Abstract | PURPOSE: METHODS: This was a multicentre, randomised, double-blind, parallel group, placebo-controlled study. In total, 190 patients were randomised 1:1:1 to a single dose of AMC/ DCBA + lidocaine, hexylresorcinol or placebo lozenge. Subjective ratings of throat soreness, difficulty swallowing, swollen throat, numbing, and sore throat relief were obtained up to 2 hours post dose. Patient and investigator global ratings and a consumer questionnaire were also collected. The primary endpoint was the change from baseline in severity of throat soreness for both lozenges versus placebo at 2 hours post dose. RESULTS: The hexylresorcinol lozenge demonstrated superiority over placebo for primary and secondary efficacy variables including those related to throat soreness, sore throat relief and difficulty swallowing; the AMC/ DCBA + lidocaine lozenge was also superior to placebo for secondary endpoints at various time points but did not reach significance for the primary efficacy variable. Both lozenges had a rapid onset of action from 1-10 minutes post dose for the AMC/ DCBA + lidocaine lozenge and 1-5 minutes post dose for the hexylresorcinol lozenge. Numbness was reported from 1 minute post dose with the AMC/ DCBA + lidocaine lozenge and was greatest at 15 minutes. Numbness was reported from 5 minutes post dose with the hexylresorcinol lozenge and was greatest at 10 minutes. Both lozenges were well tolerated. CONCLUSIONS:
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Authors | Damien McNally, Adrian Shephard, Emma Field |
Journal | Journal of pharmacy & pharmaceutical sciences : a publication of the Canadian Society for Pharmaceutical Sciences, Societe canadienne des sciences pharmaceutiques
(J Pharm Pharm Sci)
Vol. 15
Issue 2
Pg. 281-94
( 2012)
ISSN: 1482-1826 [Electronic] Canada |
PMID | 22579007
(Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Anesthetics, Local
- Anti-Infective Agents, Local
- Benzyl Alcohols
- Cresols
- Drug Combinations
- amylmetacresol
- dichlorobenzyl alcohol
- Lidocaine
- Hexylresorcinol
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Topics |
- Adolescent
- Adult
- Aged
- Anesthetics, Local
(administration & dosage)
- Anti-Infective Agents, Local
(administration & dosage)
- Benzyl Alcohols
(administration & dosage)
- Cresols
(administration & dosage)
- Double-Blind Method
- Drug Combinations
- Female
- Hexylresorcinol
(administration & dosage)
- Humans
- Lidocaine
(administration & dosage)
- Male
- Middle Aged
- Pharyngitis
(drug therapy, etiology)
- Respiratory Tract Infections
(complications, drug therapy)
- Young Adult
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