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

Sore Throat Due to a Common Cold Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01265446
• Other study ID #: 075-A-301
• Secondary ID: 2010-021653-39
• Status: Completed
• Phase: Phase 3
• First received: December 20, 2010
• Last updated: April 17, 2013
• Start date: December 2010
• Est. completion date: April 2011

Study information

• Verified date: April 2013
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Common Cold
• Pharyngitis
• Respiratory Tract Infections
• Sore Throat Due to a Common Cold

Intervention

Drug:
• Lidocaine 8mg + CPC 2mg
one single dose
• Lidocaine 1mg + CPC 2mg
one single dose

Locations

Country	Name	City	State
Germany	Socratec	Erfurt

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline Sore Throat Pain Intensity	100 milimeter (mm) visual acuity score (left=no pain=0mm, right=worst possible pain=100mm)	Baseline and 2 hours post-dose	No
Secondary	Change From Baseline Sore Throat Pain Intensity up to 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.	Baseline and 240 mn post-dose	No