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The direct effects of NSAIDS on osteoarthritic knee cartilage.


- candidate number1270
- NTR NumberNTR159
- ISRCTNISRCTN90366351
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR29-aug-2005
- Secondary IDsN/A 
- Public TitleThe direct effects of NSAIDS on osteoarthritic knee cartilage.
- Scientific TitleSelective COX-2 inhibition is beneficial for matrix turnover: a clinical study.
- ACRONYMN/A
- hypothesisSelective COX-2 inhibition is beneficial for matrix turnover.
- Healt Condition(s) or Problem(s) studiedArthritis, Osteoarthritis
- Inclusion criteriaPatients with knee osteoarthritis according to the ACR criteria, considered for total knee replacement surgery.
- Exclusion criteria1. Total knee replacement for other reason than osteoarthritis;
2. History of gastro-intestinal bleedings or perforation;
3. Increased risk for cardiovascular diseases (cardiovascular diseases in history, patients with untreated hypertension, patients with angina pectoris, and patients on oral anticoagulantia).
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-nov-2004
- planned closingdate1-dec-2005
- Target number of participants42
- InterventionsCelecoxib: 4 weeks, 2 times per day, 200 mg;
Naproxen: 4 weeks, 3 times per day, 250 mg;
Indomethacin: 4 weeks, 2 times per day, 50 mg.
- Primary outcomeDifference in proteoglycan release of osteoarthritic cartilage after treatment.
- Secondary outcomeProsteoglandinE2 levels produced by cartilage.
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESDr. A.C.A. Marijnissen
- CONTACT for SCIENTIFIC QUERIESDrs. S.C. Mastbergen
- Sponsor/Initiator University Medical Center Utrecht (UMCU), Department of Rheumatology and Clinical Immunology
- Funding
(Source(s) of Monetary or Material Support)
[default]
- PublicationsArthritis Res Ther. 2006;8(1):R2.
- Brief summaryObjectives:
Selective COX-2 inhibitors are prescribed for many disorders including osteoarthritis (OA), a degenerative joint disease with an incidence exceeding 10% of the adult population.
Recent in vitro studies showed a positive direct effect of celecoxib, one of the selective COX-2 inhibitors, on human OA cartilage. Such effects are difficult to verify in a clinical trial because changes in OA cartilage, degenerative and reparative, are slow and evaluation of articular cartilage by imaging techniques is still hampered by their limited sensitivity.
Therefore, an approach is used in which the benefits of in vivo treatment are combined with the benefits of ex vivo biochemical analyses of the cartilage.


Methods:
Patients with knee OA are treated 4 weeks prior to scheduled knee replacement surgery with celecoxib 2dd200mg, naproxen 3dd250mg, or indomethacin 2dd50mg. During surgery cartilage is collected and analyzed ex vivo.
- Main changes (audit trail)
- RECORD22-aug-2005 - 17-sep-2008


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