Clinical study for patients aged between 6 and 11 years, suffering from non-streptococcal pharyngotonsillitis, who will take the marketed drug Tantum Verde 3 mg mint-flavored lozenges, to evaluate their pain-relieving effect.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

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.

Participant type

Pediatric, Patients

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

Decision date (initial)

2026-04-30

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Angelini Pharma SpA

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others

To estimate the association and temporal concordance between change from baseline in the percentage of pharyngotonsillar surface area above the pre-specified temperature threshold and change from baseline in WBFPRS during the first 60 minutes after first lozenge placement in the mouth.

Secondary objectives 7

1. To describe the time to first clinically meaningful pain reduction, defined as a decrease of at least 2 points in WBFPRS.
2. To describe the time to first meaningful thermographic improvement, defined as a relative reduction from baseline of at least 15% in the percentage of pharyngotonsillar surface area above the pre-specified temperature threshold.
3. To describe the association between change from baseline in the percentage of pharyngotonsillar surface area above the pre-specified temperature threshold and pain evolution over the full 72-hour study period.
4. To describe the proportion of participants with clinically meaningful pain reduction at each scheduled timepoint.
5. To describe changes from baseline in WBFPRS and in the percentage of pharyngotonsillar surface area above the pre-specified temperature threshold at each time-point.
6. To perform supportive analyses referenced to the time of complete lozenge dissolution.
7. To evaluate short-term safety and tolerability of benzydamine hydrochloride during labelled use.

Conditions and MedDRA coding

NON STREPTOCOCCAL PHARYNGOTONSILLITIS

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. 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
2. 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.
3. Recent onset (≤36 hours) of sore throat;
4. Diagnosis of pharyngotonsillitis confirmed by a score ≥5 on the Tonsillo-Pharyngitis Assessment (TPA) scale;
5. A score of at least two points (equal to 1 face) in the WBFPRS score;
6. Oral body temperature ≤38.0°C;
7. 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;
8. Negative group A β-hemolytic Streptococcus (S. pyogenes).

Exclusion criteria 14

1. Known hypersensitivity to benzydamine hydrochloride or its excipients (refer to Appendix 1);
2. Diagnosis or suspect of phenylketonuria;
3. Diagnosis or suspect of fructose intolerance;
4. Clinically significant abnormalities at physical examination based on Investigator’s judgement;
5. Intolerance to acetylsalicylic acid or other NSAIDS;
6. History or diagnosis of asthma;
7. Any concomitant disease that compromise breathing (i.e. bronchopneumonia);
8. Severe coughing which causes throat discomfort (as per investigator judgement);
9. Purulent plaques on the tonsils;
10. Any inhaled therapy in the previous week before the first Investigational Medicinal Product (IMP) administration;
11. 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;
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. Any other diseases that present sore throat as concomitant symptoms (e.g., but not limited to, gastroesophageal reflux, exposure to toxic substances, allergic reactions).

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. 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.
2. 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.

Secondary endpoints 11

1. Time from first lozenge placement to first clinically meaningful pain reduction (≥2-point decrease in WBFPRS).
2. 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).
3. Proportion of participants with clinically meaningful pain reduction at 5, 10, 15, 20, 25, 30, 60 minutes and at 24, 48 and 72 hours.
4. Mean and median change from baseline in WBFPRS at each scheduled time-point.
5. Time to complete pain disappearance (WBFPRS = 0).
6. Number of lozenges taken before complete pain disappearance.
7. 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.
8. Supportive analyses referenced to the time of complete lozenge dissolution.
9. Need for paracetamol and/or antibiotics during the study.
10. Safety outcomes including adverse events, vital signs, oral temperature, and physical examination findings.
11. Number and percentage of patients who discontinued the investigational medicinal product, with the reason for discontinuation.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

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.

Sponsor organisation

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.

Address

Viale Amelia 70

City

Rome

Postcode

00181

Country

Italy

Scientific contact point

Organisation

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.

Contact name

Valeria Tellone

Public contact point

Organisation

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.

Contact name

Valeria Tellone

Third parties 3

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 14 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications