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Noninferiority of parecoxib to ketoprofen was declared if the lower bound of the 95% conidence interval (CI) for the difference between the two groups excluded the pre-established margin of 10 mm for the primary endpoint. |
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2楼2013-01-15 14:03:19
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Materials and Methods: Phase i.v., multicenter, double-blind, noninferiority, active-controlled study: 338 subjects with acute renal colic were randomized to parecoxib 40 mg i.v. plus placebo (n = 174) or ketoprofen 100 mg i.v. plus placebo (n = 164). 338 subjects with acute renal colic were randomized to parecoxib 40 mg i.v. (n = 174) or ketoprofen 100 mg i.v. (n = 164) plus placebo. Subjects were evaluated 15, 30, 45, 60, 90 and 120 minutes after treatment start and 24 hours after discharge. Primary endpoint was the mean pain intensity difference (PID) at 30 minutes by visual analog scale (VAS) (per-protocol population). An ANCOVA model was used with treatment group, country, and baseline score as covariates. Noninferiority of parecoxib to ketoprofen was declared if the lower bound of the 95% conidence interval (CI) for the difference between the two groups excluded the pre-established margin of 10 mm for the primary endpoint. |
3楼2013-01-15 14:09:24
4楼2013-01-15 15:14:27
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