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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000008138 |
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Date of registration:
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01/07/2012 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Efficacy and safety of silodosin on lower urinary tract symptoms (LUTS) in patients with Parkinson's disease
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Scientific title:
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Efficacy and safety of silodosin on lower urinary tract symptoms (LUTS) in patients with Parkinson's disease - Efficacy and safety of silodosin on lower urinary tract symptoms (LUTS) in patients with Parkinson's disease |
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Date of first enrolment:
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2012/07/01 |
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Target sample size:
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100 |
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Recruitment status: |
Complete: follow-up complete |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009579 |
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Study type:
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Interventional |
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Study design:
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Single arm Non-randomized
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Phase:
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Not selected
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Countries of recruitment
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Japan
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Contacts
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Name:
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Yasushi Shimo |
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Address:
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2-1-1 Bunkyo-ku Hongo Tokyo Japan
Japan |
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Telephone:
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Email:
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Affiliation:
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Juntendo University School of Medicine Department of Neurology |
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Name:
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Genko Oyama |
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Address:
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2-1-1 Bunkyo-ku Hongo Tokyo Japan
Japan |
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Telephone:
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Email:
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Affiliation:
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Juntendo University School of Medicine Department of Neurology |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: Patients who 1) is taking other alpha 1-blockers (Harnal, Flivas), or who cannot do washout taking these drugs 2) had taken anti-androgens or 5 alpha-reductase inhibitors 6 months before the informed consent 3) cannot quit concomitant medications. 4) Cannot record subjective symptoms because of dementia etc. (23>=MMSE) 5) have had surgical treatment such as TURP, thermo thrapy, HoLEP etc. 6) primary physician judged as inadequate to entry in this study
Age minimum:
Not applicable
Age maximum:
Not applicable
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Parkinson's disease
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Intervention(s)
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Silodosin 8mg BID
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Primary Outcome(s)
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Changes in IPSS total score before and after administration of silodosin
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Secondary Outcome(s)
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QOL score, OABSS, Blood pressure, Adverse events
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Source(s) of Monetary Support
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None
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Ethics review
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Status: YES
Approval date:
Contact:
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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01/06/2014 |
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URL:
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