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

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ClinicalTrials.gov Identifier: NCT00554346
Recruitment Status : Completed
First Posted : November 6, 2007
Last Update Posted : June 22, 2010
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
National Taiwan University Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Post-operational Pain Drug: Arcoxia(etoricoxib 90 mg/tablet) Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double Blind, Placebo-controlled Study to Assess the the Preemptive Benefit of Etoricoxib in Patients Receiving Anterior Cruciate Ligament Reconstruction
Study Start Date : May 2008
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
Etoricoxib 90mg
Drug: Arcoxia(etoricoxib 90 mg/tablet)
Arcoxia(etoricoxib 90 mg/tablet) or placebo, #1, 3 days
Placebo Comparator: 2
placebo
Drug: Arcoxia(etoricoxib 90 mg/tablet)
Arcoxia(etoricoxib 90 mg/tablet) or placebo, #1, 3 days



Primary Outcome Measures :
  1. Pain at rest at different timepoint after surgical procedures [ Time Frame: From baseline(preoperation) to 3 days after ]


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00554346


Locations
Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Sponsors and Collaborators
National Taiwan University Hospital
Merck Sharp & Dohme Corp.
Investigators
Study Chair: Ching Chuan Jiang, Professor National Taiwan University Hospital

Responsible Party: Ching-chuan Jiang, National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00554346     History of Changes
Other Study ID Numbers: 200709062M
First Posted: November 6, 2007    Key Record Dates
Last Update Posted: June 22, 2010
Last Verified: June 2010

Keywords provided by National Taiwan University Hospital:
COX-2; post-operative ; sports injury; surgical pain

Additional relevant MeSH terms:
Etoricoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents