Phase 3
N=250
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
Bottom Line
View on ClinicalTrials.gov: NCT01265446 ↗Enrolled (actual)
250
Serious AEs
0.4%
Results posted
Jul 2012
Primary outcome: Primary: Change From Baseline Sore Throat Pain Intensity — -27.4; -26.9 mm
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Lidocaine 8mg + CPC 2mg (Drug); Lidocaine 1mg + CPC 2mg (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis
- Primary completion
- Apr 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline Sore Throat Pain Intensity |
-27.4; -26.9 | — |
| SECONDARY Change From Baseline Sore Throat Pain Intensity up to 240 mn Post-dose |
-25.5; -29.1 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01265446). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.