|- candidate number||4715|
|- NTR Number||NTR1579|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd |
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||11-dec-2008|
|- Secondary IDs||2007/36 METC Rotterdam|
|- Public Title||Disease modifying activity of celecoxib on articular cartilage in osteoarthritis.|
|- Scientific Title||Disease modifying activity of celecoxib on articular cartilage in osteoarthritis.|
|- ACRONYM||Disease modifying activity of celecoxib.|
|- hypothesis||Celecoxib, 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) studied||Osteoarthritis, Knee|
|- Inclusion criteria||Patients with knee osteoarthritis eligible for and on the waiting list for total knee replacement surgery at the Sint Fransiscus Gasthuis hospital in Rotterdam. |
|- Exclusion criteria||1. 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 received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||7-dec-2007|
|- planned closingdate||31-aug-2009|
|- Target number of participants||172|
|- Interventions||a. 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 outcome||Difference in proteoglycan release of the OA cartilage under the influence of celecoxib.|
|- Secondary outcome||Changes 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.|
|- Timepoints||First visit: at least 5 weeks before surgery.|
Second visit: day of surgery.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Drs. T.N. Boer, de|
|- CONTACT for SCIENTIFIC QUERIES||Drs. T.N. Boer, de|
|- Sponsor/Initiator ||Sint Franciscus Gasthuis (SFG) |
(Source(s) of Monetary or Material Support)
|University Medical Center Utrecht (UMCU)|
|- Brief summary||The 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)|
|- RECORD||11-dec-2008 - 12-jan-2009|