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Efficacy and Safety Study of New Ambroxol Hardboiled Lozenges in Acute Pharyngitis

CompletedPhase 3

Sponsor: Sanofi

Conditions: Pharyngitis

Interventions: ambroxol BIH1526, placebo

Countries: South Africa

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (1)

Johannesburg, South Africa