Pharyngitis
Conditions
Brief summary
Primary Objective: To assess the efficacy of the new hard boiled Ambroxol lozenges 20 mg for the relief of sore throat pain in patients with acute pharyngitis. Secondary Objective: To assess the safety of the new hard boiled Ambroxol lozenges 20 mg in patients with acute pharyngitis.
Detailed description
Duration per participant is up to 4 days.
Interventions
DRUGambroxol BIH1526
Pharmaceutical form: lozenges Route of administration: oromucosal
DRUGplacebo
Pharmaceutical form: lozenges Route of administration: oromucosal
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult male or female patients complaining of sore throat due to acute pharyngitis with an onset no more than 72 hours prior to Visit 1. * Patients with a score of 6 or greater on a 0-10-point pain intensity numerical rating scale. * Signed written informed consent.
Exclusion criteria
Patients suffering from pharyngitis of bacterial origin. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain intensity difference (PID) | hour 3 | Change from baseline to hour 3 in time-weighted average of PID after the first lozenge, expressed as the ratio of the predose baseline, sum of PID (SPIDnorm, 0-3h) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 3-hour patient assessment of efficacy | hour 3 | Patient assessment of efficacy after 3 hours of the first study drug intake using a 5-point verbal rating scale (VRS) to rate whether the trial medication relieves sore throat pain, where 0 = poor and 4 = excellent |
| 24-hour patient assessment of efficacy | hour 24 | Patient assessment of efficacy after 24 hours of the first study drug intake using a 5-point VRS |
| Change in SPID | hour 24 | Change from baseline to hour 24 in time-weighted average of PID after the first lozenge, expressed as the ratio of the predose baseline, sum of PID (SPIDnorm, 0-24h) |
| Patient assessment of tolerability | hour 3, hour 24 and day 2, day 3 or day 4 | Patient assessment of tolerability after 3 hours, Day 1, on Day 2, Day 3 and Day 4 using a 5-point VRS, where 0 = poor and 4 = excellent |
| Final assessment of tolerability | day 4 | Investigator and patient assessment of tolerability on Day 4 using a 5-point VRS, where 0 = poor and 4 = excellent |
| Adverse events | baseline to day 4 | Incidence of the adverse events |
Countries
South Africa
Outcome results
None listed