UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008138 |
|---|---|
| Receipt number | R000009579 |
| Scientific Title | Efficacy and safety of silodosin on lower urinary tract symptoms (LUTS) in patients with Parkinson's disease |
| Date of disclosure of the study information | 2012/07/01 |
| Last modified on | 2015/07/10 07:25:01 |
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Basic information
Public title
Efficacy and safety of silodosin on lower urinary tract symptoms (LUTS) in patients with Parkinson's disease
Acronym
Efficacy and safety of silodosin on lower urinary tract symptoms (LUTS) in patients with Parkinson's disease
Scientific Title
Efficacy and safety of silodosin on lower urinary tract symptoms (LUTS) in patients with Parkinson's disease
Scientific Title:Acronym
Efficacy and safety of silodosin on lower urinary tract symptoms (LUTS) in patients with Parkinson's disease
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The actual condition of a Parkinson's patient's urination trouble is investigated, and the validity and the safety of alfa1-blocker silodosin are examined in the male Parkinson's patient who has shown lower urinary tract condition.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in IPSS total score before and after administration of silodosin
Key secondary outcomes
QOL score, OABSS, Blood pressure, Adverse events
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
Silodosin 8mg BID
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
1) Male Parkinson's disease patients
2) IPSS>=8 and QOL>=3
3) Patients who accepted to attend in this study with informed consent
Key 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
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasushi Shimo |
Organization
Juntendo University School of Medicine
Division name
Department of Neurology
Zip code
Address
2-1-1 Bunkyo-ku Hongo Tokyo Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Genko Oyama |
Organization
Juntendo University School of Medicine
Division name
Department of Neurology
Zip code
Address
2-1-1 Bunkyo-ku Hongo Tokyo Japan
TEL
Homepage URL
Sponsor or person
Institute
Juntendo University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
順天堂大学医学部附属順天堂医院（東京都）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 07 | 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
Completed
Date of protocol fixation
| 2012 | Year | 05 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 06 | Month | 11 | Day |
Last modified on
| 2015 | Year | 07 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009579
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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