COX-2 Inhibitor Versus Glucocorticoid Versus Both Combined
NCT ID: NCT01361789
Last Updated: 2011-05-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
93 participants
INTERVENTIONAL
2004-01-31
2009-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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COXIB
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
parecoxib, valdecoxib, etoricoxib
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
Dexamethasone
dexamethasone 8 mg iv
Dexamethasone
8 mg IV
COXIB and dexamethasone
combination of coxib AND dexamethasone
parecoxib, valdecoxib, parecoxib and dexamethasone
combination of both drugs
Interventions
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parecoxib, valdecoxib, etoricoxib
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
Dexamethasone
8 mg IV
parecoxib, valdecoxib, parecoxib and dexamethasone
combination of both drugs
Eligibility Criteria
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Inclusion Criteria
* At least 18 years old
* ASA I + II
Exclusion Criteria
* Liver failure and/-or an asthmatic condition
* Pregnancy
* Breast feeding
18 Years
90 Years
ALL
No
Sponsors
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Asker & Baerum Hospital
OTHER
Responsible Party
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Vestre Viken HF
Principal Investigators
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Vegard Dahl, PhD
Role: PRINCIPAL_INVESTIGATOR
Baerum Hospital
Ulrich J Spreng, MD
Role: PRINCIPAL_INVESTIGATOR
Baerum Hospital
Locations
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Baerum Hospital
Rud, , Norway
Countries
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Other Identifiers
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2004_01927 COX
Identifier Type: -
Identifier Source: org_study_id
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