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

Sanofi390 enrolled

Overview

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.

Duration per participant is up to 4 days.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

390

Conditions

Pharyngitis

Interventions

ambroxol BIH1526DRUG

Pharmaceutical form: lozenges Route of administration: oromucosal

placeboDRUG

Pharmaceutical form: lozenges Route of administration: oromucosal

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Investigational Site Number 7100005

Johannesburg, South Africa

Outcomes

Primary Outcomes

Change in pain intensity difference (PID)

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)

Time frame: hour 3

Secondary Outcomes

Change in SPID

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)

Time frame: hour 24

3-hour patient assessment of efficacy

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

Time frame: hour 3

24-hour patient assessment of efficacy

Patient assessment of efficacy after 24 hours of the first study drug intake using a 5-point VRS

Time frame: hour 24

Adverse events

Incidence of the adverse events

Time frame: baseline to day 4

Patient assessment of tolerability

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

Time frame: hour 3, hour 24 and day 2, day 3 or day 4

Final assessment of tolerability

Investigator and patient assessment of tolerability on Day 4 using a 5-point VRS, where 0 = poor and 4 = excellent

Data from ClinicalTrials.gov

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