Abstract
BackgroundThe sore throat pain model has been conducted by different clinical investigators to demonstrate the efficacy of acute analgesic drugs in single-dose randomized clinical trials. The model used here was designed to study the multiple-dose safety and efficacy of lozenges containing flurbiprofen at 8.75 mg.MethodsAdults (n = 198) with moderate or severe acute sore throat and findings of pharyngitis on a Tonsillo-Pharyngitis Assessment (TPA) were randomly assigned to use either flurbiprofen 8.75 mg lozenges (n = 101) or matching placebo lozenges (n = 97) under double-blind conditions. Patients sucked one lozenge every three to six hours as needed, up to five lozenges per day, and rated symptoms on 100-mm scales: the Sore Throat Pain Intensity Scale (STPIS), the Difficulty Swallowing Scale (DSS), and the Swollen Throat Scale (SwoTS).ResultsReductions in pain (lasting for three hours) and in difficulty swallowing and throat swelling (for four hours) were observed after a single dose of the flurbiprofen 8.75 mg lozenge (P <0.05 compared with placebo). After using multiple doses over 24 hours, flurbiprofen-treated patients experienced a 59% greater reduction in throat pain, 45% less difficulty swallowing, and 44% less throat swelling than placebo-treated patients (all P <0.01). There were no serious adverse events.ConclusionsUtilizing the sore throat pain model with multiple doses over 24 hours, flurbiprofen 8.75 mg lozenges were shown to be an effective, well-tolerated treatment for sore throat pain. Other pharmacologic actions (reduced difficulty swallowing and reduced throat swelling) and overall patient satisfaction from the flurbiprofen lozenges were also demonstrated in this multiple-dose implementation of the sore throat pain model.Trial registrationThis trial was registered with ClinicalTrials.gov, registration number: NCT01048866, registration date: January 13, 2010.
Highlights
The sore throat pain model has been conducted by different clinical investigators to demonstrate the efficacy of acute analgesic drugs in single-dose randomized clinical trials
The study was conducted in accordance with the International Conference on Harmonization Good Clinical Practice and the ethical principles contained within the Declaration of Helsinki (South Africa, 1996)
The study was sensitive to single-dose effects, confirming results of previous studies on a single flurbiprofen lozenge compared with placebo [7,8,9]
Summary
The sore throat pain model has been conducted by different clinical investigators to demonstrate the efficacy of acute analgesic drugs in single-dose randomized clinical trials. As for most acute pain conditions, patients with painful pharyngitis due to upper respiratory tract infection (URTI) often require repeated treatment beyond one or two doses, especially on the first day of treatment, until. Recognizing this investigational challenge in examining multiple-dose efficacy in patients with an acute, selflimited infectious disease, we employed four specific principles of research architecture in order to tighten the design of this multiple-dose trial. We asked the patients to evaluate two other prominent throat-related symptoms which they complained of, the sensation of a ‘swollen throat’, a sensory quality commonly reported by patients with sore throat, as well as ‘difficulty swallowing’, a throat function (dysphagia, distinctly different from odynophagia) [4,5,15,16,17,18]
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