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Disease modifying activity of celecoxib on articular cartilage in osteoarthritis

Disease modifying activity of celecoxib on articular cartilage in osteoarthritis - Disease modifying activity of celecoxib

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON30920
Enrollment
172
Registered
2007-11-05
Start date
2007-12-14
Completion date
Unknown
Last updated
2024-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

artrose osteoarthritis

Interventions

One group receives no treatment for 4 weeks, the second group receives 2x daily 200mg celecoxib for 4 weeks until surgery, the third group receives 2x daily 200mg celecoxib for 4 weeks until 3 days

Sponsors

Sint Franciscus Gasthuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
The primary outcome parameter is the difference in proteoglycan release of the OA cartilage under the influence of treatment.

Secondary

MeasureTime frame
The secondary outcome parameters are changes in several biochemical and histochemical characteristics of the OA cartilage including proteoglycan synthesis rate, proteoglycan content, prostaglandin E2 (PGE2) production, and COX-1 and COX-2 expression of cartilage. The tertiary outcome measures are changes in synovial tissue due to treatment measured by biochemical and histochemical techniques, including IL-1 and TNFa production, COX expression, and protease activity.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)