Die perioperative Anwendung von Etoricoxib verglichen mit Diclofenac bei Patienten nach Implantation einer Hüftgelenkstotalendoprothese, prospektive, doppelt blinde Phase IIIb Studie - ARCOXIA

• Conditions: In this clinical trial we will investigate patients who suffer from primary or secondary coxarthrosis where an implantation of a total hip joint endoprosthesis is indicated. It will be analyzed whether the use of Etoricoxib as compared to Diclofenac leads to a reduction of the perioperative risk of bleedings.; MedDRA version: 12.1Level: LLTClassification code 10048793Term: Coxarthrosis

• Registration Number: EUCTR2009-015383-33-DE
• Lead Sponsor: Freistaat Bayern, vertreten durch die Universität Regensburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06-14
• Last Update Posted: 24 November 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

•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

Exclusion Criteria

•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified