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

NCT03583658 | Completed Phase 3

• 2 other identifiers: LPS15328U1111-1202-9392
• Study Type: interventional
• Target: 390
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change in SPID

  hour 24

• 3-hour patient assessment of efficacy

  hour 3

• 24-hour patient assessment of efficacy

  hour 24

• Adverse events

  baseline to day 4

• Patient assessment of tolerability

  hour 3, hour 24 and day 2, day 3 or day 4

Study Arms (2)

Ambroxol hydrochloride (BIH1526)

ACTIVE COMPARATOR

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

Drug: ambroxol BIH1526

Placebo

PLACEBO COMPARATOR

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

Drug: placebo

Interventions

ambroxol BIH1526 DRUG

Pharmaceutical form: lozenges Route of administration: oromucosal

Ambroxol hydrochloride (BIH1526)

placebo DRUG

Pharmaceutical form: lozenges Route of administration: oromucosal

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Investigational Site Number 7100005

Johannesburg, South Africa

Location

Related Publications (1)

• Sousa R, Lakha DR, Brette S, Hitier S. A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Ambroxol Hard-Boiled Lozenges in Patients with Acute Pharyngitis. Pulm Ther. 2019 Dec;5(2):201-211. doi: 10.1007/s41030-019-00100-w. Epub 2019 Oct 18.

  PMID: 32026411 DERIVED

MeSH Terms

Conditions

Pharyngitis

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2018
• First Posted: July 11, 2018
• Study Start: June 30, 2018
• Primary Completion: September 2, 2018
• Study Completion: September 2, 2018
• Last Updated: April 25, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share

Locations

ZA (1)