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

• Status: Completed
• Trial end date: 2018-09-02
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Ambroxol

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.