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Efficacy and safety of celecoxib in the treatment of acute pain due to ankle sprain in a Latin American and Middle Eastern population.

Abstract
Ankle sprains are common acute soft-tissue injuries. This 7-day open-label, multicentre, randomized study compared the efficacy and safety of celecoxib with non-selective non-steroidal anti-inflammatory drugs (NSAIDs) in treating acute ankle sprain with moderate-to-severe ankle pain in 278 patients. Patients received either celecoxib (400 mg loading dose followed by 200 mg twice daily) or standard doses of non-selective NSAIDs. The primary endpoint was a change in the patient's assessment of ankle pain on a 0 mm (no pain) - 100 mm (worst possible pain) visual analogue scale (VAS) at day 3 compared with baseline. From a baseline of 73 mm, mean VAS pain scores decreased to 29 and 32 mm in the celecoxib and non-selective NSAID groups, respectively. The lower limit of the 95% confidence interval for the treatment difference with regard to change from baseline was greater than the pre-established non-inferiority margin of -10 mm. Using an initial loading dose, celecoxib was at least as efficacious as non-selective NSAIDs in treating acute pain due to ankle sprain.
AuthorsE Cardenas-Estrada, L G Oliveira, H L Abad, F Elayan, N Khalifa, T El-Usseini
JournalThe Journal of international medical research (J Int Med Res) 2009 Nov-Dec Vol. 37 Issue 6 Pg. 1937-51 ISSN: 0300-0605 [Print] England
PMID20146894 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Anti-Inflammatory Agents, Non-Steroidal
  • Cyclooxygenase 2 Inhibitors
  • Pyrazoles
  • Sulfonamides
  • Celecoxib
Topics
  • Acute Disease
  • Ankle Injuries (complications)
  • Anti-Inflammatory Agents, Non-Steroidal (administration & dosage, adverse effects, therapeutic use)
  • Celecoxib
  • Cyclooxygenase 2 Inhibitors (administration & dosage, adverse effects, therapeutic use)
  • Demography
  • Dose-Response Relationship, Drug
  • Endpoint Determination
  • Humans
  • Latin America
  • Middle East
  • Outcome Assessment, Health Care
  • Pain (drug therapy, etiology)
  • Pyrazoles (administration & dosage, adverse effects, therapeutic use)
  • Sprains and Strains (complications)
  • Sulfonamides (administration & dosage, adverse effects, therapeutic use)
  • Treatment Outcome

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