Benzydamine hydrochloride for Non-streptococcal pharyngotonsillitis

Inclusion criteria

• {"criterion_text":"- Signed and dated written Informed Consent (ICF). The ICF for participation in the study and consent to data processing will be signed by both parents/legal guardian, while the child will only sign the assent form appropriate for his/her age based on the judgment of the Principal Investigator; Or in cases where one parent is unable to provide consent due to absence, distance, or other impediments, the present parent must provide a self-declaration certifying the absence or impediment of the other parent\n- Male and female patients (aged 6-11 years, limits included). Female patients must be in pre-menarche status at the time of informed consent/assent (where applicable) signature; in the unlikely circumstance that the menarche status changes during the 3 (three) days of the duration of the study, child’s parents/caregiver/legal guardian should immediately inform the Investigator who will then discuss the specific case with the Sponsor and decide whether or not to retain the subject in the study.\n- Recent onset (≤36 hours) of sore throat;\n- Diagnosis of pharyngotonsillitis confirmed by a score ≥5 on the Tonsillo-Pharyngitis Assessment (TPA) scale;\n- A score of at least two points (equal to 1 face) in the WBFPRS score;\n- Oral body temperature ≤38.0°C;\n- No use of benzydamine hydrochloride in any form (e.g. spray, lozenge) in the 24 (twenty-four) hours prior to the enrolment in the study;\n- Negative group A β-hemolytic Streptococcus (S. pyogenes)."}

Exclusion criteria

• {"criterion_text":"- Known hypersensitivity to benzydamine hydrochloride or its excipients (refer to Appendix 1);\n- Any inhaled therapy in the previous week before the first Investigational Medicinal Product (IMP) administration;\n- Any systemic or local (including sprays and mouthwashes) with anti-inflammatories, antipyretics, corticosteroids, local anaesthetics, antiseptics, decongestants, antihistamines, expectorants, antitussives, antibiotics, or natural medications (e.g. herbal infuses, propolis) in the 48 hours prior to enrolment in the study;\n- Participation to a clinical trial within 3 months prior to the inclusion in the study;\n- 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;\n- Any other diseases that present sore throat as concomitant symptoms (e.g., but not limited to, gastroesophageal reflux, exposure to toxic substances, allergic reactions).\n- Diagnosis or suspect of phenylketonuria;\n- Diagnosis or suspect of fructose intolerance;\n- Clinically significant abnormalities at physical examination based on Investigator’s judgement;\n- Intolerance to acetylsalicylic acid or other NSAIDS;\n- History or diagnosis of asthma;\n- Any concomitant disease that compromise breathing (i.e. bronchopneumonia);\n- Severe coughing which causes throat discomfort (as per investigator judgement);\n- Purulent plaques on the tonsils;"}

Primary endpoints

• {"endpoint_text":"- Repeated-measures association during the first 60 minutes after first lozenge placement between change from baseline in the percentage of pharyngotonsillar surface area above the pre-specified temperature threshold, assessed centrally on duplicate infrared images.","definition_or_measurement_approach":"Assessment centrally on duplicate infrared images; repeated-measures association during first 60 minutes after first lozenge placement."}
• {"endpoint_text":"- Repeated-measures association during the first 60 minutes after first lozenge placement between change from baseline in WBFPRS assessed at 5, 10, 15, 20, 25, 30 and 60 minutes.","definition_or_measurement_approach":"WBFPRS (Wong-Baker FACES Pain Rating Scale) assessed at 5, 10, 15, 20, 25, 30 and 60 minutes; repeated-measures association over first 60 minutes."}

Secondary endpoints

• {"endpoint_text":"- Time from first lozenge placement to first clinically meaningful pain reduction (≥2-point decrease in WBFPRS).","definition_or_measurement_approach":"Clinically meaningful pain reduction defined as ≥2-point decrease in WBFPRS; time-to-event measure from first lozenge placement."}
• {"endpoint_text":"- Time from first lozenge placement to first predefined thermographic improvement (defined as a relative reduction from baseline of at least 15% in the percentage of pharyngotonsillar surface area above the prespecified temperature threshold).","definition_or_measurement_approach":"Thermographic improvement defined as ≥15% relative reduction from baseline in the percentage of pharyngotonsillar surface area above the prespecified temperature threshold; time-to-event measure."}
• {"endpoint_text":"- Proportion of participants with clinically meaningful pain reduction at 5, 10, 15, 20, 25, 30, 60 minutes and at 24, 48 and 72 hours.","definition_or_measurement_approach":"Proportion at each scheduled timepoint where clinically meaningful pain reduction (≥2-point decrease in WBFPRS) is observed."}
• {"endpoint_text":"- Mean and median change from baseline in WBFPRS at each scheduled time-point.","definition_or_measurement_approach":"Descriptive statistics (mean, median) of change from baseline in WBFPRS at scheduled time-points."}
• {"endpoint_text":"- Time to complete pain disappearance (WBFPRS = 0).","definition_or_measurement_approach":"Time-to-event where WBFPRS equals 0."}
• {"endpoint_text":"- Number of lozenges taken before complete pain disappearance.","definition_or_measurement_approach":"Count of lozenges used until WBFPRS = 0."}
• {"endpoint_text":"- Descriptive association between change from baseline in the percentage of pharyngotonsillar surface area above the pre-specified temperature threshold and change from baseline in WBFPRS over 24, 48 and 72 hours.","definition_or_measurement_approach":"Descriptive association analyses between thermographic measure and WBFPRS over 24, 48 and 72 hours."}
• {"endpoint_text":"- Supportive analyses referenced to the time of complete lozenge dissolution.","definition_or_measurement_approach":"Supportive analyses using time of complete lozenge dissolution as reference."}
• {"endpoint_text":"- Need for paracetamol and/or antibiotics during the study.","definition_or_measurement_approach":"Recording incidence of paracetamol and/or antibiotic use during study period."}
• {"endpoint_text":"- Safety outcomes including adverse events, vital signs, oral temperature, and physical examination findings.","definition_or_measurement_approach":"Standard safety assessments: adverse event reporting, vital signs, oral temperature, physical exam findings."}
• {"endpoint_text":"- Number and percentage of patients who discontinued the investigational medicinal product, with the reason for discontinuation.","definition_or_measurement_approach":"Descriptive counts and percentages of IMP discontinuations with reasons."}

Italy

Earliest CTIS Part Ii Submission Date

19-03-2026

Latest Decision Or Authorization Date

30-04-2026

Processing Time Days

42

Number Of Sites

1

Number Of Participants

120

Primary sponsor

Full Name

Angelini Pharma Italia Aziende Chimiche Riunite Angelini Francesc O A.C.R.A.F. S.p.A. Enunciabile Anche Angelini Pharma Italia S.p.A. Angelini Pharma S.p.A. A.C.R.A.F. S.p.A. Acraf S.p.A. Angelini S.p.A. Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Italy

Contract research organisations

Name

Prineos S.r.l.

Responsibilities

Sponsor third party with sponsor duties code 10 (contact: office@prineos.com)

Name

Hippocrates Research S.r.l.

Responsibilities

Sponsor third party with sponsor duties including termographic central assessment and other operational duties (codes 1,12,15,2,5,6) (contact: reduce@hippocrates-research.it)

Name

Link Medical Research AS

Responsibilities

Sponsor third party responsible for eTMF system and other duties (codes 15,7) (contact: Ruchika.Kohmaria@linkmedical.eu)

Third parties

• {"country":"Italy","full_name":"Prineos S.r.l.","duties_or_roles":"sponsorDuties codes: [10]","organisation_type":"Pharmaceutical company"}
• {"country":"Italy","full_name":"Hippocrates Research S.r.l.","duties_or_roles":"sponsorDuties codes: [1,12,15 (termographic central assessment),2,5,6]","organisation_type":"Pharmaceutical company"}
• {"country":"Norway","full_name":"Link Medical Research AS","duties_or_roles":"sponsorDuties codes: [15 (eTMF system),7]","organisation_type":"Pharmaceutical company"}