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Disease modifying activity of celecoxib on articular cartilage in osteoarthritis

Completed
Conditions
artrose
osteoarthritis
Registration Number
NL-OMON30920
Lead Sponsor
Sint Franciscus Gasthuis
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
172
Inclusion Criteria

Patients with knee osteoarthritis, who are eligible for and on the waiting list for total knee replacement surgery. Patients will be treated at the Sint Franciscus Gasthuis Hospital in Rotterdam.

Exclusion Criteria

Patients who are eligible for a total knee replacement operation for other reasons than osteoarthritis.
Patients with an increased risk of gastro-intestinal bleeding.
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; patients with untreated/insufficiently treated hypertension; patients with angina pectoris and patients on oral anticoagulants.
Patients with serious liver and/or kidney function impairment.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>The primary outcome parameter is the difference in proteoglycan release of the<br /><br>OA cartilage under the influence of treatment. </p><br>
Secondary Outcome Measures
NameTimeMethod
<p>The secondary outcome parameters are changes in several biochemical and<br /><br>histochemical characteristics of the OA cartilage including proteoglycan<br /><br>synthesis rate, proteoglycan content, prostaglandin E2 (PGE2) production, and<br /><br>COX-1 and COX-2 expression of cartilage.<br /><br>The tertiary outcome measures are changes in synovial tissue due to treatment<br /><br>measured by biochemical and histochemical techniques, including IL-1 and TNFa<br /><br>production, COX expression, and protease activity.</p><br>
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