COX-2 Inhibitor Versus Glucocorticoid Versus Both Combined

NCT ID: NCT01361789

Last Updated: 2011-05-27

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2009-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Rupture of Anterior Cruciate Ligament

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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

Group Type ACTIVE_COMPARATOR

parecoxib, valdecoxib, etoricoxib

Intervention Type DRUG

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

Group Type ACTIVE_COMPARATOR

Dexamethasone

Intervention Type DRUG

8 mg IV

COXIB and dexamethasone

combination of coxib AND dexamethasone

Group Type ACTIVE_COMPARATOR

parecoxib, valdecoxib, parecoxib and dexamethasone

Intervention Type DRUG

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

Intervention Type DRUG

Dexamethasone

8 mg IV

Intervention Type DRUG

parecoxib, valdecoxib, parecoxib and dexamethasone

combination of both drugs

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Arthroscopic reconstruction of the anterior crucial ligament (ACL)
* At least 18 years old
* ASA I + II

Exclusion Criteria

* Known renal impairment
* Liver failure and/-or an asthmatic condition
* Pregnancy
* Breast feeding
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asker & Baerum Hospital

OTHER

Sponsor Role lead

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

Site Status

Countries

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Norway

Other Identifiers

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2004_01927 COX

Identifier Type: -

Identifier Source: org_study_id

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