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

Phase 3

Completed

• Conditions: Pharyngitis
• Interventions: Drug: ambroxol BIH1526; Drug: placebo

• Registration Number: NCT03583658
• Lead Sponsor: Sanofi

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.

Detailed Description

Duration per participant is up to 4 days.

Study Timeline

• Study First Submitted: 2018-06-18
• Study First Submitted QC: 2018-06-28
• Study Start: 2018-06-30
• Study First Posted: 2018-07-11
• Primary Completion: 2018-09-02
• Study Completion: 2018-09-02
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-21
• Last Update Posted: 2022-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 390

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ambroxol hydrochloride (BIH1526)	ambroxol BIH1526	One lozenge 20 mg on as-needed basis, up to 6 times per day
Placebo	placebo	One lozenge on as-needed basis, up to 6 times per day

Primary Outcome Measures

Name	Time	Method
Change in pain intensity difference (PID)	hour 3	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)

Secondary Outcome Measures

Name	Time	Method
Change in SPID	hour 24	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)
3-hour patient assessment of efficacy	hour 3	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
24-hour patient assessment of efficacy	hour 24	Patient assessment of efficacy after 24 hours of the first study drug intake using a 5-point VRS
Adverse events	baseline to day 4	Incidence of the adverse events
Final assessment of tolerability	day 4	Investigator and patient assessment of tolerability on Day 4 using a 5-point VRS, where 0 = poor and 4 = excellent
Patient assessment of tolerability	hour 3, hour 24 and day 2, day 3 or day 4	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

Trial Locations

Locations (1)

Investigational Site Number 7100005; 🇿🇦 Johannesburg, South Africa