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

• ClinicalTrials.gov Identifier: NCT03583658
• Recruitment Status: Completed
• First Posted: July 11, 2018
• Last Update Posted: September 25, 2018
• Sponsor: Sanofi
• Information provided by (Responsible Party): Sanofi

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.

Condition or disease	Intervention/treatment	Phase
Pharyngitis	Drug: ambroxol BIH1526; Drug: placebo	Phase 3

Detailed Description:

Duration per participant is up to 4 days.

Study Design

• 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

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Ambroxol hydrochloride (BIH1526); One lozenge 20 mg on as-needed basis, up to 6 times per day	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	Drug: placebo; Pharmaceutical form: lozenges Route of administration: oromucosal

Outcome Measures

Primary Outcome Measures :

1. 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)

Secondary Outcome Measures :

1. 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)
2. 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
3. 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
4. Adverse events [ Time Frame: baseline to day 4 ]
   Incidence of the adverse events
5. 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
6. 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

Eligibility Criteria

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

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.

Contacts and Locations

Locations

South Africa

Investigational Site Number 7100005

Johannesburg, South Africa

Sponsors and Collaborators

Sanofi

Investigators

• Study Director: Clinical Sciences & Operations; Sanofi

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Sanofi
• ClinicalTrials.gov Identifier: NCT03583658
• Other Study ID Numbers: LPS15328; U1111-1202-9392 ( Other Identifier: UTN )
• First Posted: July 11, 2018
• Last Update Posted: September 25, 2018
• Last Verified: September 2018

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://www.clinicalstudydatarequest.com/

• 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

Additional relevant MeSH terms:

Pharyngitis; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Ambroxol; Expectorants; Respiratory System Agents