Overview

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