Clinical Trials Register

Summary
EudraCT Number:	2020-003306-32
Sponsor's Protocol Code Number:	030(Z)WO19247
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:	2020-11-20
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

2020-003306-32

A.3

Full title of the trial

Phase IV study on the feasibility of a preventative/therapeutic approach with Benzydamine Oromucosal solution in radiation-induced Oral Mucositis (OM) in patients with head and neck cancer (HNC)

IV. fázisú vizsgálat benzidamin oromucosalis oldattal végzett prevenció/terápia megvalósíthatóságáról sugárkezelés indukálta oralis mucositis esetén a fej-nyak rosszindulatú daganatában szenvedő betegeknél

A.3.1

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

BOOM study (Benzydamine Oromucosal solution in Oral Mucositis)

A.3.2

Name or abbreviated title of the trial where available

BOOM study

A.4.1

Sponsor's protocol code number

030(Z)WO19247

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	Valerie Tellone
B.5.3	Address:
B.5.3.1	Street Address	Viale Amelia, 70,
B.5.3.2	Town/ city	Roma
B.5.3.3	Post code	00181 RM
B.5.3.4	Country	Italy
B.5.4	Telephone number	+393452493461
B.5.5	Fax number	+390691045 405
B.5.6	E-mail	valeria.tellone@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% w/v mouthwash
D.2.1.1.2	Name of the Marketing Authorisation holder	Aziende Chimiche Riunite Angelini Francesco – A.C.R.A.F. S.p.A.
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% w/v mouthwash
D.3.4	Pharmaceutical form	Mouthwash
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oromucosal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	benzydamine hydrochloride
D.3.9.1	CAS number	132-69-4
D.3.9.2	Current sponsor code	AF 864
D.3.9.3	Other descriptive name	BENZYDAMINE HYDROCHLORIDE
D.3.9.4	EV Substance Code	SUB00737MIG
D.3.10	Strength
D.3.10.1	Concentration unit	% (W/V) percent weight/volume
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0.15
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

Oral Mucositis (OM) in patients with head and neck cancer (HNC)

E.1.1.1

Medical condition in easily understood language

Oral Mucositis in patients with head and neck cancer (HNC)

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10056468
E.1.2	Term	Oral mucosal disorder
E.1.2	System Organ Class	100000004856

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To assess the effectiveness of benzydamine oromucosal solution (mouthwash) in the prevention/treatment of radiation-induced oral mucositis, in HNC patients, from first day of RT through end of RT/ETTV

E.2.2

Secondary objectives of the trial

• The compliance to benzydamine treatment, from first day of RT through end of RT/ETTV
• The severity of OM, from first day of RT through end of RT/ETTV
• The duration and time to onset of severe OM, from first day of RT through end of RT/ETTV
• The nutritional status, from first day of RT through end of RT/ETTV
• The oncology treatment compliance, from first day of RT through end of RT/ETTV
• The healthcare resources consumed, from first day of RT through end of RT/ETTV
• The QoL, from first day of RT through end of RT/ETTV
• The use of opioid analgesics for OM pain, from first day of RT through end of RT/ETTV
• The safety , from first day of RT through end of RT/ETTV

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Male and female patients of any ethnic origin ≥18 years of age.
2. Patients diagnosed with stage III or IV HNC (histologic or cytologic diagnosis), according to VIII AJCC staging system, who are candidate and are about to start RT, with or without concomitant CT, with curative intent, either with exclusive or postoperative intent.
3. Eastern Cooperative Oncology Group (ECOG) performance status with a score of 0, or 1, or 2.
4. Patients legally capable of giving their consent to participate in the study and available to sign and date the written informed consent and the Declaration of consent for the processing of personal data.
5. 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 end of the study, 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.

E.4

Principal exclusion criteria

1. Patients with reported allergy to benzydamine or another component of the formulation used.
2. Any contraindications listed in the local product’s Summary of Product Characteristics (SmPCs).
3. Patients with prior head and neck RT (in the previous 6 months), or patients who received a palliative treatment.
4. Patients with distant metastatic disease and/or severe cognitive impairment and/or clinically symptomatic brain metastases and/or patients with significant comorbid conditions.
5. Patients with mucositis due to other medical conditions (e.g., gastro-oesophageal reflux, autoimmune disease, etc.).
6. Patients who use other oromucosal products (over the counter or prescription) for the same disease.
7. Prescription of other rinses (anaesthetics like “magic mouthwashes” or others), except from sodium bicarbonate rinses.
8. Use of chlorhexidine, other anti-inflammatory mouthwashes solutions, misoprostol, granulocyte macrophage colony-stimulating factor (GM-CSF) and sucralfate gel.
9. Employment of antifungal or antibiotic drugs as prophylaxis for mucositis; any therapeutic use in case of overt clinical infections is allowed.
10. Patients treated with other therapies that can cause mucositis, except for the therapies for their primary condition.
11. Patients treated with any topical anti-inflammatory/analgesic products for the mucositis.
12. Any other product that can interfere with the evaluation of pain or inflammatory state, according to the Investigator’s assessment.

E.5 End points

E.5.1

Primary end point(s)

The number of responders, defined as the number of HNC patients with OM pain intensity <5 (NRS), expressed in percentage, at Visits from 0 to 7 /ETTV, will be considered as primary end-point.

E.5.1.1

Timepoint(s) of evaluation of this end point

Visits from 0 to 7/ETTV

E.5.2

Secondary end point(s)

• The number of compliant patients, expressed in percentage, at Visits from 0 to 7/ETTV
• The change in score in the WHO oral mucositis grading scale with respect to the baseline, expressed in percentage, at Visits from 0 to 7/ETTV
• The number of days of duration and time to onset of severe mucositis (grade 3 or 4 on the WHO), at Visits from 0 to 7/ETTV
• The percentage change in body weight between Visit 0 and Visit 7/ETTV; the need for nutritional support (i.e., need of a feeding tube): type of enteral support, i.e., partial or total and number of days of need, at Visits from 0 to 7/ETTV
• The number of days of duration of RT/CT administered, number of days of discontinuation, dose modifications, possible delays, at Visits from 0 to 7/ETTV
• The number of days of hospitalization whose main reason is mucositis or one of its complications, at Visits from 0 to 7/ETTV
• The change in QoL with respect to Visit 0, at all the visits up to Visit 7/ETTV
• The number and type of opioid analgesics used for OM pain, at Visits from 0 to 7/ETTV
• The changes from baseline in vital signs, physical examination and adverse events, at Visits from 0 to 7/ETTV

E.5.2.1

Timepoint(s) of evaluation of this end point

Visits from 0 to 7/ETTV

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

Yes

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

E.8.1.1

Randomised

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

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)

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

Last patient last visit

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 months

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

Yes

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

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

100

F.4.2.2

In the whole clinical trial

100

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)

Best standard of care at investigator's discretion

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

2021-01-18

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-12-22

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2022-09-05

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