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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

390 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-30

Study Completion Date

2018-09-02

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.

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Detailed Description

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Duration per participant is up to 4 days.

Conditions

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Pharyngitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Ambroxol hydrochloride (BIH1526)

One lozenge 20 mg on as-needed basis, up to 6 times per day

Group Type ACTIVE_COMPARATOR

ambroxol BIH1526

Intervention Type DRUG

Pharmaceutical form: lozenges Route of administration: oromucosal

Placebo

One lozenge on as-needed basis, up to 6 times per day

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Pharmaceutical form: lozenges Route of administration: oromucosal

Interventions

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ambroxol BIH1526

Pharmaceutical form: lozenges Route of administration: oromucosal

Intervention Type DRUG

placebo

Pharmaceutical form: lozenges Route of administration: oromucosal

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No