Status:
COMPLETED
Use of Etoricoxib Compared to Diclofenac in the Perioperative Treatment of Patients After Total Hip Arthroplasty
Lead Sponsor:
University of Regensburg
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Coxarthrosis
Arthroplasties Hip Replacement
Eligibility:
All Genders
55-85 years
Phase:
PHASE3
Brief Summary
The primary aim of this study is to test if etoricoxib decreases the perioperative blood loss compared to diclofenac. Secondary questions to be explored are: * Does etoricoxib prevent Heterotopic os...
Detailed Description
Total Hip Arthroplasty (THA) is a common surgical procedure in orthopaedic surgery which can be associated with perioperative blood loss and severe postoperative pain. Adequate pain management is very...
Eligibility Criteria
Inclusion
- Indication for THA because of primary and secondary osteoarthritis of the hip.
- male or female patients of the age of 55 - 85 years
- informed consent afer having been informed in detail about the clinical trial by the investigator
- negative pregnancy test (\<= 2 days before inclusion) for women with child bearing potential (pre menopausal, \<2 years menopausal, not surgically sterile), use of high security contraception methods as oral contraception agents or preservatives. The use of high security conception methods is also to obligatory for male patients
Exclusion
- Known hypersensitivity to one of the two investigational medical products or substaces of similar chemical structure or to any of the excipients
- Patients who have experienced bronchospasm, asthma, acute rhinitis, urticaria, or allergic-type reactions after taking acetylsalicylic acid or NSAIDs including COX-2 (cyclooxygenase-2) inhibitors
- unexplained dysfunction of haematopoiesis
- treatment with NSAIDs or coxiben in the past 5 days before start of study
- Active peptic ulceration or active gastro-intestinal (GI) bleeding
- Pregnancy and lactation
- Congestive heart failure (NYHA II-IV)
- Established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease
- clinically relevant disease of the cardiovascular system, severe hepatic dysfunction (serum albumin \<25 g/l or Child-Pugh score ≥10), severe renal dysfunction (estimated renal creatinine clearance \<30 ml/min, clinical relevant disease of the nervous system, the endocrinium or another severe systematic disease
- Systemic lupus erythematodes or mixed connective tissue disease
- Inflammatory bowel disease
- alcohol or drug abuse during the last past 3 months
- Patients with hypertension BP persistently \> 140/90mmHG) and has not been adequately controlled
- life expectancy \<6 months
- state of mind which does not enable the patient to understand the nature of the study, its importance and possible consequences
- evidence that the respective person will not cooperate with the study protocoll
- participation of the patient in another clinical trial during the past 4 weeks before inclusion
- prior participation in this clinical trial
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01229774
Start Date
February 1 2011
End Date
August 1 2014
Last Update
September 15 2014
Active Locations (1)
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1
Department of Orthopedic Surgery
Bad Abbach, Bavaria, Germany, 93077