EUCTR2005-003854-80-DE进行中（未招募）不适用
Modulation of the Surgical Inflammatory Response by Etoricoxib: Peripheral versus Central
Department of Experimental and Clinical Pharmacology and Toxicology, Friedrich-Alexander-University0 个研究点开始时间: 2006年1月4日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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