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

Study Overview
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Brief Summary
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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
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Duration per participant is up to 4 days.

Official Title
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A Randomised, Double-blind, Placebo Controlled, Parallel Group, Multicentre Trial to Assess the Efficacy and Safety of Ambroxol Lozenges 20 mg (Hard Boiled Lozenges) Versus Placebo for the Relief of Sore Throat Pain in Patients With Acute Pharyngitis

Conditions
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Pharyngitis

Intervention / Treatment
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* Drug: ambroxol BIH1526
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ambroxol hydrochloride (BIH1526)<br>One lozenge 20 mg on as-needed basis, up to 6 times per day | Drug: ambroxol BIH1526<br>* Pharmaceutical form: lozenges Route of administration: oromucosal<br>|
| Placebo Comparator: Placebo<br>One lozenge on as-needed basis, up to 6 times per day | Drug: placebo<br>* Pharmaceutical form: lozenges Route of administration: oromucosal<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | hour 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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 | 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 | hour 24 | 
| Adverse events | Incidence of the adverse events | 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 | 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 | day 4 |