Utility of the sore throat pain model in a multiple-dose assessment of the acute analgesic flurbiprofen: a randomized controlled study

Abstract

Background: 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 model used here was designed to study the multiple-dose safety and efficacy of lozenges containing flurbiprofen at 8.75 mg.

Methods: Adults (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).

Results: Reductions 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.

Conclusions: Utilizing 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 registration: This trial was registered with ClinicalTrials.gov, registration number: NCT01048866, registration date: January 13, 2010.

Figures

Figure 1

Visual analog scales to assess patient-reported outcomes. The 100-mm visual analog scales used were A) the Sore Throat Pain Intensity Scale (STPIS) to assess sore throat pain, B) the Difficulty Swallowing Scale (DSS) to assess difficulty swallowing, and C) the Swollen Throat Scale (SwoTS) to assess the sensation of a swollen throat.

Figure 2

Patient disposition. *Discontinuation was due to headache.

Figure 3

Efficacy of multiple doses of flurbiprofen 8.75 mg or placebo lozenges over 24 hours. ANOVA was used to compare flurbiprofen 8.75 mg and placebo groups for the time-weighted summed differences in LS mean scores over 24 hours for A) sore throat pain (on the STPIS), B) difficulty swallowing (on the DSS), and C) swollen throat (on the SwoTS). ANOVA, analysis of variance; CI, confidence interval; DSS, Difficulty Swallowing Scale; h, hour; LS, least square; STPIS, Sore Throat Pain Intensity Scale; SwoTS, Swollen Throat Scale.

Figure 4

Efficacy of a single flurbiprofen 8.75 mg or placebo lozenge over six hours. ANOVA was used to compare flurbiprofen 8.75 mg (n = 101) and placebo (n = 97 up to two hours, n = 96 from three to six hours, as one patient withdrew from the study) for the effects of a single dose on absolute mean change over six hours in A) sore throat pain (on the STPIS), B) difficulty swallowing (on the DSS), and C) swollen throat (on the SwoTS). Error bars represent the 95% CIs. *P <0.05, **P <0.01, ***P <0.001 compared with placebo. ANOVA, analysis of variance; CI, confidence interval; DSS, Difficulty Swallowing Scale; LS, Least square; STPIS, Sore Throat Pain Intensity Scale; SwoTS, Swollen Throat Scale.

Figure 5

Cumulative percentage of patients achieving at least a 20% reduction from baseline in Sore Throat Pain Intensity Scale (STPIS) score.