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.

• Authors: Bernard Schachtel, Sue Aspley, Adrian Shephard, Timothy Shea, Gary Smith, Emily Schachtel
• Journal: Trials (Trials) Vol. 15 Pg. 263 (Jul 03 2014) ISSN: 1745-6215 [Electronic] England
• PMID: 24988909 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Analgesics
• Tablets
• Flurbiprofen

Topics

• Administration, Oral
• Adolescent
• Adult
• Analgesics (administration & dosage)
• Deglutition (drug effects)
• Double-Blind Method
• Drug Administration Schedule
• Female
• Flurbiprofen (administration & dosage)
• Humans
• Male
• Middle Aged
• Pain (diagnosis, drug therapy, physiopathology)
• Pain Measurement
• Pharyngitis (diagnosis, drug therapy, physiopathology)
• Severity of Illness Index
• Tablets
• Time Factors
• Treatment Outcome
• United States
• Young Adult