UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000721 |
|---|---|
| Receipt number | 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 14:45:40 |
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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
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
shiken@office.chiba-u.jp
Sponsor or person
Institute
Department of orthopaedic surgery, Graduate school of medicine, Chiba University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000864
