CompletedPhase 3

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

South Africa390 participantsStarted 2018-06-30

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Change in pain intensity difference (PID)

Timeframe: hour 3

Trial details

NCT IDNCT03583658

SponsorSanofi

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-09-02

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