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Disease modifying activity of celecoxib on articular cartilage in osteoarthritis.

Disease modifying activity of celecoxib on articular cartilage in osteoarthritis.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON25692
Enrollment
172
Registered
2008-12-11
Start date
2007-12-07
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

end stage knee osteoarthritis

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.

Sponsors

Sint Franciscus Gasthuis hospital Rotterdam
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Difference in proteoglycan release of the OA cartilage under the influence of celecoxib.

Secondary

MeasureTime frame
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.

Contacts

Public ContactT.N. Boer, de

UMC Utrecht PO Box 85500, F02.127

+31.88.7559428

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)