Bernard Schachtel1,2, Adrian Shephard3, Emily Schachtel1, Mary Beth Lorton1, Tim Shea4, Sue Aspley3. 1. Schachtel Research Company Inc., Jupiter, FL 33477, USA. 2. Yale School of Public Health, New Haven, CT 06520-8034, USA. 3. Reckitt Benckiser Healthcare International Ltd, 103-105 Bath Road, Slough, Berkshire SL1 3UH, UK. 4. Reckitt Benckiser, Parsippany, NJ 07054-0225, USA.
Abstract
AIM: Patients with pharyngitis often describe various sensory, affective and evaluative pain qualities. Using an 11-word/phrase index, the Qualities of Sore Throat Index (QuaSTI), we characterized throat symptoms and evaluated changes in a randomized controlled trial (NCT01986361). MATERIALS & METHODS: Patients received a single flurbiprofen 8.75 mg (n = 101) or placebo (n = 21) lozenge and rated throat soreness at baseline and regular intervals over 3 h, and the QuaSTI at baseline, 1, 2 and 3 h post-treatment. RESULTS: The QuaSTI distinguished active drug from placebo and detected clinically important (≥2-point) changes over 3 h. Mean change from baseline over 3 h was significantly greater for flurbiprofen (154%) than placebo (p < 0.05). CONCLUSION: The QuaSTI is a sensitive instrument for measuring therapeutic effects in patients with pharyngitis.
RCT Entities:
AIM: Patients with pharyngitis often describe various sensory, affective and evaluative pain qualities. Using an 11-word/phrase index, the Qualities of Sore Throat Index (QuaSTI), we characterized throat symptoms and evaluated changes in a randomized controlled trial (NCT01986361). MATERIALS & METHODS:Patients received a single flurbiprofen 8.75 mg (n = 101) or placebo (n = 21) lozenge and rated throat soreness at baseline and regular intervals over 3 h, and the QuaSTI at baseline, 1, 2 and 3 h post-treatment. RESULTS: The QuaSTI distinguished active drug from placebo and detected clinically important (≥2-point) changes over 3 h. Mean change from baseline over 3 h was significantly greater for flurbiprofen (154%) than placebo (p < 0.05). CONCLUSION: The QuaSTI is a sensitive instrument for measuring therapeutic effects in patients with pharyngitis.
Authors: Rob Turner; Sean Robert Wevrett; Suzanne Edmunds; Marc B Brown; Robert Atkinson; Oluwajoba Adegoke; Anuradha Kulasekaran; Tim Shea Journal: Clin Pharmacol Date: 2020-03-24
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Authors: Rob Turner; Sean Robert Wevrett; Suzanne Edmunds; Marc Brown; Robert Atkinson; Tim Shea Journal: Biomed Chromatogr Date: 2019-05-06 Impact factor: 1.902