Modulation of the Surgical Inflammatory Response by Etoricoxib: Peripheral versus Central

• Conditions: Patients with osteoarthritis undergoing elective primary single hip arthroplasty

• Registration Number: EUCTR2005-003854-80-DE
• Lead Sponsor: Department of Experimental and Clinical Pharmacology and Toxicology, Friedrich-Alexander-University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01-04
• Last Update Posted: 15 April 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

•Subject undergoing elective primary single hip arthroplasty
•Subject diagnosed with Osteoarthritis / arthrosis
•Age 55 - 80
•Subject has not taken non-steroidal anti-inflammatory drugs within 4 of their half life times prior to enrollment
•Subject capable of understanding and cooperating with the requirements of the study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Patients with renal insufficiency (serum creatinine >1.5 mg/dl)
•Recent major trauma or systemic infection (within 3 months)
•Use of corticosteroid medication or chronic opioids (within 3 months)
•Any other condition likely to affect prostaglandin and cytokine levels
•Participation in another clinical study or receipt of an investigational drug within 30 days
•Hypersensitivity to any component of the etoricoxib and/or placebo tablets
•Uncontrolled hypertension defined as systolic blood pressure >160 mm Hg and diastolic pressure >90 mm Hg at rest after two repeated measurements
•Congestive heart failure (NYHA II-IV)
•Cerebrovascular disease
•Established ischemic heart disease (including patients who have recently undergone coronary artery bypass graft surgery or angioplasty)
•Patients with any kind or severity of cirrhosis of the liver or cholestasis or elevated liver function enzymes (ALT or AST 3 fold) as a sign of clinical significant liver malfunction (corresponds to any Child-Pugh-Score =5)
•Patients who have developed signs of asthma, acute rhinitis, nasal polyps, angioneurotic oedema or urticaria following the administration of aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs)
•Pregnancy and lactation
•Patients with active peptic ulcerations or active gastro-intestinal (GI) bleeding,
•Inflammatory bowel disease
•Recent history (within the last year) of alcohol or other substance abuse
•An employee of the sponsor or study site
•Any neurological syndrome or any other condition leading to contra-indication to spinal anesthesia

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To test the hypothesis that orally administered etoricoxib (COX-2) modulates prostaglandin and cytokine synthesis in the central nervous system (CNS) and in the periphery in surgical patients.;Secondary Objective: To determine the CSF (cerebrospinal fluid), plasma and tissue pharmacokinetics of orally administered etoricoxib.<br>To correlate the prostaglandin and cytokine response to clinical outcome parameters after hip arthroplasty. <br>;Primary end point(s): Decrease of inflammatory mediators in CSF (cerebrospinal fluid), plasma and tissue (hip darin) after orally administered etoricoxib.<br>Decreased Pain Scores at rest and passive movement of the operated hip and/or reduced consumption of other pain medication after etoricoxib administration.<br>