UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017481 |
|---|---|
| Receipt number | R000020262 |
| Scientific Title | Effect of COX-2 selective inhibitor to synovial fluids and synovial tissues of osteoarthritis of the knee at total knee replacement. |
| Date of disclosure of the study information | 2015/05/15 |
| Last modified on | 2015/05/10 00:15:56 |
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Basic information
Public title
Effect of COX-2 selective inhibitor to synovial fluids and synovial tissues of osteoarthritis of the knee at total knee replacement.
Acronym
Effect of COX-2 selective inhibitor to synovial fluids and synovial tissues of osteoarthritis of the knee.
Scientific Title
Effect of COX-2 selective inhibitor to synovial fluids and synovial tissues of osteoarthritis of the knee at total knee replacement.
Scientific Title:Acronym
Effect of COX-2 selective inhibitor to synovial fluids and synovial tissues of osteoarthritis of the knee.
Region
| Japan |
Condition
Condition
Osteoarthritis of the knee
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effects of a selective COX-2 inhibitor, celecoxib, and a dual COX inhibitor, diclofenac sodium in synovial fluids and syonovial tissues with severe knee osteoarthritis patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To measure protein presence of cytokines and HA concentration in the synovial fluids.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
celecoxib group
Interventions/Control_2
diclofenac sodium group
Interventions/Control_3
control group
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
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Severe knee OA who were performed the total knee arthroplasty surgery.
Key exclusion criteria
Total knee arthroplasty for other reasons, patient with history of gastrointestinal bleedings or perforation.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tokifumi Majima |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Joint Replacement and Tissue Engineering
Zip code
Address
Kita-15, Nishi-7, Kita-ku, Sapporo
TEL
011-706-5935
tkmajima@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daisuke Takahashi |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Orthopaedic Surgery,
Zip code
Address
Kita-15, Nishi-7, Kita-ku, Sapporo
TEL
011-706-5936
Homepage URL
rainbow-quest@pop02.odn.ne.jp
Sponsor or person
Institute
Department of Orthopaedic Surgery, Hokkaido University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
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
| 2015 | Year | 05 | Month | 15 | 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
| 2008 | Year | 08 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 05 | Month | 10 | Day |
Last modified on
| 2015 | Year | 05 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020262
