Sore Throat Due to a Common Cold
Conditions
Keywords
Sore throat, upper respiratory tract infection, lozenge with lidocaine and cetylpyridinium chloride.
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.
Interventions
DRUGLidocaine 8mg + CPC 2mg
one single dose
DRUGLidocaine 1mg + CPC 2mg
one single dose
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Germany
Participant flow
Recruitment details
14 Dec 2010 to 5 Apr 2011
Participants by arm
| Arm | Count |
|---|---|
| Lidocaine 8mg +CPC 2mg one single dose | 125 |
| Lidocaine 1mg + CPC 2mg one single dose | 125 |
| Total | 250 |
Baseline characteristics
| Characteristic | Lidocaine 1mg + CPC 2mg | Lidocaine 8mg +CPC 2mg | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 125 Participants | 125 Participants | 250 Participants |
| Age Continuous | 31.6 years STANDARD_DEVIATION 11.6 | 32.1 years STANDARD_DEVIATION 12.6 | 31.9 years STANDARD_DEVIATION 12.1 |
| Region of Enrollment Germany | 125 participants | 125 participants | 250 participants |
| Sex: Female, Male Female | 67 Participants | 67 Participants | 134 Participants |
| Sex: Female, Male Male | 58 Participants | 58 Participants | 116 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 10 / 125 | 9 / 125 |
| serious Total, serious adverse events | 1 / 125 | 0 / 125 |
Outcome results
Primary
Change From Baseline Sore Throat Pain Intensity
100 milimeter (mm) visual acuity score (left=no pain=0mm, right=worst possible pain=100mm)
Time frame: Baseline and 2 hours post-dose
Population: Intent to treat
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Lidocaine 8mg +CPC 2mg | Change From Baseline Sore Throat Pain Intensity | -27.4 mm |
| Lidocaine 1mg + CPC 2mg | Change From Baseline Sore Throat Pain Intensity | -26.9 mm |
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.
Time frame: Baseline and 240 mn post-dose
Population: intent to treat
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Lidocaine 8mg +CPC 2mg | Change From Baseline Sore Throat Pain Intensity up to 240 mn Post-dose | -25.5 mm |
| Lidocaine 1mg + CPC 2mg | Change From Baseline Sore Throat Pain Intensity up to 240 mn Post-dose | -29.1 mm |