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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03583658
Recruitment Status : Completed
First Posted : July 11, 2018
Last Update Posted : September 25, 2018
Sponsor:
Information provided by (Responsible Party):
Sanofi

Tracking Information
First Submitted Date  ICMJE June 18, 2018
First Posted Date  ICMJE July 11, 2018
Last Update Posted Date September 25, 2018
Actual Study Start Date  ICMJE June 30, 2018
Actual Primary Completion Date September 2, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety Study of New Ambroxol Hardboiled Lozenges in Acute Pharyngitis
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Pharyngitis
Intervention  ICMJE
  • Drug: ambroxol BIH1526
    Pharmaceutical form: lozenges Route of administration: oromucosal
  • Drug: placebo
    Pharmaceutical form: lozenges Route of administration: oromucosal
Study Arms  ICMJE
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 28, 2018)
390
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2, 2018
Actual Primary Completion Date September 2, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE South Africa
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03583658
Other Study ID Numbers  ICMJE 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  ICMJE
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/
Responsible Party Sanofi
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Sciences & Operations Sanofi
PRS Account Sanofi
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP