Utility of the sore throat pain model in a multiple-dose assessment of the acute
analgesic flurbiprofen: a randomized controlled study.
Author(s): Schachtel B(1), Aspley S, Shephard A, Shea T, Smith G, Schachtel E.
Affiliation(s): Author information:
(1)Department of Epidemiology & Public Health, Yale University School of
Medicine, 60 College Street, New Haven, CT 06520-8034, USA.
bschachtel@srcresearch.net.
Publication date & source: 2014, Trials. , 15:263
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.
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