Phase IV study comparing the efficacy and safety of an alcohol-free formulation of 0.15% benzydamine hydrochloride spray and benzydamine hydrochloride 3mg lozenges in paediatric patients (6-12 years) with sore throat. - BeChild (Benzydamine in Child for Sore throat pain relief)

Angelini Pharma S.p.A.0 sites356 target enrollmentJanuary 17, 2023

Overview

No summary available.

Registry

who.int

Start Date

January 17, 2023

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Angelini Pharma S.p.A.

•1\.Male and female patients (aged 6\-12 years, limits included);
•2\.Recent onset (\=3 days) of sore throat;
•3\.Diagnosis of tonsillopharyngitis confirmed by a score \=5 on TPA;
•4\.A score of at least two points (equal to 1 face) in the WBS score;
•5\.Signed and dated written Informed Consent: The ICF for participation in the study and consent to data processing will be signed by the parents/legal guardian while the child will sign the assent form only.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 356
•F.1\.2 Adults (18\-64 years) no
•F.1\.2\.1 Number of subjects for this age range
•F.1\.3 Elderly (\>\=65 years) no

•1\.Known hypersensitivity to benzydamine hydrochloride or its excipients;
•2\.Phenylketonuria;
•3\.Clinically significant abnormalities at physical examination based on Investigator’s judgement;
•4\.Intolerance to acetylsalicylic acid or other NSAIDS;
•5\.History or diagnosis of asthma;
•6\.Any concomitant disease that compromise breathing (i.e. bronchopneumonia);
•7\.Severe coughing which causes throat discomfort (Investigator judgement);
•8\.Purulent plaques on the tonsils;
•9\.Any inhaled therapy in the previous week before the first IMP administration;
•10\.Use of antibiotics for an acute disease in the 7 days before randomization; any sustained release analgesic within 24 hours of IMP administration; any medications for cold and flu (i.e., decongestants, antihistamines, expectorants, antitussives), immediate release analgesic or antipyretic within 4 hours of IMP administration;