Back to resultsEfficacy and Safety of a Sore Throat Lozenge Containing Lidocaine and Cetylpyridinium Chloride in Patients With Sore Throat Due to a Common Cold.
Primary Purpose
Sore Throat Due to a Common Cold
Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Lidocaine 8mg + CPC 2mg
Lidocaine 1mg + CPC 2mg
Sponsored by
About this trial
This is an interventional treatment trial for Sore Throat Due to a Common Cold focused on measuring Sore throat, upper respiratory tract infection, lozenge with lidocaine and cetylpyridinium chloride.
Eligibility Criteria
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
Sites / Locations
- Socratec
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Lidocaine 8mg +CPC 2mg
Lidocaine 1mg + CPC 2mg
Arm Description
one single dose
one single dose
Outcomes
Primary Outcome Measures
Change From Baseline Sore Throat Pain Intensity
100 milimeter (mm) visual acuity score (left=no pain=0mm, right=worst possible pain=100mm)
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01265446
Brief Title
Efficacy and Safety of a Sore Throat Lozenge Containing Lidocaine and Cetylpyridinium Chloride in Patients With Sore Throat Due to a Common Cold.
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.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sore Throat Due to a Common Cold
Keywords
Sore throat, upper respiratory tract infection, lozenge with lidocaine and cetylpyridinium chloride.
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
250 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lidocaine 8mg +CPC 2mg
Arm Type
Experimental
Arm Description
one single dose
Arm Title
Lidocaine 1mg + CPC 2mg
Arm Type
Active Comparator
Arm Description
one single dose
Intervention Type
Drug
Intervention Name(s)
Lidocaine 8mg + CPC 2mg
Intervention Description
one single dose
Intervention Type
Drug
Intervention Name(s)
Lidocaine 1mg + CPC 2mg
Intervention Description
one single dose
Primary Outcome Measure Information:
Title
Change From Baseline Sore Throat Pain Intensity
Description
100 milimeter (mm) visual acuity score (left=no pain=0mm, right=worst possible pain=100mm)
Time Frame
Baseline and 2 hours post-dose
Secondary Outcome Measure Information:
Title
Change From Baseline Sore Throat Pain Intensity up to 240 mn Post-dose
Description
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.
Time Frame
Baseline and 240 mn post-dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Investigator
Organizational Affiliation
SocraTec R&D GmbH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Socratec
City
Erfurt
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
30541606
Citation
Donath F, Mallefet P, Garreffa S, Furcha R. Efficacy of 8 mg lidocaine and 2 mg cetylpyridinium chloride (CPC) fixed-combination lozenges on sore throat pain intensity compared with 1 mg lidocaine and 2 mg CPC fixed-combination lozenges in subjects with sore throat due to upper respiratory tract infection: a randomized double-blind parallel-group single-dose study. Trials. 2018 Dec 12;19(1):679. doi: 10.1186/s13063-018-3077-6.
Results Reference
derived
Learn more about this trial
Efficacy and Safety of a Sore Throat Lozenge Containing Lidocaine and Cetylpyridinium Chloride in Patients With Sore Throat Due to a Common Cold.
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