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

Pharyngitis Clinical Trial

— DELICIOUS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03583658
• Other study ID #: LPS15328
• Secondary ID: U1111-1202-9392
• Status: Completed
• Phase: Phase 3
• Start date: June 30, 2018
• Est. completion date: September 2, 2018

Study information

• Verified date: April 2022
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Duration per participant is up to 4 days.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 390
• Est. completion date: September 2, 2018
• Est. primary completion date: September 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pharyngitis

Intervention

Drug:
• ambroxol BIH1526
Pharmaceutical form: lozenges Route of administration: oromucosal
• placebo
Pharmaceutical form: lozenges Route of administration: oromucosal

Locations

Country	Name	City	State
South Africa	Investigational Site Number 7100005	Johannesburg

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Adverse events	Incidence of the adverse events	baseline to day 4
Secondary	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
Secondary	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