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

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 Lozenges Containing Lidocaine 1 mg and CPC 2 mg in Subjects With Sore Throat Due to Upper Respiratory Tract Infection.

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.

Inclusion Criteria:

• Patients with sore throat due to an upper respiratory tract infection, with recent onset (within 48 hours)
• Sore throat of at least moderate pain intensity

Exclusion Criteria:

• - History of hypersensitivity to any of the study drugs and listed excipients or to drugs of similar chemical classes
• Evidence of mouth breathing or severe coughing
• Evidence of overt oropharyngeal bacterial or fungal infection or evidence of lower respirator tract infection
• Severe renal, liver or cardiac impairment
• Severe lung disease