UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001734 |
|---|---|
| Receipt number | R000002087 |
| Scientific Title | The study of gene polymorphisms and urinary prostaglandins in relation to the development of the overactive bladder |
| Date of disclosure of the study information | 2009/02/25 |
| Last modified on | 2010/02/26 09:41:48 |
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Basic information
Public title
The study of gene polymorphisms and urinary prostaglandins in relation to the development of the overactive bladder
Acronym
The study of gene polymorphisms and urinary prostaglandins in relation to the development of the overactive bladder
Scientific Title
The study of gene polymorphisms and urinary prostaglandins in relation to the development of the overactive bladder
Scientific Title:Acronym
The study of gene polymorphisms and urinary prostaglandins in relation to the development of the overactive bladder
Region
| Japan |
Condition
Condition
Overactive bladder
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To evaluate clinical usefulness of urinary mediator in diagnosis of neurogenic overactive bladder, and to assess the relationship between the development of overactive bladder and SNPs in the COX2 gene
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of the relationship among neurogenic overactive bladder, urinary mediator levels, and SNPs in the COX2 gene.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 and Female
Key inclusion criteria
Patients with neurological diseases
Key exclusion criteria
1) Patients with urinary tract infection
2) Patients who are treated with non-steroid-anti-inflammatory-drugs,
antimuscarinics and alfa-1-blockers
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Osamu Yokoyama |
Organization
Faculty of Medical Science, University of Fukui
Division name
Urology
Zip code
Address
23-3 Matsuokashimoaizuki, Eiheiji-cho, Fukui
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroki Yamauchi |
Organization
Faculty of Medical Science, University of Fukui
Division name
Urology
Zip code
Address
23-3 Matsuokashimoaizuki, Eiheiji-cho, Fukui
TEL
0776-61-8399
Homepage URL
yamahiro@u-fukui.ac.jp
Sponsor or person
Institute
Department of Urology, Faculty of Medical Science, University of Fukui
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports,
Science and Technology (Grant-in-Aid for Scientific research)
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Koshi Rehabilitation Hospital
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
| 2009 | Year | 02 | Month | 25 | 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
No longer recruiting
Date of protocol fixation
| 2006 | Year | 08 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Urinary prostaglandin levels
Management information
Registered date
| 2009 | Year | 02 | Month | 25 | Day |
Last modified on
| 2010 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002087
