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: 12.1 Level: LLT Classification code 10048793 Term: Coxarthrosis
Conditions
Interventions
Trade Name: ARCOXIA
Product Name: ARCOXIA
Product Code: INR 10018/09-2008
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Etoricoxib
Other descriptive name: Etoricoxib
Concentration unit: mg m
Sponsors
Freistaat Bayern, vertreten durch die Universität Regensburg
Eligibility
Sex/Gender
All
Inclusion criteria
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, =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: It will be analyzed whether the use of Etoricoxib as compared to Diclofenac leads to a reduction of the perioperative risk of bleedings. The primary objective of the study is the designation of the perioperative blood loss after implantation of a hip joint endoprosthesis under the influence of Etoricoxib or of Diclofenac. The expectations hypothesis is that under Etoricoxib patients will loose a smaller quantity of blood than under Diclofenac.;Secondary Objective: •The secondary objectives are to investigate whether after hip joint endoprosthesis Etoricoxib can prevent heterotrophic ossification in equal measure as Diclofenac. •It will be investigated if Diclofenac and Etoricoxib effectively reduce postoperative pain after hip joint endoprosthesis at rest and during movement. •It will be investigated whether Etioricoxib can reduce the use of rescue-medication as compared to Diclofenac •It will be investigated if the gastrointestinal tolerance of Etoricoxib is superior to the one of Diclofenac. ;Primary end point(s): The primary endpoint of the study is the designation of the total perioperative blood loss after implantation of a hip joint endoprosthesis under the influence of Etoricoxib or of Diclofenac. | — |
Countries
Germany
Outcome results
None listed