Clinical Trial: Efficacy and Safety of Etoricoxib in Acute Ankle Sprain: A Double-Blind Comparative Study Among 2 Treatments Protocols

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Efficacy and Safety of the Non-Steroidal Anti-Inflammatory Drug Etoricoxib in the Treatment of Acute Ankle Sprain in Sports: A Randomized Double-Blind Comparative Study Among 2 Treatments in the Acute

Brief Summary: The investigators will study 2 doses of etoricoxib to prove that 60 mg once daily will be non-inferior to etoricoxib 90mg daily (for 14 days) in the treatment of acute ankle sprain in sports. The investigators objective is to discuss the point that the investigators will follow the minimal dose that is effective for the treatment of this acute condition in orthopedic.

Detailed Summary:

Study Objectives Primary

  • To compare the efficacy of those 2 treatment doses in patients with acute ankle sprain in sports Secondary
  • To compare the overall safety and tolerability of etoricoxib 60 mg and 90mg in patients with acute ankle sprain in sports

Hypothesis

  • The efficacy of etoricoxib 60 mg once daily will be non-inferior to etoricoxib 90mg daily for 14 days in the treatment of acute ankle sprain in sports.
  • The 60 mg dose of etoricoxib will have similarity in reducing the pain and will be more effective in decreasing the degree of edema, with most patients experiencing remission, which allows resumption of regular sporting activities after the end of the entire treatment.
  • Both doses will be generally well tolerated and gastrointestinal intolerance will not be seen.

Background and Significance of the Selected Topic Etoricoxib is a cyclo-oxygenase (COX)-2-selective NSAID with a higher COX-1 to COX-2 selectivity ratio than the other COX-2-selective NSAIDs rofecoxib, valdecoxib or celecoxib. In patients with rheumatoid arthritis, improvements in tender and swollen joint counts and patient and investigator global assessment of disease activity were significantly greater in etoricoxib than in placebo recipients in two studies. Etoricoxib was also significantly more effective than naproxen in one of these studies. In patients with osteoarthritis of the hip or knee, etoricoxib was significantly more effective than placebo and had similar efficacy to naproxen with regards to improvements in pain and physical function scores and patient global asses
Sponsor: Núcleo de Estudos em Esportes e Ortopedia, Brazil

Current Primary Outcome:

  • Reduction of pain during active mobilization measured using a visual analogue scale VAS at day 8 [ Time Frame: 8 days ]
  • Volumetric measurement of the ankle and foot [ Time Frame: day 1 and day 8 ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Pain during motion against resistance [ Time Frame: day 15 ]
  • Functional impairment and global assessment of efficacy by either patient and investigator [ Time Frame: day 15 ]
  • Tolerability will be assessed by the frequency of adverse experiences and global assessment of efficacy by either patient and investigator [ Time Frame: day 15 ]


Original Secondary Outcome: Same as current

Information By: Núcleo de Estudos em Esportes e Ortopedia, Brazil

Dates:
Date Received: September 4, 2007
Date Started: December 2008
Date Completion: September 2009
Last Updated: October 20, 2008
Last Verified: October 2008