acute sore throat MedDRA version: 23.1 Level: LLT Classification code 10041367 Term: Sore throat System Organ Class: 100000004855
Conditions
Interventions
Trade Name: Tantum Verde 0,15% oromucosal spray, solution
Product Name: Tantum Verde 0,15% oromucosal spray, solution
Pharmaceutical Form: Oromucosal spray, solution
Trade Name: Tantum Verde P 3mg l
Sponsors
Angelini Pharma S.p.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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 study; 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to assess the local analgesic effect of benzydamine hydrochloride (spray or lozenges) in reducing sore throat pain at T15 min after a single dose administration to paediatric patients. ;Secondary Objective: -To assess the local analgesic effect in reducing sore throat pain at T5 min, T10 min, T30 min and T45 min, after a single-dose administration of benzydamine hydrochloride spray or lozenges. -To assess the local analgesic effect in reducing sore throat pain, after 3 and 7 days of treatment, after a multiple-dose administration of benzydamine hydrochloride spray or lozenges. -To assess the safety and the tolerability of benzydamine hydrochloride spray or lozenges by collecting treatment-emergent adverse events (TEAEs), frequency, serious AEs, occurrence, changes in vital signs, in physical examination and in clinical symptoms after a single and repeated doses (up to a maximum of 7 days) of a topically administered benzydamine hydrochloride 0.15% spray in comparison with benzydamine hydrochloride lozenges 3mg. ;Primary end point(s): Percentage of responders defined as patients reporting a reduction of at least one face (equal to 2 points) in the WBS score (Wong-Baker Faces Pain Rating Scale) at T15 min after the first application of benzydamine hydrochloride 0.15% spray or benzydamine hydrochloride 3mg lozenges vs baseline. The WBS uses 6 different faces from smile to crying to describe the pain intensity of children aged 3 and above, from no hurt (0 point) to hurts worst (10 point), with a 2-point interval. ;Timepoint(s) of evaluation of this end point: T15 min after the first application of benzydamine hydrochloride 0.15% spray or benzydamine hydrochloride 3mg lozenges. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Percentage of patients reporting a reduction of at least one face (equal to two points) in the WBS score vs baseline at T5 min, T10 min, T30 min, T45 min after a single dose administration. • Percentage of patients with sore throat disappearance, defined as WBS score equal to 0, and percentage of patients reporting a reduction of the WBS score of 2 points (equal to 1 face) vs baseline evaluated at full 3 and/or 7 days after multiple dosing. • Evaluation of the frequency of AEs/serious AEs, changes in vital signs, in physical examination and in clinical symptoms vs baseline after a single and repeated doses (up to a maximum of 7 days) of a topically administered benzydamine hydrochloride 0.15% spray in comparison with benzydamine hydrochloride lozenges 3mg. • The treatment effect in reducing sore throat intensity through a TPA scale at V1, V2 and/or V3/ETTV. ;Timepoint(s) of evaluation of this end point: -Reduction of pain at T5 min, T10 min, T30 min, T45 min after a single dose administration. -Disappearance of sore throat pain at 3 and/or 7 days after multiple dosing. -Reduction of the WBS score at day 3 and/or 7 -evaluation and frequency of AEs changes in vital signs, and in physical examination and in clinical symptoms vs baseline after a single and repeated doses (up to a maximum of 7 days) -The treatment effect after 3 and/or 7 days treatment | — |
Countries
Bulgaria, Hungary
Contacts
Public ContactStudy Manager
Angelini Pharma S.p.A.
Outcome results
None listed