EUCTR2009-015383-33-DE进行中（未招募）不适用
Die perioperative Anwendung von Etoricoxib verglichen mit Diclofenac bei Patienten nach Implantation einer Hüftgelenkstotalendoprothese, prospektive, doppelt blinde Phase IIIb Studie - ARCOXIA
Freistaat Bayern, vertreten durch die Universität Regensburg0 个研究点开始时间: 2010年6月14日最近更新:
适应症
相关药物
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
- •Primary or secondary cox-arthrosis where a hip joint endoprosthesis is indicated
- •Male or female patients aged 55 =85 years
- •Written informed consent of the participating patient after detailed information by the investigator
- •Negative pregnancy test (max. 2 days before inclusion into the study). Women of child bearing potential (pre-menopausal, <2 years menopausal, not surgically sterilized) have to use accepted methods of contraception.
- •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
- •Known hypersensitivitiy to one of the two tested drugs (Etoricoxib or Diclofenac) or medical products of a similar chemical structure or another component of the tested drugs.
- •Known reactions of bronchospasm, asthma, rhinitis or urticaria after intake of acetylsalicyclic acid or of other non-steroidal antiphlogistic substances in the past
- •hematopoietic dysfunction of unknown origin
- •treatment with non-steroidal antiphlogistics, coxibes in the last five days before start of the study
- •Active peptic ulcer or active gastiontestinal bleeding
- •Heart insuffiency (NYHA II-IV)
- •Clinically relevant heart diseases, diseases of the liver (Albumin < 25g/l), the kidneys (GFR <30ml/min) the nervous system, the endocrine system or another serious systematic disease
- •Clinically assured coronary heart disease, peripheral arterial occlusive disease and / cerebro-vascular disease
- •Inflammatory gastric disease
- •Patients with uncontrolled hypertension whose blood pressure is constantly elevated (>140/90 mmHg)
- •Participation in another clinical trial during the last four weeks before study start or participation in the same study in the past
- •Life expectancy >6 months
- •Pregnancy or breast feeding
- •Systematic lupus eythematodes or mixed collagenosis
- •Indications that the potential study participant will probably not follow the study protocol because i.e. a lack of cooperation
- •Menthal ability which does not enable the patient to understand the sense of the clinical trial its range and possible consequences
- •Alcohol or drug abuse during the last three months before the start of the study
研究者
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