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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

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sore Throat

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




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



Information from the National Library of Medicine

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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.


Information from the National Library of Medicine

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


Locations
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South Africa
Investigational Site Number 7100005
Johannesburg, South Africa
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Clinical Sciences & Operations Sanofi

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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT03583658     History of Changes
Other Study ID Numbers: LPS15328
U1111-1202-9392 ( Other Identifier: UTN )
First Posted: July 11, 2018    Key Record Dates
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/

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