Clinical Trials Register

Summary
EudraCT Number:	2017-002269-23
Sponsor's Protocol Code Number:	COLELF17
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:	2021-06-08
Trial 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

2017-002269-23

A.3

Full title of the trial

PHARMACOKINETICS OF COLISTIN IN THE ELF AND THE PLASMA OF MDR-GNB OR XDR- GNB VAP OR VAT OR HCAP OR HAP PATIENTS WHO ARE MECHANICALLY VENTILATED: A RANDOMIZED CONTROLLED TRIAL

STUDIO CONTROLLATO, RANDOMIZZATO SULLA FARMACOCINETICA DI COLISTINA NELL¿ELF E NEL PLASMA DI PAZIENTI AFFETTI DA VAP O VAT O HCAP O HAP SOSTENUTE DA GERMI GRAM NEGATIVI MULTI-ANTIBIOTICO RESISTENTI (MDR-GNB) O DA GERMI GRAM NEGATIVI ESTESAMENTE ANTIBIOTICO RESISTENTI (XDR-GNB) E SOTTOPOSTI A VENTILAZIONE MECCANICA

A.3.1

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

PHARMACOKINETICS OF COLISTIN IN MDR-GNB OR XDR- GNB PNEUMONIA OR TRACHEOBRONCHITIS PATIENTS WHO ARE MECHANICALLY VENTILATED: A RANDOMIZED CONTROLLED TRIAL

STUDIO CONTROLLATO, RANDOMIZZATO SULLA FARMACOCINETICA DI COLISTINA IN PAZIENTI AFFETTI DA POLMONITI E TRACHEOBRONCHITI SOSTENUTE DA GERMI GRAM NEGATIVI MULTI-ANTIBIOTICO RESISTENTI O DA GERMI GRAM NEGATIVI ESTESAMENTE ANTIBIOTICO RESISTENTI E SOTTOPOSTI A VENTILAZIONE MECCANICA

A.3.2

Name or abbreviated title of the trial where available

PHARMACOKINETICS OF COLISTIN IN THE ELF AND THE PLASMA OF MDR-GNB OR XDR- GNB PNEUMONIA PATIENTS WHO

FARMACOCINETICA DI COLISTINA NELL¿ELF E NEL PLASMA IN PAZIENTI AFFETTI DA POLMONITE DA MDR-GNB O XDR

A.4.1

Sponsor's protocol code number

COLELF17

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	AZIENDA OSPEDALIERA UNIVERSITARIA INTEGRATA VERONA
B.1.3.4	Country	Italy
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Azienda Ospedaliera Universitaria Integrata Verona
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	Azienda Ospedaliera Universitaria Integrata Verona
B.5.2	Functional name of contact point	Unit¿ Ricerca Clinica
B.5.3	Address:
B.5.3.1	Street Address	Piazzale Stefani, 1
B.5.3.2	Town/ city	Verona
B.5.3.3	Post code	37126
B.5.3.4	Country	Italy
B.5.4	Telephone number	0458127043
B.5.5	Fax number	0458122814
B.5.6	E-mail	supporto.noprofit@aovr.veneto.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	COLIMICINA - 1000000 U/4 ML POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE PER USO INTRAMUSCOLARE1 FLACONCINO POLVERE + 1 FIALA SOLVENTE 4 ML
D.2.1.1.2	Name of the Marketing Authorisation holder	UCB PHARMA 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	COLIMICINA
D.3.4	Pharmaceutical form	Powder and solvent for solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Inhalation use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	COLISTIMETATO SODICO
D.3.9.1	CAS number	1264-72-8
D.3.9.2	Current sponsor code	COLISTIMETATO SODICO
D.3.9.3	Other descriptive name	SODIUM COLISTIMETATE
D.3.10	Strength
D.3.10.1	Concentration unit	U/ml unit(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	250000
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	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	COLIMICINA - 1000000 U/4 ML POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE PER USO INTRAMUSCOLARE1 FLACONCINO POLVERE + 1 FIALA SOLVENTE 4 ML
D.2.1.1.2	Name of the Marketing Authorisation holder	UCB PHARMA 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	COLIMICINA
D.3.4	Pharmaceutical form	Powder and solvent for solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	COLISTIMETATO SODICO
D.3.9.1	CAS number	1264-72-8
D.3.9.2	Current sponsor code	COLISTIMETATO SODICO
D.3.9.3	Other descriptive name	SODIUM COLISTIMETATE
D.3.10	Strength
D.3.10.1	Concentration unit	IU/ml international unit(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	250000
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	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

ventilator associated pneumonia or ventilator associated tracheobronchitis or health-care associated pneumonia or hospital acquired pneumonia

polmonite associata a ventilazione o tracheobronchite associata a ventilazione o polmonite associata ad assistenza sanitaria o polmonite acquisita in ospedale

E.1.1.1

Medical condition in easily understood language

pneumonia

polmoniti

E.1.1.2

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	PT
E.1.2	Classification code	10044314
E.1.2	Term	Tracheobronchitis
E.1.2	System Organ Class	10021881 - Infections and infestations

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	10035701
E.1.2	Term	Pneumonia gram-negative bacterial NOS
E.1.2	System Organ Class	10021881 - Infections and infestations

E.1.2 Medical condition or disease under investigation

E.1.2	Version	22.0
E.1.2	Level	LLT
E.1.2	Classification code	10047263
E.1.2	Term	Ventilation pneumonitis
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

1. Description of colistin intra-pulmonary and plasma pharmacokinetics in patients with HCAP, HAP, VAP or VAT sustained by MDR-GNB or XDR-GNB and treated with colistimethate sodium administered either intravenously or by intravenous and aerosol route. 2. To describe the safety of treatment with colistimethate sodium administered exclusively by parenteral route compared to treatment with colistimethate sodium administered both by parenteral route and aerosol.

1. Descrizione della farmacocinetica intra-polmonare e plasmatica di colistina in pazienti affetti da HCAP, HAP, VAP o VAT sostenute da MDR-GNB o da XDR-GNB e trattati con colistimetato sodico somministrato alle dosi attualmente indicate o esclusivamente per via endovenosa o sia per via endovenosa che per via aerosolica. 2. Descrivere la safety del trattamento con colistimetato sodico somministrato esclusivamente per via parenterale rispetto al trattamento con colistimetato sodico somministrato sia per via parenterale che aerosol.

E.2.2

Secondary objectives of the trial

1. To describe the microbiological success in patients treated with colistimetate sodium exclusively intravenously and in those treated with colistimetate sodium both intravenously and aerosol. 2. To describe the clinical success (improvement of respiratory exchanges and / or radiographic images and / or laboratory parameters and / or thermal curve) of patients treated with colistimethate sodium exclusively by parenteral route and in those treated with colistimethate sodium parenterally and aerosol. 3. To describe the mortality of patients enrolled in the two arms of the study at the end-of-treatment (EOT), that is after a maximum of 14 days of therapy, and 14 days after EOT

1. Descrivere il successo microbiologico nei pazienti trattati con colistimetato sodico esclusivamente per via endovenosa e in quelli trattati con colistimetato sodico sia per via endovenosa che aerosol. 2. Descrivere il successo clinico (miglioramento degli scambi respiratori e/o delle immagini radiografiche e/o dei parametri di laboratorio e/o della curva termica) dei pazienti trattati con colistimetato sodico esclusivamente per via parenterale e in quelli trattati con colistimetato sodico per via parenterale e aerosol. 3. Descrivere la mortalit¿ dei pazienti arruolati nei due bracci dello studio all¿end of treatment (EOT), ovvero dopo un massimo di 14 giorni di terapia, e dopo 14 giorni dall¿EOT.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- inpatients at U.O. of Anesthesia and Reanimation B - AOUI Verona
- age> 18 years
- both sexes;
- both women of childbearing age who taking contraceptives and who do not use them
- patients affected by HAP / HCAP / VAP / VAT
- patients subjected to invasive ventilation
- isolation from deep respiratory secretions of A.baumannii and / or P. aeruginosa sensitive to no more than two classes of antibiotics, one of which is represented by polymyxins (XDR) and / or Enterobacteriaceae resistant to carbapenems and sensitive to polymyxins (MDR or XDR), according to the following quantitative parameters:
- BAL (broncho-alveolar lavage):> 104 CFU / mL in the course of HAP / HCAP / VAP
- BAS (broncoaspirate):> 106 CFU / mL in the course of HAP / HCAP / VAP / VAT;
> 105 CFU / mL in the course of VAT
or patient known to be colonized intestinally (rectal surveillance buffer) or pharyngeal (surveillance pharyngeal swab) from the above-mentioned bacterial agents and waiting for the outcome of the BAL / BAL culture tests
N.B: all the microbiological tests must not have been performed more than one week before enrollment
- written informed consent by the patient (if the patient is unable to provide it at the beginning of the study, it will be obtained as soon as possible). If the patient is unable to provide consent, a legal representative of the subject is required to sign it.

- pazienti degenti presso U.O. di Anestesia e Rianimazione B dell’Azienda Ospedaliera Universitaria Integrata di Verona
- età > 18 anni
- entrambi i sessi; per quanto riguarda le donne in età fertile, potranno essere arruolate sia donne che assumono contraccettivi che donne che non ne fanno uso
- affetti da HAP/HCAP/ VAP/VAT
- sottoposti a ventilazione invasiva
- isolamento da secrezioni respiratorie profonde di A.baumannii e/o P.aeruginosa sensibili a non più di due classi antibiotiche di cui una rappresentata dalle polimixine (XDR) e/o di Enterobacteriaceae resistenti ai carbapenemici e sensibili alle polimixine (MDR o XDR), secondo i seguenti parametri quantitativi:
BAL (lavaggio bronco-alveolare): > 104 CFU/mL in corso di HAP/HCAP/VAP
BAS (broncoaspirato): > 106 CFU/mL in corso di HAP/HCAP/VAP/VAT
> 105 CFU/mL in corso di VAT
o paziente noto per essere colonizzato a livello intestinale (tampone rettale di sorveglianza) o faringeo (tampone faringeo di sorveglianza) dagli agenti batterici sopracitati e in attesa dell’esito degli esami colturali del BAL/BAL
N.B: tutti gli accertamenti microbiologici non devono essere stati eseguiti più di una settimana prima dall’arruolamento
- consenso informato scritto da parte del paziente o, se incapace di fornirlo, ottenuto non appena in grado di farlo. Se il paziente fosse impossibilitato a fornire il consenso è prevista la firma da parte di un legale rappresentante del soggetto

E.4

Principal exclusion criteria

- Pregnancy and breastfeeding
- Intermittent dialysis or CRRT (continuous renal replacement therapy)
- Concomitant enlistment in other research protocols
- Known intolerance to colistimethate sodium and / or to any of the excipients
- Use of intravenous colistimetate sodium and / or aerosol 7 days prior to enrollment
- Personal history or family history of myasthenia

- Gravidanza e allattamento
- Dialisi intermittente o CRRT (continuous renal replacement therapy)
- Concomitante arruolamento in altri protocolli di ricerca
- Intolleranza nota al colistimetato sodico e/o ad uno qualsiasi degli eccipienti
- Utilizzo di colistimetato sodico per via endovenosa e/o per via aerosolica nei 7 giorni precedenti l’arruolamento
- Storia personale o familiare di miastenia

E.5 End points

E.5.1

Primary end point(s)

Pharmacokinetic parameters obtained by measuring the colistin intrapulmonary and plasma concentration: AUC, Cmax, Tmax, T1 / 2, Volume of distribution and Clearance. 2. Description of the safety of the treatment, evaluating the appearance of any adverse event (AE), adverse reaction (ADR), serious adverse event (SAE) about: - renal function (plasma creatinine, creatinine clearance in 24 h) - the appearance of hypersensitivity reactions such as rash and angioedema; - the appearance of psychiatric disorders such as confusion, psychosis; - the appearance of neurotoxic effects such as paresthesia, dizziness, tingling at the extremities and the tongue, language disorder and imbalance of the autonomic nervous system, neuromuscular block to apnea. - the appearance, in patients treated also with sodium colistimetate by aerosol, of bronchospasm

1. Parametri farmacocinetici di colistina ottenuti sia attraverso la misurazione della concentrazione intrapolmonare che plasmatica: AUC, Cmax, Tmax, T1/2, Volume di distribuzione e Clearance.
2. Descrizione della safety del trattamento, valutando la comparsa di qualsiasi evento avverso (AE), reazione avversa (ADR), evento avverso serio (SAE) attraverso il monitoraggio a 48h, a 5 giorni, dopo 7-10 giorni e alla fine del trattamento:
o della funzionalità renale (creatinina plasmatica, clearance della creatinina nelle 24 h) dei pazienti trattati con colistimetato sodico esclusivamente per via parenterale e in quelli trattati con colistimetato sodico anche per via aerosol; della comparsa di reazioni di ipersensibilità come l’eruzione cutanea e l’angioedema;
o della comparsa, nei pazienti di entrambi i bracci di studio, di disturbi psichiatrici come confusione, psicosi;
o della comparsa, nei pazienti di entrambi i bracci di studio, di effetti neurotossici come parestesia, capogiro, formicolio alle estremità ed alla lingua, disturbo del linguaggio e squilibrio del sistema nervoso autonomo, blocco neuromuscolare fino all’apnea.
o della comparsa, nei pazienti trattati anche con colistimetato sodico per via aerosolica, di broncospamo

E.5.1.1

Timepoint(s) of evaluation of this end point

1. Pharmacokinetic in plasma: time: 0, 0.5, 1, 2, 4, 8, 12 h since the beginning of colistimethate sodium loading dose and at the same time intervals from the beginning of the 5th dose administration (steady state) Pharmacokinetics in the ELF: GROUP A: after 2 h from the beginning of the loading dose infusion of colistimethate sodium and after 2 h from the beginning of the 5th dose infusion (steady state). GROUP B: after 4 h from the beginning of the loading dose infusion of colistimethate sodium and after 4 h from the beginning of the 5th dose infusion (steady state) GROUP C: after 8 h from the beginning of the loading dose infusion of colistimethate sodium and after 8 h from the beginning of the 5th dose infusion (steady state) 2. at 48h, at 5 days, after 7-10 days and at the end of trea

1. farmacocinetica nel plasma: a tempo zero, 0.5, 1, 2, 4, 8, 12 h dall’inizio dell’infusione della dose da carico di colistimetato sodico e ai medesimi intervalli di tempo dall’inizio della somministrazione della 5^ dose (steady state) farmacocinetica nell’ELF: GRUPPO A: dopo 2 h dall’inizio dell’infusione della dose da carico di colistimetato sodico e dopo 2 h dall’inizio dell’infusione della 5^ dose (steady state). GRUPPO B: dopo 4 h dall’inizio dell’infusione della dose da carico di colistimetato sodico e dopo 4 h dall’inizio dell’infusione della 5^ dose (steady state) GRUPPO C: dopo 8 h dall’inizio dell’infusione della dose da carico di colistimetato sodico e dopo 8 h dall’inizio dell’infusione della 5^ dose (steady state) 2. 48h, a 5 giorni, dopo 7-10 giorni e alla fine del trattamen

E.5.2

Secondary end point(s)

- 7-10 giorni dall¿inizio della terapia
- 48 h dall¿inizio della terapia ; Description of clinical success, as improvement of respiratory exchanges (pCO2, pO2, pO2 / FiO2) and / or radiographic images (chest X-ray and / or chest CT) and / or laboratory parameters (blood count with formula, PCR, PCT) and / or and of the thermal curve of patients enrolled in both arms of the study, by clinical / bio-humoral and instrumental assessment ; all¿EOT e dopo 14 giorni dall¿EOT

Descrizione, in entrambi i bracci di studio, della risposta microbiologica favorevole, intesa come:
- negativizzazione/riduzione della carica batterica nel BAL dei germi isolati all¿esordio, mediante l¿esecuzione di una TBS di controllo a 7-10 giorni dall¿inizio della terapia;
- negativizzazione delle emocolture a 48 h dall¿inizio della terapia nei pazienti in cui sono risultate positive al momento dell¿arruolamento ; Descrizione del successo clinico inteso come miglioramento degli scambi respiratori (pCO2, pO2, pO2/FiO2) e/o delle immagini radiografiche (Rx torace e/o TAC torace) e/o dei parametri di laboratorio (emocromo con formula, PCR, PCT) e/o e della curva termica dei pazienti arruolati in entrambi i bracci dello studio, mediante valutazione clinica/bio-umorale e strumentale; Descrizione della mortalit¿ dei pazienti arruolati nei due bracci dello studio

E.5.2.1

Timepoint(s) of evaluation of this end point

- 7-10 days from the start of therapy
- 48 h from the start of therapy; during treatment, at the end of treatment (EOT) and after 14 days from EOT; at EOT and 14 days after EOT

Description, in both the study arms, of the favorable microbiological response, understood as:
- negativization / reduction of the bacterial charge of the germs isolated at the onset of inflammation in the BAL, by performing a control TBS at 7-10 days from the start of therapy;
- negativization of blood cultures at 48 h from the start of therapy in patients who were positive at the time of enrollment; durante il trattamento, all¿end of treatment (EOT) e dopo 14 giorni dall¿EOT; Description of mortality of patients enrolled in the two arms of the study

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

Yes

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)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

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)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Stesso farmaco somministrato per via di somministrazione diversa da quella registrata

Same drug given through different route of administration

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.1.1.1

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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2021-06-08.

Yes

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

Yes

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)

according to good clinical practice

secondo buona pratica clinica

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

2018-05-22

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-01-24

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2022-07-02

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Orphan Designation Number:
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