Clinical Trials Register

Summary
EudraCT Number:	2022-003285-20
Sponsor's Protocol Code Number:	030(Z)MD22061
National Competent Authority:	Hungary - National Institute of Pharmacy
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2023-01-17
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Hungary - National Institute of Pharmacy

A.2

EudraCT number

2022-003285-20

A.3

Full title of the trial

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.

4-es fázisú vizsgálat az alkoholmentes benzidamin hidroklorid 0,15% szájnyálkahártya spray és a benzidamin hidroklorid 3 mg cukorka hatásosságának és biztonságosságának összehasonlítására 6-12 éves gyermekek akut torokfájása esetén

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Study comparing the effects of two different dosage forms (mouth spray and lozenges) of the same medication (benzydamine) in children aged 6-12 years with sore throat.

Az alkoholmentes benzidamin hidroklorid 0,15 %-os s sray és a 3 mg-os cukorka hatékonyságának és biztonságosságának összehasonlító vizsgálata 6-12 éves gyermekek akut torokfájása esetén.

A.3.2

Name or abbreviated title of the trial where available

BeChild (Benzydamine in Child for Sore throat pain relief)

BeChild (Benzidamin gyermekek akut torokfájásában)

A.4.1

Sponsor's protocol code number

030(Z)MD22061

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Angelini Pharma S.p.A.
B.1.3.4	Country	Italy
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Angelini Pharma S.p.A.
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Angelini Pharma S.p.A.
B.5.2	Functional name of contact point	Study Manager
B.5.3	Address:
B.5.3.1	Street Address	Viale Amelia 70
B.5.3.2	Town/ city	Rome
B.5.3.3	Post code	00181
B.5.3.4	Country	Italy
B.5.4	Telephone number	00393472274815
B.5.6	E-mail	martina.barcaroli@angelinipharma.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Tantum Verde 0,15% oromucosal spray, solution
D.2.1.1.2	Name of the Marketing Authorisation holder	Angelini Pharma S.p.A., Viale Amelia 70, 00181, Rome, Italy
D.2.1.2	Country which granted the Marketing Authorisation	Italy
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Tantum Verde 0,15% oromucosal spray, solution
D.3.4	Pharmaceutical form	Oromucosal spray, solution
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Local use (Noncurrent) Oromucosal use
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Tantum Verde P 3mg lozenges mint flavour
D.2.1.1.2	Name of the Marketing Authorisation holder	Angelini Pharma S.p.A., Viale Amelia 70, 00181 Rome, Italy
D.2.1.2	Country which granted the Marketing Authorisation	Italy
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Tantum Verde P 3 mg lozenges mint flavour
D.3.4	Pharmaceutical form	Lozenge
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Local use (Noncurrent) Oromucosal use
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

acute sore throat

E.1.1.1

Medical condition in easily understood language

acute sore throat

E.1.1.2

Therapeutic area

Diseases [C] - Ear, nose and throat diseases [C09]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	23.1
E.1.2	Level	LLT
E.1.2	Classification code	10041367
E.1.2	Term	Sore throat
E.1.2	System Organ Class	100000004855

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

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.

E.2.2

Secondary objectives of the trial

-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.
-To assess the sore throat intensity through the TPA (Tonsillo Pharyngitis Assessment) scale at V1, V2 and/or at V3/ETTV.

E.2.3

Trial contains a sub-study

E.3

Principal 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.

E.4

Principal 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.

E.5 End points

E.5.1

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.

E.5.1.1

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.

15 perccel a 0,15%-os benzidamin-hidroklorid spray vagy benzidamin-hidroklorid 3 mg-os cukorka első alkalmazása után.

E.5.2

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.

E.5.2.1

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

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

Yes

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

Yes

F.1.1

Number of subjects for this age range:

356

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

Yes

F.1.1.5.1

Number of subjects for this age range:

300

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.1.6.1

Number of subjects for this age range:

F.1.2

Adults (18-64 years)

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

140

F.4.2

For a multinational trial

F.4.2.1

In the EEA

356

F.4.2.2

In the whole clinical trial

356

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

non

nem

G. Investigator Networks to be involved in the Trial
G.4 Investigator Network to be involved in the Trial: 1

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2023-03-13

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2023-03-02

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2024-01-18

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials