Patients with osteoarthritis undergoing elective primary single hip arthroplasty
Conditions
Interventions
Product Name: Etoricoxib 60 mg (MK-0663)
Pharmaceutical Form: Film-coated tablet
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Sponsors
Department of Experimental and Clinical Pharmacology and Toxicology, Friedrich-Alexander-University
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. To correlate the prostaglandin and cytokine response to clinical outcome parameters after hip arthroplasty. ;Primary end point(s): Decrease of inflammatory mediators in CSF (cerebrospinal fluid), plasma and tissue (hip darin) after orally administered etoricoxib. Decreased Pain Scores at rest and passive movement of the operated hip and/or reduced consumption of other pain medication after etoricoxib administration. | — |
Countries
Germany
Outcome results
None listed