UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000982 |
|---|---|
| Receipt number | R000001175 |
| Scientific Title | Effect of Naftpidil to generic QOL |
| Date of disclosure of the study information | 2008/02/01 |
| Last modified on | 2011/02/13 12:52:21 |
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Basic information
Public title
Effect of Naftpidil to generic QOL
Acronym
Effect of Naftpidil to generic QOL
Scientific Title
Effect of Naftpidil to generic QOL
Scientific Title:Acronym
Effect of Naftpidil to generic QOL
Region
| Japan |
Condition
Condition
LUTS/BPH
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To analyze Effect of Naftpidil to generic QOL
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Whether Naftpidil affects generic QOL; which sub-domain is mostly affected?
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
100 cases;
Quastionnaires for urinary symptoms(IPSS) and generic QOL(SF-8) are anwered before, after 4 and 8 weeks taking Naftpidil.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
Those who have LUTS/BPH and are considered for medical treatment
Key exclusion criteria
contraindication for Naftpidil
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira Komiya |
Organization
Faculty of Medicine, University of Toyama
Division name
Department of Urology
Zip code
Address
2630 Sugitani, Toyama-shi
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira Komiya |
Organization
Faculty of Medicine, University of Toyama
Division name
Department of Urology
Zip code
Address
TEL
Homepage URL
akirakomiya@mac.com
Sponsor or person
Institute
Chiba Investigation Group of Urinary Disorder and QOL
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
千葉大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2007 | Year | 01 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 02 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 02 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 02 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 01 | Month | 11 | Day |
Last modified on
| 2011 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001175
