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

Primary Purpose

Pharyngitis

Status
Completed
Phase
Phase 3
Locations
South Africa
Study Type
Interventional
Intervention
ambroxol BIH1526
placebo
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pharyngitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Investigational Site Number 7100005

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Ambroxol hydrochloride (BIH1526)

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)
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
24-hour patient assessment of efficacy
Patient assessment of efficacy after 24 hours of the first study drug intake using a 5-point VRS
Adverse events
Incidence of the adverse events
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
Final assessment of tolerability
Investigator and patient assessment of tolerability on Day 4 using a 5-point VRS, where 0 = poor and 4 = excellent

Full Information

First Posted
June 18, 2018
Last Updated
April 21, 2022
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT03583658
Brief Title
Efficacy and Safety Study of New Ambroxol Hardboiled Lozenges in Acute Pharyngitis
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
June 30, 2018 (Actual)
Primary Completion Date
September 2, 2018 (Actual)
Study Completion Date
September 2, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pharyngitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
390 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ambroxol hydrochloride (BIH1526)
Arm Type
Active Comparator
Arm Description
One lozenge 20 mg on as-needed basis, up to 6 times per day
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
One lozenge on as-needed basis, up to 6 times per day
Intervention Type
Drug
Intervention Name(s)
ambroxol BIH1526
Intervention Description
Pharmaceutical form: lozenges Route of administration: oromucosal
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Pharmaceutical form: lozenges Route of administration: oromucosal
Primary Outcome Measure Information:
Title
Change in pain intensity difference (PID)
Description
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)
Time Frame
hour 3
Secondary Outcome Measure Information:
Title
Change in SPID
Description
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)
Time Frame
hour 24
Title
3-hour patient assessment of efficacy
Description
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
Time Frame
hour 3
Title
24-hour patient assessment of efficacy
Description
Patient assessment of efficacy after 24 hours of the first study drug intake using a 5-point VRS
Time Frame
hour 24
Title
Adverse events
Description
Incidence of the adverse events
Time Frame
baseline to day 4
Title
Patient assessment of tolerability
Description
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
Time Frame
hour 3, hour 24 and day 2, day 3 or day 4
Title
Final assessment of tolerability
Description
Investigator and patient assessment of tolerability on Day 4 using a 5-point VRS, where 0 = poor and 4 = excellent
Time Frame
day 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number 7100005
City
Johannesburg
Country
South Africa

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
32026411
Citation
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.
Results Reference
derived

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

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