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

• Register: EUCTR
• Last refreshed on: 24 November 2014
• Main ID: EUCTR2009-015383-33-DE
• Date of registration: 14/06/2010
• Prospective Registration: Yes
• Primary sponsor: Freistaat Bayern, vertreten durch die Universität Regensburg
• Public title: Die perioperative Anwendung von Etoricoxib verglichen mit Diclofenac bei Patienten nach Implantation einer Hüftgelenkstotalendoprothese, prospektive, doppelt blinde Phase IIIb Studie - ARCOXIA
• Scientific title: Die perioperative Anwendung von Etoricoxib verglichen mit Diclofenac bei Patienten nach Implantation einer Hüftgelenkstotalendoprothese, prospektive, doppelt blinde Phase IIIb Studie - ARCOXIA
• Date of first enrolment: 30/08/2010
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-015383-33
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: Other:

Countries of recruitment

Germany

Key inclusion & exclusion 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, <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



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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

Intervention(s)

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 milligram(s)
Concentration type: equal
Concentration number: 90-
Pharmaceutical form of the placebo: Coated tablet
Route of administration of the placebo: Oral use

Trade Name: Voltaren
Product Name: Voltaren Resinat
Product Code: 17982.00.00
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Diclofenac-Colestyramin
Other descriptive name: Diclofenac-Colestyramin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75-

Primary Outcome(s)

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.

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.

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.

Secondary ID(s)

Eto-Dic-01