Clinical Trials Register

Summary
EudraCT Number:	2019-003257-29
Sponsor's Protocol Code Number:	030(Z)WO19176
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:	2019-12-23
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

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A. Protocol Information

A.1

Member State Concerned

Hungary - National Institute of Pharmacy

A.2

EudraCT number

2019-003257-29

A.3

Full title of the trial

Phase IV study comparing the efficacy and safety of Benzydamine hydrochloride 0,3% oromucosal spray and Benzydamine hydrochloride 3 mg lozenges in patients with acute sore throat.

4-es fázisú vizsgálat a Benzydamine hydrochloride 0,3% szájnyálkahártya spray és a Benzydamine hydrochloride 3 mg szopogatós tabletta hatásosságának és biztonságosságának összehasonlítására akut torokfájás esetén.

A.3.1

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

Study comparing the efficacy and safety of Benzydamine hydrochloride 0,3% oromucosal spray and Benzydamine hydrochloride 3 mg lozenges in patients with acute sore throat.

A vizsgálat összehasonlítja a Benzydamine hydrochloride 0,3%-os szájnyálkahártya spray és a 3 mg-os szopogatós tabletta hatásosságánt és biztonságosságát akut torokfájás esetén.

A.3.2

Name or abbreviated title of the trial where available

BePaiR study (Benzydamine in Sore Throat Pain Relief).

A.4.1

Sponsor's protocol code number

030(Z)WO19176

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 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 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 S.p.A.
B.5.2	Functional name of contact point	Study Manager
B.5.3	Address:
B.5.3.1	Street Address	P.le della Stazione
B.5.3.2	Town/ city	S. Palomba - Pomezia
B.5.3.3	Post code	00071
B.5.3.4	Country	Italy
B.5.4	Telephone number	390691045567
B.5.5	Fax number	390678332434
B.5.6	E-mail	carmelina.valerio@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 0,30% oromucosal spray, solution
D.2.1.1.2	Name of the Marketing Authorisation holder	Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A. Viale Amelia, 70 - 00181 Roma
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 0,30% 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 3 mg lozenges mint flavour
D.2.1.1.2	Name of the Marketing Authorisation holder	Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A. Viale Amelia, 70 - 00181 Roma.
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

Akut torokfájás

E.1.1.1

Medical condition in easily understood language

acute sore throat

Akut torokfájás

E.1.1.2

Therapeutic area

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

MedDRA Classification

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 efficacy of benzydamine hydrochloride (spray or lozenges), in sore throat pain relief, at 2 minutes (T2 min) after a single dose administration.

Az elsődleges végpont a torokfájás enyhítését célzó benzydamine hydrochloride (spray vagy szopogatós tabletta) hatásosságának kiértékelése 2 perccel (T2 perc) az egyszeri adag alkalmazása után.

E.2.2

Secondary objectives of the trial

• to add. evaluate if a first perceived sore throat relief is experienced already at 1 min, after a single-dose IMP spray or lozenges;
• to evaluate the meaningful sore throat relief after a single-dose of IMP spray or lozenges, at timepoints (min): T5;T10;T15;T30;T60; T120;
• to assess the sore throat relief up to T240 min after a single-dose of IMP spray or lozenges;
• to assess the effect of IMP spray or lozenges on difficulty swallowing and swollen throat at timepoints (min): T5;T10;T15;T30;T60;T120;
• to describe any differences from baseline (and betw. 2 IMP treatments) in terms of effect of IMP (spray or lozenges) on different characteristics of ST pain and discomfort after 60 min,120 min;
• to assess the sore throat intensity across the study, the pharyngeal inflammation status and the Patient Satisfaction for the received medication, at the end of the treatment;
• to assess the safety of IMP spray or lozenges when locally applied up to a 7 days treatment period.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Adult male and female patients (aged 18 - 75 years, limits included) with recent onset (≤3 days) of sore throat and a diagnosis of tonsillopharyngitis confirmed by:
a. Presence of at least one symptom of URTI in the previous 24 h on the URTI questionnaire;
b. Sore throat pain intensity score ≥ 60 mm on Sore Throat Pain Intensity Scale (STPIS);
c. A score ≥ 5 on Tonsillo-Pharingytis Assessment (TPA);
2. Women of childbearing potential or with no menses for a period < 12 months must have a negative pregnancy test at Visit 0 and have to agree not to start a pregnancy from the signature of the informed consent up to the Visit 2, using an appropriate birth control method such as combined oestrogen-progestin containing hormonal contraceptives (e.g., oral, injectable, transdermal), progestin-only hormonal contraceptives (e.g., oral, injectable, implantable), intrauterine device (IUD) or Intrauterine hormone-releasing System (IUS) in combination with male condom, bilateral tubal occlusion, vasectomised partner, sexual abstinence. The following definitions will be considered:
• Woman of childbearing potential (WOCBP): i.e., fertile, following menarche and until becoming post-menopausal, unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy.

3. Patients legally capable of giving their consent to participate in the study (including personal data processing) and available to sign and date the written informed consent.

E.4

Principal exclusion criteria

1. Known hypersensitivity to benzydamine or its excipients;
2. Phenylketonuria;
3. Clinically significant abnormalities at physical examination and vital signs;
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. Mouth breathing due to nasal congestion which causes throat drying;
8. Severe coughing which causes throat discomfort;
9. Purulent plaques on the tonsils;
10. Any inhaled therapy in the previous week before the first drug administration;
11. Use of antibiotics for an acute disease in the 7 days before randomisation (chronic antibiotic use, such as for acne, is acceptable); any sustained release analgesic within 24 hours of administration of study medication; any medications for cold and flu (i.e., decongestants, antihistamines, expectorants, antitussives), immediate release analgesic or antipyretic within 4 hours of administration of study medication;
12. Use of any lozenge, mouthwash, spray or menthol-containing products within 2 hours of administration of study medication;
13. Women during pregnancy or lactation period;
14. Subject involved in the conduct of the study (e.g. Investigator or his/her deputy, first grade relatives, pharmacist, assistant or other personnel, etc);
15. Participation to a clinical trial within 3 months prior to the inclusion in the study.

E.5 End points

E.5.1

Primary end point(s)

Primary endpoint: percentage of responders defined as patients reported at least a “slight relief” (STRRS score ≥1) at 2 minutes after the first application of benzydamine hydrochloride 0.3% spray or benzydamine hydrochloride 3mg lozenges.
The quantification of pain relief obtained will be assessed by completing the STRRS (Sore Throat Relief Rating Scale).
A “slight relief” in STRRS (score≥1) will be considered as the first perceived pain relief.

E.5.1.1

Timepoint(s) of evaluation of this end point

2 minutes

E.5.2

Secondary end point(s)

Secondary endpoints: the secondary endpoints of the study will be:

1) percentage of patients recording a first perceived pain relief assessed at T1 min. A “slight relief” in STRRS (score≥1) will be considered as the first perceived pain relief;
2) percentage of patients recording a meaningful sore throat relief assessed at T5 min, T10 min, T15 min, T30 min, T60 min and T120 minutes after a single dose administration. A “meaningful sore throat relief” is considered as a score ≥ 3 (moderate relief) in the STRRS;
3) the change from 1 minute up to 4 hours post-dose (T1 min; T2 min; T5min; T10min; T15min; T30min; T60min; T120min; T240min) in STRRS;
4) the change from baseline up to 2 hours post-dose (T0; T5 min; T10 min; T15 min; T30 min; T60 min; T120 min) in DSS (Difficulty Swallowing Scale) and the SwoTS (Swollen Throat Scale);
5) the change from baseline at T60 and 120 minutes post-dose in QuaSTI (Qualities of Sore Throat Index);
6) the change in sore throat pain intensity from baseline up to 7 days of treatment through the STPIS assessment (Sore Throat Pain Intensity Scale);
7) the treatment effect at the end of the treatment period through a TPA (Tonsillo-Pharyngitis Assessment);
8) the patient global treatment evaluation at the end of the treatment period through a PSQ (Patient Satisfaction Questionnaire);
9) safety assessment.

E.5.2.1

Timepoint(s) of evaluation of this end point

1) 1 minute
2) 120 minutes
3) 240 minutes
4) 120 minutes
5) 120 minutes
6) 7 days
7) 7 days
8) 7 days
9) 7 days

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

Yes

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

Yes

E.8.2.3.1

Comparator description

comparison of IMP spray and lozenges

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

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Russian Federation

Hungary

Poland

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

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)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

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

Yes

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

Information not present in EudraCT

F.4 Planned number of subjects to be included

F.4.1

In the member state

100

F.4.2

For a multinational trial

F.4.2.1

In the EEA

200

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)

None

G. Investigator Networks to be involved in the Trial

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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2020-02-25

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-01-23

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2021-06-30

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