|- candidate number||1270|
|- NTR Number||NTR159|
|- Date ISRCTN created||20-dec-2005|
|- date ISRCTN requested||18-okt-2005|
|- Date Registered NTR||29-aug-2005|
|- Secondary IDs||N/A |
|- Public Title||The direct effects of NSAIDS on osteoarthritic knee cartilage. |
|- Scientific Title||Selective COX-2 inhibition is beneficial for matrix turnover: a clinical study.|
|- hypothesis||Selective COX-2 inhibition is beneficial for matrix turnover.|
|- Healt Condition(s) or Problem(s) studied||Arthritis, Osteoarthritis|
|- Inclusion criteria||Patients with knee osteoarthritis according to the ACR criteria, considered for total knee replacement surgery.|
|- Exclusion criteria||1. 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 received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-nov-2004|
|- planned closingdate||1-dec-2005|
|- Target number of participants||42|
|- Interventions||Celecoxib: 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 outcome||Difference in proteoglycan release of osteoarthritic cartilage after treatment.|
|- Secondary outcome||ProsteoglandinE2 levels produced by cartilage.
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||Dr. A.C.A. Marijnissen|
|- CONTACT for SCIENTIFIC QUERIES||Drs. S.C. Mastbergen|
|- Sponsor/Initiator ||University Medical Center Utrecht (UMCU), Department of Rheumatology and Clinical Immunology|
(Source(s) of Monetary or Material Support)
|- Publications||Arthritis Res Ther. 2006;8(1):R2.|
|- Brief summary||Objectives:|
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.
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)|
|- RECORD||22-aug-2005 - 17-sep-2008|