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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000000721
Receipt No. R000000864
Scientific Title Effects of NSAIDS on activities of cartilage degrading enzymes in osteoarthritic knees
Date of disclosure of the study information 2008/03/31
Last modified on 2016/11/28

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Basic information
Public title Effects of NSAIDS on activities of cartilage degrading enzymes in osteoarthritic knees
Acronym NSAIDS and OA cartilage degradation
Scientific Title Effects of NSAIDS on activities of cartilage degrading enzymes in osteoarthritic knees
Scientific Title:Acronym NSAIDS and OA cartilage degradation
Region
Japan

Condition
Condition Osteoarthritis of the knee
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Osteoarthritis of the knee (OA) is one of major diseases that cause ADL disturbances of the elder. OA causes several joint dysfunctions but among them knee pain is the biggest problem for patients. Therefore, NSAIDS prescription is one of common therapy. NSAIDS is effective for about 60 to 70 percent of patients but its action against normal cartilage metabolism is a concern because they may enhance cartilage degradation. Activities against Cyclooxygenase-1 (COX-1) is thought be main cause for this. Desirable action of NSAIDS is attributable on its COX-2 prohibition but inevitably NSAIDS prohibit both COX-1 and COX-2. Recently new NSAIDS that preferentially prohibit COX-2 are on market. Those new NSAIDS are not affecting normal cartilage metabolism much and moreover potentially protect cartilage from degradation. 1) Increased production of ECM and 2) Suppression of MMP activities are reported. So in the present study effects of NSAIDS on cartilage degrading enzymes will be studied.
Basic objectives2 Pharmacodynamics
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes MMP-3,9,13 and TIMP-1,2 of joint fluid
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Diclofenac (COX-1 and 2 supressor)
Interventions/Control_2 Meloxicam (selective COX-2 supressor)
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
55 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria Osteoarthritic knees that require joint punctuation or joint injection on regular basis
Key exclusion criteria 1) Gastric ulcer
2) Liver disfunction
3) Uncontrolled hypertension
4) Allergy against aspirin
5) Asthma indeuced by aspirin
6) Pregnancy
7) Other condtitions that are not suitable for the study judged by medical doctors
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name TAKAHISA SASHO
Organization Graduate school of medicine, Chiba University
Division name Department of orthopaedic surgery
Zip code
Address 1-8-1, Inohana, Cyuou, Chiba
TEL 043-226-2117
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Graduate school of medicine, Chiba University
Division name Department of orthopaedic surgery
Zip code
Address
TEL
Homepage URL
Email shiken@office.chiba-u.jp

Sponsor
Institute Department of orthopaedic surgery, Graduate school of medicine, Chiba University
Institute
Department

Funding Source
Organization Department of orthopaedic surgery, Graduate school of medicine, Chiba University
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
2008 Year 03 Month 31 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 Terminated
Date of protocol fixation
2007 Year 04 Month 16 Day
Date of IRB
Anticipated trial start date
2007 Year 06 Month 01 Day
Last follow-up date
2010 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2007 Year 05 Month 23 Day
Last modified on
2016 Year 11 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000864

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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