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 个研究点目标入组 356 人开始时间: 2023年4月12日最近更新: 2024年2月19日

适应症

试验速览

暂无简介。

•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
•F.1.3.1 Number of subjects for this age range

•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;
•11.Use of any lozenge, mouthwash, spray or menthol-containing products within 2 hours prior to IMP administration;
•12.Participation to a clinical trial within 3 months prior to the inclusion in the
•13.Parents/legal guardian, who are unable to comprehend the full nature and
•purpose of the study and to comply with the requirements of the study;
•14.SARS-CoV2 positivity;
•15.Female patients of child-bearing potential, who are pregnant;
•16. Any other diseases that present sore throat as concomitant symptoms.

发起方

Angelini Pharma S.p.A.