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Disease modifying activity of celecoxib on articular cartilage in osteoarthritis.


- candidate number4715
- NTR NumberNTR1579
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-dec-2008
- Secondary IDs2007/36 METC Rotterdam
- Public TitleDisease modifying activity of celecoxib on articular cartilage in osteoarthritis.
- Scientific TitleDisease modifying activity of celecoxib on articular cartilage in osteoarthritis.
- ACRONYMDisease modifying activity of celecoxib.
- hypothesisCelecoxib, as a selective COX-2 inhibitor, has in vivo disease modifying activity in addition to its inflammation regulatory properties, in comparison to naproxen as a conventional non-selective NSAID.
- Healt Condition(s) or Problem(s) studiedOsteoarthritis, Knee
- Inclusion criteriaPatients with knee osteoarthritis eligible for and on the waiting list for total knee replacement surgery at the Sint Fransiscus Gasthuis hospital in Rotterdam.
- Exclusion criteria1. Patients who are eligible for a total knee replacement operation for other reasons than OA;
2. Patients with an increased risk for gastro-intestinal bleeding;
3. Patients with an increased risk of cardio-vascular disease such as a history of cardio-vascular disease like myocardium infarct, heart failure, CVA and TIA;
4. Patients with untreated/insufficiently treated hypertension;
5. Patients with angina pectoris and patients on oral anticoagulants;
6. Patients with serious liver and/or kidney function impairment;
7. Patients with intolerance for naproxen.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 7-dec-2007
- planned closingdate31-aug-2009
- Target number of participants172
- Interventionsa. 4 weeks no treatment;
b. 4 weeks 2x daily 200 mg celecoxib/Celebrex until the surgery;
c. 4 weeks 2x daily 200 mg celecoxib/Celebrex until 3 days before surgery;
d. 4 weeks 3x daily 250 mg.
Naproxen/Aleve until 3 days before surgery.
- Primary outcomeDifference in proteoglycan release of the OA cartilage under the influence of celecoxib.
- Secondary outcomeChanges in several biochemical and histochemical characteristics of the OA cartilage including proteoglycan synthesis rate, proteoglycan content, prostaglandin E2 production, and COX-1 and COX-2 expression of cartilage.
- TimepointsFirst visit: at least 5 weeks before surgery.
Second visit: day of surgery.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs. T.N. Boer, de
- CONTACT for SCIENTIFIC QUERIESDrs. T.N. Boer, de
- Sponsor/Initiator Sint Franciscus Gasthuis (SFG)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Utrecht (UMCU)
- Publications
- Brief summaryThe objective of the study is to evaluate, in patients with end stage knee osteoarthritis, the in vivo disease (tissue structure) modifying activity of celecoxib, as a selective COX-2 inhibitor, in addition to its inflammation regulatory properties, compared to naproxen as a conventional non-selective NSAID.
This is a blind randomized controlled study. Patients with knee osteoarthritis, who are eligible for and on the waiting list for total knee replacement surgery are asked to participate. Patients will be assigned to one of the four groups:
One group receives no treatment for 4 weeks, the second group receives 2x daily 200 mg celecoxib for 4 weeks until surgery, the third group receives 2 x daily 200 mg celecoxib for 4 weeks until 3 days before the surgery and the fourth group receives 3 x daily 250 mg naproxen for 4 weeks until 3 days before the surgery. Each group will consist of 43 patients.
Before trial medication starts and at the day of surgery a sample of blood and urine will be taken for biomarker analysis. In addition a WOMAC questionnaire and VAS pain will be evaluated at these timepoints. The knee replacement surgery will take place as scheduled. Cartilage and synovial tissue that are removed as standard procedure during replacement surgery will be used for analyses to evaluate the disease modifying activity in the four groups.
- Main changes (audit trail)
- RECORD11-dec-2008 - 12-jan-2009


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