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

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.

Efficacy of flurbiprofen 8.75 mg spray in patients with sore throat due to an upper respiratory tract infection: A randomised controlled trial

“…The study was conducted on an established drug formulation, over a short period, and the study design was robust and used well-validated methodologies. [23,24,26,27] Patients in both groups took a similar number of doses over three days, enabling a fairer comparison between treatments. However, patients were recruited from different sources (general practice, community pharmacy or advertisements) and may have had a diverse range of symptoms although this would more accurately represent the patient population.…”

“…five points on the Tonsillo-Pharyngitis Assessment (TPA), an index of seven physician-assessed objective features of pharyngitis. [23,24] Patients were ineligible if they had any evidence of mouth breathing, severe coughing, any allergy and/or intolerance to the study drug, formulation ingredients or hypersensitivity to paracetamol. Standard warnings and contraindications for NSAIDs were used to assess patient eligibility.…”

“…The methods used were based on the validated Sore Throat Pain Model, which has been used for studies of flurbiprofen 8.75 mg lozenge. [23,24,26,27] …”

“…[3,21] Previous studies have demonstrated the efficacy of flurbiprofen lozenge and granule formulations (8.75 mg per dose) for symptomatic relief of sore throat. [22][23][24] Recently, an innovative spray formulation containing 8.75 mg of flurbiprofen per dose has been developed for sore throat symptom relief. The spray formulation offers advantages such as rapid delivery to the affected area and is convenient to use.…”

Efficacy and safety of a triple active sore throat lozenge in the treatment of patients with acute pharyngitis: Results of a multi-centre, randomised, placebo-controlled, double-blind, parallel-group trial (DoriPha)

“…: In reviewing placebo‐controlled efficacy trials of lozenges in patients with acute pharyngitis based on a PubMed literature search for “lozenge AND pharyngitis AND randomized controlled trial” (Table 5), we conclude non‐steroidal anti‐inflammatory drugs (NSAIDs) and topical analgesics can provide short‐term pain relief within 1‐2 hours in comparison with placebo. However, these trials frequently did not address complete remission or failed in detecting superiority over placebo over the course of 3‐4 days ‐ often explained by the natural improvement in the disease in a few days 23, 24, 25…”