Status:
TERMINATED
Modulation of the Surgical Inflammatory Response by Etoricoxib
Lead Sponsor:
University of Erlangen-Nürnberg Medical School
Collaborating Sponsors:
HELIOS Kliniken GmbH
Rush University Medical Center
Conditions:
Pain
Osteoarthritis, Hip
Eligibility:
All Genders
55-80 years
Phase:
PHASE2
Brief 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 ...
Detailed Description
This study will be a multiple centre, double-blind, placebo-controlled, randomized, parallel group study conducted in male and female adult patients undergoing elective primary single hip arthroplasty...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00746720
Start Date
May 1 2006
End Date
December 1 2010
Last Update
December 14 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
HELIOS Klinikum Berlin
Berlin, Germany, D-13125