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

NCT03583658 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 390

Last updated 2022-04-25

No results posted yet for this study

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.

Conditions

  • Pharyngitis

Interventions

DRUG

ambroxol BIH1526

Pharmaceutical form: lozenges Route of administration: oromucosal

DRUG

placebo

Pharmaceutical form: lozenges Route of administration: oromucosal

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-30
Primary Completion
2018-09-02
Completion
2018-09-02

Countries

  • South Africa

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03583658 on ClinicalTrials.gov