Efficacy and Safety Study of New Ambroxol Hardboiled Lozenges in Acute Pharyngitis (DELICIOUS)
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ClinicalTrials.gov Identifier: NCT03583658 |
Recruitment Status :
Completed
First Posted : July 11, 2018
Last Update Posted : April 25, 2022
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pharyngitis | Drug: ambroxol BIH1526 Drug: placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 390 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | June 30, 2018 |
Actual Primary Completion Date : | September 2, 2018 |
Actual Study Completion Date : | September 2, 2018 |
Arm | Intervention/treatment |
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Active Comparator: Ambroxol hydrochloride (BIH1526)
One lozenge 20 mg on as-needed basis, up to 6 times per day
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Drug: ambroxol BIH1526
Pharmaceutical form: lozenges Route of administration: oromucosal |
Placebo Comparator: Placebo
One lozenge on as-needed basis, up to 6 times per day
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Drug: placebo
Pharmaceutical form: lozenges Route of administration: oromucosal |
- Change in pain intensity difference (PID) [ Time Frame: 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)
- Change in SPID [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: hour 24 ]Patient assessment of efficacy after 24 hours of the first study drug intake using a 5-point VRS
- Adverse events [ Time Frame: baseline to day 4 ]Incidence of the adverse events
- Patient assessment of tolerability [ Time Frame: 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
- Final assessment of tolerability [ Time Frame: day 4 ]Investigator and patient assessment of tolerability on Day 4 using a 5-point VRS, where 0 = poor and 4 = excellent

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03583658
South Africa | |
Investigational Site Number 7100005 | |
Johannesburg, South Africa |
Study Director: | Clinical Sciences & Operations | Sanofi |
Responsible Party: | Sanofi |
ClinicalTrials.gov Identifier: | NCT03583658 |
Other Study ID Numbers: |
LPS15328 U1111-1202-9392 ( Other Identifier: UTN ) |
First Posted: | July 11, 2018 Key Record Dates |
Last Update Posted: | April 25, 2022 |
Last Verified: | April 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Pharyngitis Respiratory Tract Infections Infections Pharyngeal Diseases Stomatognathic Diseases |
Respiratory Tract Diseases Otorhinolaryngologic Diseases Ambroxol Expectorants Respiratory System Agents |