Compare the consistency of treatment response of celecoxib oral solution 120 mg (COS) with placebo in adults with migraine.

Post-hoc analysis of pooled data from 2 randomized, double-blind, placebo-controlled trials in which adults completed 2 double-blind randomizations and treatment periods. During the first double-blind period, subjects used COS to treat 1 migraine attack of moderate to severe pain intensity. Within 2-7 days (ie, ≥48 hours of pain and symptom freedom), eligible subjects were rerandomized into a second double-blind period and instructed to treat a single migraine attack of any headache pain intensity. This analysis included randomized subjects who treated 2 attacks with COS or treated 2 attacks with placebo. Efficacy endpoints included pain freedom, freedom from the most bothersome symptoms (MBS), and pain relief at 2 hours postdose. Consistent responders achieved treatment success in both double-blind periods with either COS or placebo. A separate regression model was fit to the data for each endpoint. Risk rates (proportions) were presented and significance evaluated using relative risk models.

Altogether, 1253 subjects were randomized in the first double-blind period, 1080 (86%) were independently rerandomized to celecoxib (n=521) or placebo (n=517) in the second double-blind period, and 771 (celecoxib n=399) or placebo (n=372) treated 2 attacks with study medication. Rates of consistent endpoint achievement at 2 hours postdose between COS and placebo across pain freedom, MBS freedom, and pain relief were, respectively, 18% vs 11%, p=0.016; 40% vs 32%, p=0.033; and 54% vs 45%, p=0.012.

Across 2 attacks, consistent response to COS was higher than consistent response to placebo for pain freedom, freedom from the MBS, and pain relief at 2 hours postdose.