Modulation of the Surgical Inflammatory Response by Etoricoxib

• Status: Terminated
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is 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 and thus reduces pain and suffering.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Erlangen-Nürnberg Medical School
• Collaborators: HELIOS Kliniken GmbH; Merck Sharp & Dohme Corp.; Rush University Medical Center
• Treatments: Etoricoxib

Criteria

Inclusion Criteria:

• Subject undergoing elective primary single hip arthroplasty

• Subject diagnosed with Osteoarthritis / arthrosis

• Subject has not taken non-steroidal anti-inflammatory drugs within 4 of their terminal half life times prior to enrollment

• Subject capable of understanding and cooperating with the requirements of the study

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 >140 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