Clinical Trials Register

Summary
EudraCT Number:	2016-001598-33
Sponsor's Protocol Code Number:	PSC-DS-BRETEX
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2018-01-18
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

Italy - Italian Medicines Agency

A.2

EudraCT number

2016-001598-33

A.3

Full title of the trial

Comparison of two methods for in vivo diagnosis of Helicobacter pylori infection, by means of a tablet of 13C-Urea.

Confronto di due metodiche per la diagnosi in vivo dell’infezione da Helicobacter pylori, mediante utilizzo di una compressa di 13C-urea

A.3.1

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

Comparison of two methods for in vivo diagnosis of Helicobacter pylori infection, by means of a tablet of 13C-Urea.

Confronto di due metodiche per la diagnosi in vivo dell’infezione da Helicobacter pylori, mediante utilizzo di una compressa di 13C-urea

A.3.2

Name or abbreviated title of the trial where available

Comparison of two methods for in vivo diagnosis of Helicobacter pylori infection, by means of a tabl

Confronto di due metodiche per la diagnosi in vivo dell’infezione da Helicobacter pylori, mediante u

A.4.1

Sponsor's protocol code number

PSC-DS-BRETEX

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	SOFAR 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	SOFAR 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	SOFAR S.p.A.
B.5.2	Functional name of contact point	Divisione Medica
B.5.3	Address:
B.5.3.1	Street Address	Via Firenze, 40
B.5.3.2	Town/ city	Trezzano Rosa (MI)
B.5.3.3	Post code	20060
B.5.3.4	Country	Italy
B.5.4	Telephone number	+39 029093621
B.5.5	Fax number	+39 02909362915
B.5.6	E-mail	laura.patrucco@sofarfarm.it

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	EXPIROBACTER - 100 MG COMPRESSA SOLUBILE 1 COMPRESSA
D.2.1.1.2	Name of the Marketing Authorisation holder	SOFAR 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	EXPIROBACTER 100 mg compressa solubile
D.3.4	Pharmaceutical form	Soluble tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	UREA 13 C
D.3.9.1	CAS number	58069-82-2
D.3.9.2	Current sponsor code	UREA 13 C
D.3.9.3	Other descriptive name	UREA 13 C
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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	Yes
D.3.11.13.1	Other medicinal product type	Diagnostico
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	EXPIROBACTER - 100 MG COMPRESSA SOLUBILE 1 COMPRESSA
D.2.1.1.2	Name of the Marketing Authorisation holder	SOFAR 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	EXPIROBACTER 100mg compressa solubile
D.3.4	Pharmaceutical form	Soluble tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	UREA 13 C
D.3.9.1	CAS number	58069-82-2
D.3.9.2	Current sponsor code	UREA 13 C
D.3.9.3	Other descriptive name	UREA 13 C
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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	Yes
D.3.11.13.1	Other medicinal product type	Diagnostico

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

H. pylori infection

Infezione da Helicobacter pylori

E.1.1.1

Medical condition in easily understood language

H. pylori infection

Infezione da Helicobacter pylori

E.1.1.2

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.1
E.1.2	Level	LLT
E.1.2	Classification code	10019377
E.1.2	Term	Helicobacter pylori infection
E.1.2	System Organ Class	100000004862

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Concordance between the results obtained with the two methods

Concordanza del risultato tra le due metodiche

E.2.2

Secondary objectives of the trial

Level of patient’s satisfaction obtained with a value subjective scale, about the molecular correlation spectrometry method (Breath ID®) and the infrared spectrometry.

Grado di soddisfazione del paziente tramite una scala a valori soggettiva, riguardo alla metodica a spettrometria a correlazione molecolare (Breath ID®) e alla spettrometria a infrarossi.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Both sexes.
2. Age ≥ 18 years old
3. Outpatients, for whom urea breath test for H. pylori infection is indicated.
4. Written informed consent.

1. Pazienti ambosessi.
2. Età ≥18 anni.
3. Pazienti per i quali sia indicata l’esecuzione di un test diagnostico per la determinazione dell’infezione da H. pylori.
4. Consenso espresso in forma scritta.

E.4

Principal exclusion criteria

1. Therapy with antibiotics or bismuth in the 4 weeks before the enrollment;
2. Therapy with inhibitors of the proton pump in the 2 weeks before the enrollment;
3. Presence of alarm symptoms (e.g. unintentional weight loss, sideropenic anemia, gastrointestinal bleeding, dysphagia);
4. Atrophic gastritis;
5. Gastro-enteric tract neoplasia;
6. Known or suspected hypersensitivity to one or more components of EXPIROBACTER®;
7. Pregnancy or lactation;
8. Recent or suspected alcohol or drug abuse;
9. Presence of any kind of dementia or other possible causes of a progressive deterioration of the full possession of one's faculties or a psycho-physic inability that decreases the ability to take correctly the prescribed treatment;
10. Not sufficiently reliable or presence of conditions that may result in non-compliance/adherence of the patient to the protocol;
11. Concomitant involvement in another clinical trial;
12. Minor patients;
13. Patients who are unable to carry out study procedures or who have not given their written consent.

1. Terapia con antibiotici o bismuto nelle 4 settimane precedenti all’arruolamento;
2. Terapia con inibitori di pompa protonica nelle 2 settimane precedenti all’arruolamento;
3. Presenza di sintomi d’allarme (es. perdita di peso non intenzionale, anemia sideropenica, sanguinamento gastrointestinale, disfagia);
4. Gastrite atrofica;
5. Neoplasie dell’apparato gastroenterico;
6. Allergia nota o sospetta ad uno o più componenti di EXPIROBACTER®;
7. Gravidanza o allattamento;
8. Recente storia o sospetto di abuso di alcol o di stupefacenti;
9. Presenza di una demenza di qualsiasi tipo o altre possibili cause di deterioramento progressivo della capacità di intendere e di volere o un’inabilità psico-fisica che riduca la capacità di assumere come previsto la terapia prescritta;
10. Non adeguata affidabilità o presenza di condizioni che possano determinare una non conformità/aderenza del paziente al protocollo;
11. Partecipazione ad un altro studio clinico concomitante;
12. Pazienti minorenni;
13. Pazienti che non siano in grado di seguire le procedure di studio o che non abbiano fornito il proprio consenso in forma scritta.

E.5 End points

E.5.1

Primary end point(s)

Concordance of the results given with the molecular correlation spectrometry method (Breath ID®) and with the infrared spectrometry, for the diagnosis of H. pylori infection

Sovrapponibilità dei risultati della ricerca di H. pylori ottenuti con la metodica a spettrometria a correlazione molecolare (Breath ID®) e con la spettrometria a infrarossi

E.5.1.1

Timepoint(s) of evaluation of this end point

Day 1

Giorno 1

E.5.2

Secondary end point(s)

Level of patient’s satisfaction obtained with a value subjective scale, about the molecular correlation spectrometry method (Breath ID®) and the infrared spectrometry.
Safety:
Adverse events will be recorded during the whole duration of the trial.

Grado di soddisfazione del paziente tramite una scala a valori soggettiva, riguardo alla metodica a spettrometria a correlazione molecolare (Breath ID®) e alla spettrometria a infrarossi.
Valutazioni di sicurezza:
Saranno registrati, per tutta la durata dello studio, gli eventi avversi.

E.5.2.1

Timepoint(s) of evaluation of this end point

Day 1

Giorno 1

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

Yes

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

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)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

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

Yes

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

Yes

E.8.2.3.1

Comparator description

Stesso farmaco e dosaggio utilizzato con metodiche ≠ per la determinaz. dell’infezione da H.pylori

Same drug and same dosage used in two different methods for diagnosis of Helicobacter pylori.

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

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

Information not present in EudraCT

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

Number of subjects for this age range:

F.1.1.1

In Utero

Information not present in EudraCT

F.1.1.2

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

Information not present in EudraCT

F.1.1.3

Newborns (0-27 days)

Information not present in EudraCT

F.1.1.4

Infants and toddlers (28 days-23 months)

Information not present in EudraCT

F.1.1.5

Children (2-11years)

Information not present in EudraCT

F.1.1.6

Adolescents (12-17 years)

Information not present in EudraCT

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

F.4.2.2

In the whole clinical trial

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

Nessuno

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

2016-07-27

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-05-17

P. End of Trial
P.	End of Trial Status	Prematurely Ended

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Orphan Designation Number:
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