A Randomized, Double Blind, Placebo-controlled Study to Assess the the Preemptive Benefit of Etoricoxib in Patients Receiving Anterior Cruciate Ligament Reconstruction

National Taiwan University

Status and phase: Completed; Phase 4

Conditions: Post-operational Pain

Treatments: Drug: Arcoxia(etoricoxib 90 mg/tablet)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00554346

200709062M

Details and patient eligibility

About

Post surgical pain associated with ligament reconstruction may persist for few days after the surgical procedure. Arcoxia is a new anti-inflammatory and analgesic drug that alleviate pain through oral administration. This study will test the safety and efficacy of Arcoxia in the management of post-operational pain in patients receive the ligament reconstruction surgery.

Enrollment: 64 estimated patients

Sex: All

Ages: 16 to 35 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

1. Men and women age ranged from 16~35 who have anterior cruciate ligament injury and/or associated injuries are scheduled for ACL reconstruction surgery.
2. Patient agrees to participate into this study and is willing to sign the patient informed consent form.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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64 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

Etoricoxib 90mg

Treatment:

Drug: Arcoxia(etoricoxib 90 mg/tablet)

2

Placebo Comparator group

Description:

placebo

Treatment:

Drug: Arcoxia(etoricoxib 90 mg/tablet)