E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10048793 |
E.1.2 | Term | Coxarthrosis |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
•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.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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
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E.5 End points |
E.5.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |