Onset of action of a lozenge containing flurbiprofen 8.75 mg: A randomized, double-blind, placebo-controlled trial with a new method for measuring onset of analgesic activity
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- 作者：Bernard Schachtel ; Sue Aspley ; Adrian Shephard ; Timothy Shea ; Gary Smith ; Kathleen Sanner ; Laurie Savino ; Jeanne Rezuke ; Emily Schachtel
- 关键词：Onset of action ; Acute pain ; Flurbiprofen ; NSAID ; Sore throat
- 刊名：Pain
- 出版年：February, 2014
- 年：2014
- 卷：155
- 期：2
- 页码：422-428
- 全文大小：478 K
文摘
A new onset-of-action model was utilized to distinguish the pharmacologic activity of flurbiprofen 8.75 mg delivered in a lozenge from the demulcent effect of the lozenge base. In a randomized, double-blind, placebo-controlled trial, patients with sore throat rated pain on a Sore Throat Pain Intensity Scale before taking one flurbiprofen or placebo lozenge and at frequent (2-minute) intervals over the first hour after treatment. Further ratings of the Sore Throat Pain Intensity Scale and other patient-reported outcomes (difficulty swallowing, swollen throat, pain relief) were obtained at varying intervals over 6 hours. Onset of pharmacologic activity was defined as the median time of first perceived pain reduction if a patient reported clinically meaningful (at least moderate) relief. The conventional method of comparing mean treatment responses at each time point was also implemented. Demulcent action was detected at the first 2-minute assessment. By the new method, 102 flurbiprofen-treated patients were identified as first perceiving pain relief at 12 minutes, compared with >120 minutes by 102 patients using placebo (P < 0.001). By the conventional method, mean percentage pain reduction for flurbiprofen 8.75 mg was first significantly differentiated from placebo at 26 minutes (P < 0.05). Efficacy of flurbiprofen lozenge was demonstrated for 3.5-4 hours on the 4 patient-reported outcomes (all P < 0.05 compared with placebo). There were no serious adverse events. This patient-centered onset-of-action model identifies the initiation of pain relief in patients who are definite drug responders, here demonstrating that a flurbiprofen 8.75-mg lozenge provides early relief of sore throat.