Analgesic efficacy of a single dose of lumiracoxib compared with rofecoxib, celecoxib and placebo in the treatment of post-operative dental pain.
This randomised, double-blind, placebo-controlled, parallel-group study compared the efficacy and tolerability of lumiracoxib (a novel COX-2 selective inhibitor) with rofecoxib, celecoxib and placebo in patients with moderate-to-severe post-operative dental pain. Following third molar extraction, patients received single oral doses of lumiracoxib 400 mg, rofecoxib 50 mg, celecoxib 200 mg or placebo (n = 355). Additional patients from a similar study, assigned to lumiracoxib, rofecoxib or placebo (n = 155), were included for analysis of the primary variable, Summed Pain Intensity Difference over the first 8 h post dose (SPID-8). For SPID-8, lumiracoxib was superior to rofecoxib (p < 0.05), celecoxib (p < 0.001) and placebo (p < 0.001). Lumiracoxib demonstrated the fastest onset of analgesia and the longest time to rescue medication use. Patient global evaluation of lumiracoxib was comparable to rofecoxib and superior to celecoxib and placebo. All treatments were well tolerated. Lumiracoxib 400 mg provides rapid, effective and sustained relief of post-operative dental pain, comparable or superior to rofecoxib.
Kellstein
D
D
Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA. david.kellstein@pharma.novartis.com
Ott
D
D
Jayawardene
S
S
Fricke
J
J
D000293:Adolescent; D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use; D000068579:Celecoxib; D016861:Cyclooxygenase Inhibitors / Q000627:therapeutic use*; D004008:Diclofenac / Q000031:analogs & derivatives; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007783:Lactones / Q000627:therapeutic use; D008297:Male; D008964:Molar, Third / Q000601:surgery; D009930:Organic Chemicals / Q000627:therapeutic use*; D010149:Postoperative Pain / Q000188:drug therapy*; D011720:Pyrazoles; D013449:Sulfonamides / Q000627:therapeutic use; D013450:Sulfones; D014081:Tooth Extraction; D016896:Treatment Outcome
D000894:Anti-Inflammatory Agents, Non-Steroidal; D016861:Cyclooxygenase Inhibitors; D007783:Lactones; D009930:Organic Chemicals; D011720:Pyrazoles; D013449:Sulfonamides; D013450:Sulfones; C116926:rofecoxib; D004008:Diclofenac; D000068579:Celecoxib; C473384:lumiracoxib