Efficacy and Safety of a Sore Throat Lozenge Containing Lidocaine and Cetylpyridinium Chloride in Patients With Sore Throat Due to a Common Cold.

Phase 3 Completed 250 enrolled Novartis

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study will compare the efficacy and safety of a single dose of a lidocaine 8 mg + cetylpyridimium chloride (CPC) 2 mg lozenge with a single dose of a lidocaine 1 mg + CPC 2 mg lozenge in the treatment of sore throat due to a common cold.

Timeline

Start: 2010-12
Primary completion: 2011-04
Completion: 2011-04

Outcome

Missed primary endpoint

paper The difference in the 2-h post-dose change in STPI was not statistically significant between the treatments. PMID 30541606 ↗

Publications

Donath F, Mallefet P, Garreffa S, Furcha R. Efficacy of 8 mg lidocaine and 2 mg cetylpyridinium chloride (CPC) fixed-combination lozenges on sore throat pain intensity compared with 1 mg lidocaine and 2 mg CPC fixed-combination lozenges in subjects with sore throat due to upper respiratory tract infection: a randomized double-blind parallel-group single-dose study. Trials. 2018 Dec 12;19(1):679. doi: 10.1186/s13063-018-3077-6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lidocaine	Other / unclassified	1 mg	Oral
Subject	Lidocaine	Other / unclassified	8 mg	Oral
Background	Cetylpyridinium	Small molecule	2 mg	Oral

Indications

No indication recorded.