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

Novartis

Status and phase: Completed; Phase 3

Conditions: Sore Throat Due to a Common Cold

Treatments: Drug: Lidocaine 1mg + CPC 2mg; Drug: Lidocaine 8mg + CPC 2mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01265446

2010-021653-39 (EudraCT Number)

075-A-301

Details and patient eligibility

About

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.

Enrollment: 250 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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250 participants in 2 patient groups

Lidocaine 8mg +CPC 2mg

Experimental group

Description:

one single dose

Treatment:

Drug: Lidocaine 8mg + CPC 2mg

Lidocaine 1mg + CPC 2mg

Active Comparator group

Description:

one single dose

Treatment:

Drug: Lidocaine 1mg + CPC 2mg