UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003649 |
|---|---|
| Receipt number | R000004104 |
| Scientific Title | The clinical effect of Cyclooxygenase (COX)-2 selective inhibitors on pollakisuria and lumbar- abdominal pain in patients with prostate cancer who undergo interstitial seed implantation - Randomized control trial- |
| Date of disclosure of the study information | 2010/05/21 |
| Last modified on | 2018/05/29 19:36:34 |
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Basic information
Public title
The clinical effect of Cyclooxygenase (COX)-2 selective inhibitors on pollakisuria and lumbar- abdominal pain in patients with prostate cancer who undergo interstitial seed implantation - Randomized control trial-
Acronym
The clinical effect of Cox-2 inhibitor on symptoms in patients who undergo prostate brachytherapy
Scientific Title
The clinical effect of Cyclooxygenase (COX)-2 selective inhibitors on pollakisuria and lumbar- abdominal pain in patients with prostate cancer who undergo interstitial seed implantation - Randomized control trial-
Scientific Title:Acronym
The clinical effect of Cox-2 inhibitor on symptoms in patients who undergo prostate brachytherapy
Region
| Japan |
Condition
Condition
prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to assess the clinical effect of COX-2 inhibitor on pallakisuria and lumbar-abdominal pain in patients who undergo prostate brachytherapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement of rate in IPSS, QOL-index, OABSS and QOL questionnaire (SF8 and EPIC) during 3 months after seed implantation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
alpha-1 blocker
Interventions/Control_2
alpha-1 blocker + COX-2 inhibitor
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
newly diagnosed localized prostate cancer patients
Key exclusion criteria
Patients with severe cardiac disease, severe liver dysfunction and severe renal dysfunction
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobumichi Tanaka |
Organization
Nara Medical University
Division name
Department of Urology
Zip code
Address
Shijyocho840, Kashihara, Japan
TEL
0744-22-3051
sendo@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobumichi Tanaka |
Organization
Nara Medical University
Division name
Department of Urology
Zip code
Address
Shijyocho840, Kashihara, Japan
TEL
0744-22-3051
Homepage URL
sendo@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
Nara Medical University
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
| 2010 | Year | 05 | Month | 21 | 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
Main results already published
Date of protocol fixation
| 2010 | Year | 03 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
| 2014 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 05 | Month | 21 | Day |
Last modified on
| 2018 | Year | 05 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004104
