Efficacy of Lumiracoxib in Relieving Moderate to Severe Post-dental Surgery Pain, Compared to Both Placebo and Celecoxib
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A Randomized, Double-blind, Double-dummy, Parallel Group, Single-center Study Evaluating the Analgesic Effect of Single Doses of Lumiracoxib 400 mg, Celecoxib 400 mg and Placebo in the Treatment of Post-dental Surgery Pain
Superiority of a single dose of lumiracoxib 400 mg compared to placebo and celecoxib 400 mg based on a Summed (time weighted) Pain Intensity Difference calculated over 0-8 hours post-dose (SPID-8)
Secondary Outcome Measures :
Evaluate efficacy of a single dose of lumiracoxib 400 mg compared to placebo and to celecoxib 400 mg in relieving post dental surgery pain with respect to the following secondary efficacy variables:
Time-specific Pain intensity Difference (PID) based on the categorical scale, Pain Relief (PR) based on the categorical scale, and Pain Relief Intensity Difference (PRID) (sum of PID and PR based on categorical scales) at time-points up to 24 hours after
Time-specific PID based on VAS at time-points up to 24 hours after dosing
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Layout table for eligibility information
Ages Eligible for Study:
17 Years and older (Child, Adult, Older Adult)
Sexes Eligible for Study:
Requiring extraction of two or more partially impacted or fully bony impacted third molars. At least one of the extractions must be mandibular
Moderate to severe post-dental surgery pain intensity (as rated by the patient on the categorical pain intensity scale within five hours of surgery
Evidence or history of any cardiac and cerebral thrombotic/ ischemic diseases and/ or events
Other protocol-defined inclusion/exclusion criteria may apply