UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003172 |
|---|---|
| Receipt number | R000003836 |
| Scientific Title | Clinacal study on the intravesical instillation of dimethylsulfoxide (DMSO) for the patients with interstitial cystitis |
| Date of disclosure of the study information | 2010/02/12 |
| Last modified on | 2018/02/27 17:45:30 |
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Basic information
Public title
Clinacal study on the intravesical instillation of dimethylsulfoxide (DMSO) for the patients with interstitial cystitis
Acronym
DMSO for interstitial cystitis
Scientific Title
Clinacal study on the intravesical instillation of dimethylsulfoxide (DMSO) for the patients with interstitial cystitis
Scientific Title:Acronym
DMSO for interstitial cystitis
Region
| Japan |
Condition
Condition
Interstitial cystitis
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect and adverse events of the treatment with DMSO intravesical instillation for the patients with interstitial cystitis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
urinary frequency, bladder pain
Key secondary outcomes
QOL
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
Intravesical instillation of DMSO
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
interstitial cystitis
Key exclusion criteria
patients with cystitis other than interstitial cystitis or patients with bladder neoplasms
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Osamu Yokoyama |
Organization
University of Fukui
Division name
Department of Urology, Faculty of Medical Science
Zip code
Address
23-3 Matsuokashimoaizuki, Eiheiji, Yoshida, Fukui, 9101193 Japan
TEL
0776-61-8399
oyoko@u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Osamu Yokoyama |
Organization
University of Fukui
Division name
Department of Urology, Faculty of Medical Science
Zip code
Address
23-3 Matsuokashimoaizuki, Eiheiji, Yoshida, Fukui, 9101193 Japan
TEL
0776-61-8399
Homepage URL
http://www.hosp.u-fukui.ac.jp/09okusuri/chise/chise_index.html
oyoko@u-fukui.ac.jp
Sponsor or person
Institute
Deparment of Urology, Medical Science, University of Fukui
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
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
福井大学病院（福井県）、University of Fukui Hospital (Fukui)
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 02 | Month | 12 | 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
Open public recruiting
Date of protocol fixation
| 2005 | Year | 05 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 02 | Month | 12 | Day |
Last modified on
| 2018 | Year | 02 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003836
