CoxarthrosisPhase 3NCT01229774
Use of Etoricoxib Compared to Diclofenac in the Perioperative Treatment of Patients After Total Hip Arthroplasty
A Phase 3 study testing Etoricoxib and Diclofenac in people with Coxarthrosis and Arthroplasties Hip Replacement, run by University of Regensburg at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Coxarthrosis, Arthroplasties Hip Replacement, Perioperative Blood Loss
- What is being tested?
- Etoricoxib and Diclofenac
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2011to Aug 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Etoricoxib Compared to Diclofenac in the Perioperative Treatment of Patients After Total Hip Arthroplasty, a Prospective, Double Blind, Phase III Study
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?
Read the 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 important to achieve early mobilisation in order to avoid immobility-induced complications. Non steroidal antirheumatic agents (NSAIDs) as selective Cox-2 inhibitors are commonly used in the management of postoperative pain. There exist non-selective and selective Cox-inihibitors. Non-selective NSAIDs block the systhesis of prostagandins by the two iso-enzymes of the cyclooxygenase, Cox-1 and Cox-2. For this reason the bleeding risk after operations (e.g.tonsillectomy) is increased.
In this regard, the perioperative use of Cox-2 selective NSAIDs is advantageous for pain management after tonsillectomy. This could be shown for Rifecoxib, a selective Cox-2 inihibitor. For THAs with treatment of Etoricoxib, also a selective Cox-2 inhibitor, possible complications as the increased risk of haematoma, gastrointestinal bleeding and the need of blood transfusion could possibly be reduced. Selective Cox-2 inhibitors do not interfere with the coagulation system. Study results show that other selective Cox-2 inhibitors like meloxicam reduce perioperative blood loss. Thus, besides ensuring a good perioperative pain management, selective Cox-2 inhibitors may in addition cause less blood loss than non-selective NSAIDs.This possible reduction of blood loss during pain management with Etoricoxib (Arcoxia) will be investigated the described clinical trial.
Heterotopic ossification (HO) is a complication occurring after THA which can lead to postoperative pain and reduced function. Non-selective NSAIDs are commonly used in the prophylaxis of heterotopic ossifications after THA. The exact mechanism of prevention of bone formation is unclear. Some results indicate that the development of HO follows a Cox-2 pathway. A further aim of this clinical trial is to investigate the efficacy of Etoricoxib in the prevention of heterotropic ossification.
- Being tested
- Etoricoxib, Diclofenac
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtoricoxibDrug
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
DiclofenacDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Etoricoxib | Experimental | Not described Receives: Drug: Etoricoxib |
| Diclofenac | Active comparator | Not described Receives: Drug: Diclofenac |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Three days
Secondary outcomes (4)
Heterotopic ossification
The secondary objectives are to investigate whether after hip joint endoprosthesis Etoricoxib can prevent heterotopic ossification in equal measure as Diclofenac
Measured: six months
Postoperative pain
It will be investigated if Diclofenac and Etoricoxib effectively reduce postoperative pain after hip joint endoprosthesis at rest and during movement.
Measured: nine days
Reduction of rescue medication
It will be investigated whether Etioricoxib can reduce the use of rescue-medication as compared to Diclofenac
Measured: nine days
Gastroinstestinal tolerance
It will be investigated if the gastrointestinal tolerance of Etoricoxib is superior to the one of Diclofenac
Measured: nine days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2010 (estimated)
- Study startFeb 2011
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoxarthrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Regensburg
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01229774
- Sponsor's protocol ID
- Eto-Dic-01
- Status last verified
- Sep 2010
- First submitted
- 27 Oct 2010
- Last updated
- 15 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Etoricoxib Compared to Diclofenac in the Perioperative Treatment of Patients After Total Hip Arthroplasty, a Prospective, Double Blind, Phase III Study
- ClinicalTrials.gov ID
- NCT01229774
- Acronym / sponsor ID
- Eto-Dic-01
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of RegensburgUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Feb 2011
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 28 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
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 important to achieve early mobilisation in order to avoid immobility-induced complications. Non steroidal antirheumatic agents (NSAIDs) as selective Cox-2 inhibitors are commonly used in the management of postoperative pain. There exist non-selective and selective Cox-inihibitors. Non-selective NSAIDs block the systhesis of prostagandins by the two iso-enzymes of the cyclooxygenase, Cox-1 and Cox-2. For this reason the bleeding risk after operations (e.g.tonsillectomy) is increased.
In this regard, the perioperative use of Cox-2 selective NSAIDs is advantageous for pain management after tonsillectomy. This could be shown for Rifecoxib, a selective Cox-2 inihibitor. For THAs with treatment of Etoricoxib, also a selective Cox-2 inhibitor, possible complications as the increased risk of haematoma, gastrointestinal bleeding and the need of blood transfusion could possibly be reduced. Selective Cox-2 inhibitors do not interfere with the coagulation system. Study results show that other selective Cox-2 inhibitors like meloxicam reduce perioperative blood loss. Thus, besides ensuring a good perioperative pain management, selective Cox-2 inhibitors may in addition cause less blood loss than non-selective NSAIDs.This possible reduction of blood loss during pain management with Etoricoxib (Arcoxia) will be investigated the described clinical trial.
Heterotopic ossification (HO) is a complication occurring after THA which can lead to postoperative pain and reduced function. Non-selective NSAIDs are commonly used in the prophylaxis of heterotopic ossifications after THA. The exact mechanism of prevention of bone formation is unclear. Some results indicate that the development of HO follows a Cox-2 pathway. A further aim of this clinical trial is to investigate the efficacy of Etoricoxib in the prevention of heterotropic ossification.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Etoricoxib | Experimental | Drug: Etoricoxib |
| Diclofenac | Active comparator | Drug: Diclofenac |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EtoricoxibArcoxia 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 | Drug | Etoricoxib |
| DiclofenacVoltaren 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 | Drug | Diclofenac |
Primary outcome
Perioperative blood loss after implantation of a hip joint endoprosthesis
Time frame: Three days
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.
4 secondary outcomes
Heterotopic ossification
Time frame: six months
Postoperative pain
Time frame: nine days
Reduction of rescue medication
Time frame: nine days
Gastroinstestinal tolerance
Time frame: nine days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Etoricoxib and Diclofenac in people with Coxarthrosis and Arthroplasties Hip Replacement, run by University of Regensburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative blood loss after implantation of a hip joint endoprosthesis (time frame: Three days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2014.