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

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00554346
First received: November 4, 2007
Last updated: June 20, 2010
Last verified: June 2010
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Pain at rest at different timepoint after surgical procedures [ Time Frame: From baseline(preoperation) to 3 days after ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 64
Study Start Date: May 2008
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   16 Years to 35 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
No publications provided

Responsible Party: Ching-chuan Jiang, National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00554346     History of Changes
Other Study ID Numbers: 200709062M
Study First Received: November 4, 2007
Last Updated: June 20, 2010
Health Authority: Taiwan: Department of Health

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

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

ClinicalTrials.gov processed this record on October 20, 2014