prostatic obstruction |
| Date of disclosure of the study information | 2010/10/26 |
| Last modified on | 2017/01/21 11:56:08 |
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Basic information
Public title
Effect of dutasteride for relieving benign prostatic obstruction
Acronym
AVO PFS Study
Scientific Title
Effect of dutasteride for relieving benign prostatic obstruction
Scientific Title:Acronym
AVO PFS Study
Region
| Japan |
Condition
Condition
Benign Prostatic Hyperplasia
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of dutasteride for relieving benign prostatic obstruction (BPO) by pressure flow study (PFS)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change from baseline in PFS parameter
Key secondary outcomes
IPSS
OABSS
Urinary flow
Post voided residual volume
Safety
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Dutasteride 0.5mg/day for 24 months
Interventions/Control_2
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
Subjects who meet all the following criteria will be enrolled.
1 Age >= 50 yrs
2 IPSS >= 8
3 IPSS QOL >= 3
4 Prostate volume >= 25mL measured by abdominal ultarsonograpy
5 Qmax < 15mL/sec
Key exclusion criteria
Subjects who apply to any of the following criteria will not be enrolled.
1 Use of any alpha-blocker within 4 weeks
2 Previous use of 5ARIs or antiandrogens
3 History of prostate cancer
4 History of acute urinary retention (AUR) within 3 months
5 Previous prostatic surgery
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshihisa Matsukawa |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Urology
Zip code
Address
65 Tsuruma-Cho, Showa-Ku, Nagoya, 466-8550, Japan
TEL
+81-52-744-2985
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshihisa Matsukawa |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Urology
Zip code
Address
65 Tsuruma-Cho, Showa-Ku, Nagoya, 466-8550, Japan
TEL
+81-52-744-2985
Homepage URL
yoshi44@med.nagoya-u.ac.jp
Sponsor or person
Institute
Department of Urology, Nagoya University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
GlaxoSmithKline
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
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 10 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Dutasteride was effective for relieving LUTS by improving storage and voiding function as well as subjective symptoms in patients with BPH.
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
| 2010 | Year | 07 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 01 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 01 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 01 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 10 | Month | 26 | Day |
Last modified on
| 2017 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005331
