Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:28 AM
Ignite Modification Date:
2025-12-25 @ 4:28 AM
NCT ID:
NCT00746720
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
55 Years
Maximum Age:
80 Years
Study:
NCT00746720
Study Brief:
Protocol Section:
NCT00746720