title: 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.
  
  
  BACKGROUND
  This trial was registered with ClinicalTrials.gov, registration number: NCT01048866, registration date: January 13, 2010.
authors.affiliation: Department of Epidemiology & Public Health, Yale University School of Medicine, 60 College Street, New Haven, CT 06520-8034, USA. bschachtel@srcresearch.net.
authors.forename: Bernard
authors.initials: B
authors.lastname: Schachtel
authors.forename: Sue
authors.initials: S
authors.lastname: Aspley
authors.forename: Adrian
authors.initials: A
authors.lastname: Shephard
authors.forename: Timothy
authors.initials: T
authors.lastname: Shea
authors.forename: Gary
authors.initials: G
authors.lastname: Smith
authors.forename: Emily
authors.initials: E
authors.lastname: Schachtel
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000700:Analgesics / Q000008:administration & dosage*; D003679:Deglutition / Q000187:drug effects; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005480:Flurbiprofen / Q000008:administration & dosage*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D010147:Pain Measurement; D010612:Pharyngitis / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D012720:Severity of Illness Index; D013607:Tablets; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States; D055815:Young Adult
chemical_list: D000700:Analgesics; D013607:Tablets; D005480:Flurbiprofen