Efficacy of celecoxib, a COX-2-specific inhibitor, and naproxen in the management of acute ankle sprain: results of a double-blind, randomized controlled trial.
OBJECTIVE
To assess the efficacy and safety of celecoxib and naproxen in the treatment of acute ankle sprain.


METHODS
Double-blind, parallel-group, randomized trial.


METHODS
Multicenter outpatient.


METHODS
Adult patients (n = 397) with acute first-degree or second-degree ankle sprain.


METHODS
Patients randomized to celecoxib 200 mg b.i.d. (n = 198) or naproxen 500 mg b.i.d. (n = 198) for 7 days.


METHODS
Primary measures of efficacy were Patient's Assessment of Ankle Pain Visual Analogue Scale (VAS) and Patient's Global Assessment of Ankle Injury. Secondary efficacy measures included Physician's Global Assessment of Ankle Injury, Patient's Return to Normal Function/Activity, and Patients' and Physicians' Satisfaction Assessments. Adverse events (AEs) were reported by investigators during the study.


RESULTS
For the primary endpoints at day 4, the mean pain VAS scores were 31.9 mm +/- 1.96 for celecoxib and 29.0 mm +/- 1.91 for naproxen, and the responder rate for Patient's Global Assessment of Ankle Injury was 71% in the celecoxib group and 72% in the naproxen group, differences that were not statistically significant. In addition, noninferiority analysis demonstrated treatment differences that were within prespecified minimal clinical important differences. Gastrointestinal AEs were the most common AE, accounting for 14% in the celecoxib group and 21% in the naproxen group. The incidence of dyspepsia was 3% for celecoxib compared with 12% for naproxen (P = 0.032).


CONCLUSIONS
Celecoxib is as effective as naproxen in treating acute first-degree or second-degree ankle sprains but causes significantly less dyspepsia.
Petrella
Robert
R
Canadian Center for Activity and Aging, London, Ontario, Canada. petrella@julian.uwo.ca
Ekman
Evan F
EF
Schuller
Reinhard
R
Fort
John G
JG
D000208:Acute Disease; D000328:Adult; D016512:Ankle Injuries / Q000188:drug therapy*; D000068579:Celecoxib; D016861:Cyclooxygenase Inhibitors / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D009288:Naproxen / Q000627:therapeutic use*; D010147:Pain Measurement; D011720:Pyrazoles; D020127:Recovery of Function; D013180:Sprains and Strains / Q000188:drug therapy*; D013449:Sulfonamides / Q000627:therapeutic use*; D016896:Treatment Outcome
D016861:Cyclooxygenase Inhibitors; D011720:Pyrazoles; D013449:Sulfonamides; D009288:Naproxen; D000068579:Celecoxib