Rupture of Anterior Cruciate LigamentPhase 4NCT01361789
COX-2 Inhibitor Versus Glucocorticoid Versus Both Combined
A Phase 4 study testing parecoxib, valdecoxib, etoricoxib, Dexamethasone and parecoxib, valdecoxib, parecoxib and dexamethasone in people with Rupture of Anterior Cruciate Ligament, run by Asker & Baerum Hospital at 1 site in Norway.
Trial summary
Recent studies on molar surgery have shown that a combination of a glucocorticoid and NSAID or COX-2 selective inhibitor gives better pain relief than either of the drugs used separately. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Rupture of Anterior Cruciate Ligament
- What is being tested?
- parecoxib, valdecoxib, etoricoxib, Dexamethasone and parecoxib, valdecoxib, parecoxib and dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2004to Dec 2009
- Phase
- Phase 4
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Arthroscopic reconstruction of the anterior crucial ligament (ACL)
- At least 18 years old
- ASA I + II
Who cannot join
- Known renal impairment
- Liver failure and/-or an asthmatic condition
- Pregnancy
- Breast feeding
Trial locations and contacts
1 site in 1 country.
About this study
Recent studies on molar surgery have shown that a combination of a glucocorticoid and NSAID or COX-2 selective inhibitor gives better pain relief than either of the drugs used separately. The investigators group has also shown that adding dexamethasone on top of a regimen of paracetamol, NSAID and local anesthesia resulted in 45% painfree patients at rest after ambulatory breast cancer surgery.
The goal of this study is to test the NSAID + glucocorticoid concept in ACl repair. The investigators want to evaluate whether a selective COX-2 selective inhibitor or a glucocorticoid or a combination of both drugs, as part of a multimodal analgesic regime, can provide improved pain relief and shorter hospital stay in patients undergoing outpatient ACL surgery.
- Conditions
- Rupture of Anterior Cruciate Ligament
- Being tested
- parecoxib, valdecoxib, etoricoxib, Dexamethasone, parecoxib, valdecoxib, parecoxib and dexamethasone
- Keywords
- Arthroscopic reconstruction, Anterior crucial ligament, Coxib, Dexamethasone
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
parecoxib, valdecoxib, etoricoxibDrug
40 mg parecoxib (Dynastat, Pfizer®) one hour before surgery and 40 mg valdecoxib (prodrug of parecoxib, Bextra, Pfizer®)were given 8 hour after surgery.
After retraction of parecoxib from the market:
Etoricoxib (Arcoxia, MSD) 120 mg given one hour before surgery
DexamethasoneDrug
8 mg IV
parecoxib, valdecoxib, parecoxib and dexamethasoneDrug
combination of both drugs
| Study group | Role | What they receive |
|---|---|---|
| COXIB | Active comparator | 40 mg parecoxib (Dynastat, Pfizer®) one hour before surgery and 40 mg valdecoxib (prodrug of parecoxib, Bextra, Pfizer®)were given 8 hour after surgery.
After retraction of parecoxib from the market:
Etoricoxib (Arcoxia, MSD) 120 mg given one hour before surgery Receives: Drug: parecoxib, valdecoxib, etoricoxib |
| Dexamethasone | Active comparator | dexamethasone 8 mg iv Receives: Drug: Dexamethasone |
| COXIB and dexamethasone | Active comparator | combination of coxib AND dexamethasone Receives: Drug: parecoxib, valdecoxib, parecoxib and dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative VAS score at rest 24 hours after surgery
Measured: 24 hours
Secondary outcomes (1)
Cumulated opioid consumption
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2011 (estimated)
- Study startJan 2004
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rupture of Anterior Cruciate LigamentStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asker & Baerum Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Vegard Dahl, PhD, Principal investigator, Baerum HospitalUlrich J Spreng, MD, Principal investigator, Baerum Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01361789
- Sponsor's protocol ID
- 2004_01927 COX
- Other IDs
- 2004
- Status last verified
- May 2011
- First submitted
- 26 May 2011
- Last updated
- 27 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COX-2 Inhibitor Versus Glucocorticoid Versus Both Combined
- ClinicalTrials.gov ID
- NCT01361789
- Acronym / sponsor ID
- 2004_01927 COX
- Conditions
- Rupture of Anterior Cruciate Ligament
- Keywords
- Arthroscopic reconstruction, Anterior crucial ligament, Coxib, Dexamethasone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Asker & Baerum HospitalUniversity, hospital or other
- Study start
- Jan 2004
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 27 May 2011 (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.
Recent studies on molar surgery have shown that a combination of a glucocorticoid and NSAID or COX-2 selective inhibitor gives better pain relief than either of the drugs used separately. The investigators group has also shown that adding dexamethasone on top of a regimen of paracetamol, NSAID and local anesthesia resulted in 45% painfree patients at rest after ambulatory breast cancer surgery.
The goal of this study is to test the NSAID + glucocorticoid concept in ACl repair. The investigators want to evaluate whether a selective COX-2 selective inhibitor or a glucocorticoid or a combination of both drugs, as part of a multimodal analgesic regime, can provide improved pain relief and shorter hospital stay in patients undergoing outpatient ACL surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| COXIB | Active comparator | Drug: parecoxib, valdecoxib, etoricoxib40 mg parecoxib (Dynastat, Pfizer®) one hour before surgery and 40 mg valdecoxib (prodrug of parecoxib, Bextra, Pfizer®)were given 8 hour after surgery. After retraction of parecoxib from the market: Etoricoxib (Arcoxia, MSD) 120 mg given one hour before surgery |
| Dexamethasone | Active comparator | Drug: Dexamethasonedexamethasone 8 mg iv |
| COXIB and dexamethasone | Active comparator | Drug: parecoxib, valdecoxib, parecoxib and dexamethasonecombination of coxib AND dexamethasone |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Arthroscopic reconstruction of the anterior crucial ligament (ACL)
- At least 18 years old
- ASA I + II
Key exclusion criteria (4 listed)
- Known renal impairment
- Liver failure and/-or an asthmatic condition
- Pregnancy
- Breast feeding
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 |
|---|---|---|
| parecoxib, valdecoxib, etoricoxib40 mg parecoxib (Dynastat, Pfizer®) one hour before surgery and 40 mg valdecoxib (prodrug of parecoxib, Bextra, Pfizer®)were given 8 hour after surgery. After retraction of parecoxib from the market: Etoricoxib (Arcoxia, MSD) 120 mg given one hour before surgery | Drug | COXIB |
| Dexamethasone8 mg IV | Drug | Dexamethasone |
| parecoxib, valdecoxib, parecoxib and dexamethasonecombination of both drugs | Drug | COXIB and dexamethasone |
Primary outcome
Postoperative VAS score at rest 24 hours after surgery
Time frame: 24 hours
1 secondary outcome
Cumulated opioid consumption
Time frame: 24 hours
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 27 May 2011.
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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.
Vegard Dahl, PhD principal investigator
Baerum Hospital
Ulrich J Spreng, MD principal investigator
Baerum Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing parecoxib, valdecoxib, etoricoxib, Dexamethasone and parecoxib, valdecoxib, parecoxib and dexamethasone in people with Rupture of Anterior Cruciate Ligament, run by Asker & Baerum Hospital at 1 site in Norway.
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 3 inclusion and 4 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 27 May 2011. 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 Norway. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Postoperative VAS score at rest 24 hours after surgery (time frame: 24 hours). 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 27 May 2011.