UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000979 |
|---|---|
| Receipt number | R000001174 |
| Scientific Title | Efficacy of Non-Steroidal Anti-Inflammatory Drugs before cystoscopy |
| Date of disclosure of the study information | 2008/02/28 |
| Last modified on | 2011/02/13 12:51:05 |
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Basic information
Public title
Efficacy of Non-Steroidal Anti-Inflammatory Drugs before cystoscopy
Acronym
NSAIDS for cystoscopy
Scientific Title
Efficacy of Non-Steroidal Anti-Inflammatory Drugs before cystoscopy
Scientific Title:Acronym
NSAIDS for cystoscopy
Region
| Japan |
Condition
Condition
Urothelial cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To analyze efficacy of Non-Steroidal Anti-Inflammatory Drugs before cystoscopy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
We analyze whether pain associated with cystocopy can be decreased or not
Key secondary outcomes
If pain is decreased, we analyze which drug is more potent, which order is better, or whether patients hope to continue taking drugs before cystoscopy
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
25 cases
no-drug at 1st cystoscopy->3 months->Zaltoprofen at 2nd cystostopy->3 months->Loxoprofen at 3rd cystoscopy
Interventions/Control_2
25 cases
no-drug at 1st cystoscopy->3 months->Loxoprofen at 2nd cystostopy->3 months->Zaltoprofen at 3rd cystoscopy
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
Patients who under follow-up by periodic cystoscopy for urothelial cancer after treatment without chemotherapy
Key exclusion criteria
those who are under chemotherapy
those who are contraindication for Zaltoprofen or Loxoprofen
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yukio Naya |
Organization
Chiba University Hospital
Division name
Department of Urology
Zip code
Address
1-8-1 Inohana, chuo-ku, Chiba-shi
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira Komiya |
Organization
University of Toyama
Division name
Department of Urology
Zip code
Address
TEL
Homepage URL
akirakomiya@mac.com
Sponsor or person
Institute
Chiba University Hospital
Institute
Department
Personal name
Funding Source
Organization
Chiba University Hospital
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
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 02 | Month | 28 | 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
| 2006 | Year | 04 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 03 | 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 | 09 | 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=R000001174
