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

• Conditions: Sore Throat Due to a Common Cold
• Interventions: Drug: Lidocaine 1mg + CPC 2mg; Drug: Lidocaine 8mg + CPC 2mg

• Registration Number: NCT01265446
• Lead Sponsor: Novartis

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2010-12-20
• Study First Submitted QC: 2010-12-22
• Study First Posted: 2010-12-23
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Results First Submitted: 2012-03-29
• Results First Submitted QC: 2012-06-19
• Results First Posted: 2012-07-26
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-17
• Last Update Posted: 2013-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lidocaine 1mg + CPC 2mg	Lidocaine 1mg + CPC 2mg	one single dose
Lidocaine 8mg +CPC 2mg	Lidocaine 8mg + CPC 2mg	one single dose

Primary Outcome Measures

Name	Time	Method
Change From Baseline Sore Throat Pain Intensity	Baseline and 2 hours post-dose	100 milimeter (mm) visual acuity score (left=no pain=0mm, right=worst possible pain=100mm)

Secondary Outcome Measures

Name	Time	Method
Change From Baseline Sore Throat Pain Intensity up to 240 mn Post-dose	Baseline and 240 mn post-dose	100 milimeter (mm) visual acuity score (left=no pain=0mm, right=worst possible pain=100mm). It measures the highest pain level felt by the patient.

Trial Locations

Locations (1)

Socratec; 🇩🇪 Erfurt, Germany