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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000004454 |
Receipt No. | 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 |
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 |
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Condition | ||
Condition | Benign Prostatic Hyperplasia | |
Classification by specialty |
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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 |
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Interventions/Control_1 | Dutasteride 0.5mg/day for 24 months | |
Interventions/Control_2 | ||
Interventions/Control_3 | ||
Interventions/Control_4 | ||
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Interventions/Control_6 | ||
Interventions/Control_7 | ||
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Interventions/Control_9 | ||
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 60 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | Department of Urology, Nagoya University School of Medicine |
Institute | |
Department |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry |
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Date trial data considered complete |
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Date analysis concluded |
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Other | |
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Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005331 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |