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: April 25, 2022
• Sponsor: Sanofi
• Information provided by (Responsible Party): Sanofi

Tracking Information

• First Submitted Date: June 18, 2018
• First Posted Date: July 11, 2018
• Last Update Posted Date: April 25, 2022
• Actual Study Start Date: June 30, 2018
• Actual Primary Completion Date: September 2, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 28, 2018)

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)

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 28, 2018)

• 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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Efficacy and Safety Study of New Ambroxol Hardboiled Lozenges in Acute Pharyngitis
• 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

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 Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Pharyngitis

Intervention

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

Study Arms

• Active Comparator: Ambroxol hydrochloride (BIH1526)
  One lozenge 20 mg on as-needed basis, up to 6 times per day
  Intervention: Drug: ambroxol BIH1526
• Placebo Comparator: Placebo
  One lozenge on as-needed basis, up to 6 times per day
  Intervention: Drug: placebo

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 28, 2018): 390
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: September 2, 2018
• Actual Primary Completion Date: September 2, 2018 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: South Africa

Administrative Information

• NCT Number: NCT03583658
• Other Study ID Numbers: LPS15328; U1111-1202-9392 ( Other Identifier: UTN )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• 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

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

• Current Responsible Party: Sanofi
• Original Responsible Party: Same as current
• Current Study Sponsor: Sanofi
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Clinical Sciences & Operations; Sanofi

• PRS Account: Sanofi
• Verification Date: April 2022