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A randomized, double-blind, parallel group, single-dose study of the efficacy of lidocaine 8 mg + cetylpyridinium chloride (CPC) 2 mg fixed combination lozenges on sore throat pain intensity compared ...

Mise à jour : Il y a 4 ans
Référence : EUCTR2010-021653-39

A randomized, double-blind, parallel group, single-dose study of the efficacy of lidocaine 8 mg + cetylpyridinium chloride (CPC) 2 mg fixed combination lozenges on sore throat pain intensity compared to Mebucaine CL lozenges (containing lidocaine 1 mg and CPC 2 mg) in subjects with sore throat due to upper respiratory tract infection

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Extrait

The main purpose of this trial is to compare the efficacy and safety of a single dose of a lidocaine 8 mg + 2 mg cetylpyridinium (CPC) lozenge with a single dose of a Mebucaine CL lozenge (containing 1 mg lidocaine and 2 mg CPC) in the treatment of sore throat due to upper respiratory tract infection. Efficacy will be demonstrated as superiority vs. Mebucaine CL on the primary efficacy outcome, which is the change from baseline to 2 hours post-dose for sore throat pain intensity. Safety will be evaluated by looking at nature and incidence of adverse events. Primary objective: - To compare the efficacy of a new fixed dose combination lozenge (8 mg Lidocaine + 2 mg CPC) with that of a marketed Mebucaine CL lozenge (1 mg Lidocaine + 2 mg CPC) on sore throat pain intensity in subjects with upper respiratory tract infection. The primary endpoint based on the sore throat pain intensity scale will be the change from baseline pain intensity at 2 hours post-dose.

Critère d'inclusion

  • Sore throat due to upper respiratory tract infection,(Planned indication for approval: Local antiseptic and analgesic treatment of sore throat and minor infections of the mouth. Relief of pain as well as irritation associated with these conditions in adults and adolescents aged 12 years and above.)

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