Use of Etoricoxib Compared to Diclofenac in the Perioperative Treatment of Patients After Total Hip Arthroplasty

NCT01229774 | Completed Phase 3

• 1 other identifier: Eto-Dic-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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 ossification after Total Hip Arthroplasty as well as diclofenac ?
• Do diclofenac and etoricoxib both reduce pain at rest and on movements?
• Does etoricoxib compared to diclofenac reduce the amount of rescue medication (Oxycodon)?
• Does etoricoxib improve gastrointestinal tolerability compared to diclofenac?

Conditions

Coxarthrosis; Arthroplasties Hip Replacement; Perioperative Blood Loss

Outcome Measures

Primary Outcomes (1)

• Perioperative blood loss after implantation of a hip joint endoprosthesis

  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.

  Three days

Secondary Outcomes (4)

• Heterotopic ossification

  six months

• Postoperative pain

  nine days

• Reduction of rescue medication

  nine days

• Gastroinstestinal tolerance

  nine days

Study Arms (2)

Etoricoxib

EXPERIMENTAL

Drug: Etoricoxib

Diclofenac

ACTIVE COMPARATOR

Drug: Diclofenac

Interventions

Etoricoxib DRUG

Arcoxia 90 mg once a day in the evening day -1 and 0 and once a day in the morning days 1-7 plus on tablett of placebo every evening

Etoricoxib

Diclofenac DRUG

Voltaren Resinat 75mg once a day on day -1 and 0 in the evening; twice a day (in the morning and in the evening) days 1-7

Diclofenac

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Regensburg: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Department of Orthopedic Surgery

Bad Abbach, Bavaria, 93077, Germany

Location

MeSH Terms

Conditions

Osteoarthritis, Hip

Interventions

Etoricoxib; Diclofenac

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Sulfones; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 27, 2010
• First Posted: October 28, 2010
• Study Start: February 1, 2011
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: September 15, 2014

Record last verified: 2010-09

Locations

DE (1)