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Completed

NCT Number: NCT03583658

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

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.

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Key information

Conditions

Pharyngitis Infections Otorhinolaryngologic Diseases Pharyngeal Diseases Respiratory Tract Diseases Respiratory Tract Infections Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Investigational Site Number 7100005

Johannesburg, South Africa

About this study

Duration per participant is up to 4 days.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ambroxol BIH1526

Drug

Pharmaceutical form: lozenges Route of administration: oromucosal

Placebo

Drug

Pharmaceutical form: lozenges Route of administration: oromucosal

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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

Acronym: DELICIOUS

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jul 11, 2018
Registry last updated
Apr 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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