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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017481
Receipt No. 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

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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
Email 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
Email rainbow-quest@pop02.odn.ne.jp

Sponsor
Institute Department of Orthopaedic Surgery, Hokkaido University Graduate School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020262

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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