Clinical Trials Register

Summary
EudraCT Number:	2012-001718-41
Sponsor's Protocol Code Number:	MK-0517-31-00
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2012-07-25
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

2012-001718-41

A.3

Full title of the trial

A Phase III, Randomized, Double-Blind, Active Comparator-Controlled Parallel-Group Study, Conducted Under In-House Blinding Conditions, to Examine the Efficacy and Safety of a Single 150 mg Dose of Intravenous Fosaprepitant Dimeglumine for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) Associated With Moderately Emetogenic Chemotherapy.

Studio di fase III, randomizzato, in doppio cieco, a gruppi paralleli controllato con comparatore attivo, condotto in condizioni di cieco interne, per esaminare l'efficacia e la sicurezza di una singola dose da 150 mg di fosaprepitant dimeglumina per via endovenosa per la prevenzione di nausea e vomito indotti da chemioterapia (CINV) associati a chemioterapia moderatamente emetogena.

A.3.1

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

Examine the Efficacy and Safety of a Single Dose of Intravenous MK-0517.

Studio per esaminare l'efficacia e la sicurezza di una singola dose da 150 mg di fosaprepitant dimeglumina per via endovenosa per la prevenzione di nausea e vomito indotti da chemioterapia associati a chemioterapia moderatamente emetogena.

A.3.2

Name or abbreviated title of the trial where available

Examine the Efficacy and Safety of a Single Dose of Intravenous MK-0517.

Fase III SD IV MEC.

A.4.1

Sponsor's protocol code number

MK-0517-31-00

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	Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
B.1.3.4	Country	United States
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	Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	MSD Italia S.r.l.
B.5.2	Functional name of contact point	Divisione Ricerca Clinica
B.5.3	Address:
B.5.3.1	Street Address	Via Fratelli Cervi, snc - Centro Direzionale Milano Due - Palazzo Borromini
B.5.3.2	Town/ city	Segrate (MI)
B.5.3.3	Post code	20090
B.5.3.4	Country	Italy
B.5.4	Telephone number	+39 02 21018402
B.5.5	Fax number	+39 02 21018629
B.5.6	E-mail	gcto.italy@merck.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	IVEMEND
D.2.1.1.2	Name of the Marketing Authorisation holder	Merck Sharp & Dohme Limited
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
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.3.4	Pharmaceutical form	Powder for solution for infusion
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	FOSAPREPITANT
D.3.9.1	CAS number	172673-20-0
D.3.9.2	Current sponsor code	MK-0517
D.3.9.4	EV Substance Code	SUB25384
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	150
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	ZOFRAN
D.2.1.1.2	Name of the Marketing Authorisation holder	Glaxo Wellcome UK Limited
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
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.3.4	Pharmaceutical form	Capsule
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ONDANSETRON
D.3.9.1	CAS number	116002-70-1
D.3.9.4	EV Substance Code	SUB09445MIG
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	8
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: 3
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	Dexamethasone
D.2.1.1.2	Name of the Marketing Authorisation holder	GALENpharma, Germany
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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.3.4	Pharmaceutical form	Capsule
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	DEXAMETHASONE
D.3.9.1	CAS number	50-02-2
D.3.9.4	EV Substance Code	SUB07017MIG
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	4
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: 4
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	Dexamethasone
D.2.1.1.2	Name of the Marketing Authorisation holder	GALENpharma, Germany
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	DEXAMETHASONE
D.3.9.1	CAS number	50-02-2
D.3.9.4	EV Substance Code	SUB07017MIG
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	4
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Capsule
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Chemotherapy induced nausea and vomiting.

Nausea e vomito associati a chemioterapia moderatamente emetogena.

E.1.1.1

Medical condition in easily understood language

Prevention of chemotherapy induced nausea and vomiting.

Prevenzione di nausea e vomito associati a chemioterapia moderatamente emetogena.

E.1.1.2

Therapeutic area

Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	PT
E.1.2	Classification code	10054133
E.1.2	Term	Prophylaxis of nausea and vomiting
E.1.2	System Organ Class	10042613 - Surgical and medical procedures

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 compare the single-dose fosaprepitant 150 mg regimen to the control regimen in terms of the proportion of patients with Complete Response (no vomiting and no use of rescue medication) from 25 to 120 hours (delayed phase) following initiation of moderately emetogenic chemotherapy (MEC).

Obiettivi: confrontare il regime di fosaprepitant in singola dose da 150 mg con il regime di controllo in termini di percentuale di pazienti con risposta completa (nessun episodio di vomito e nessun impiego di farmaci di soccorso) da 25 a 120 ore (fase ritardata) dopo l'inizio di chemioterapia moderatamente emetogena (MEC). Ipotesi: il regime di fosaprepitant in singola dose da 150 mg fornirà un controllo superiore di CINV rispetto al regime di controllo, come rilevato dalla percentuale dei pazienti con risposta completa nella fase ritardata. Obiettivo: valutare la sicurezza e la tollerabilità di fosaprepitant in singola dose da 150 mg in pazienti sottoposti a MEC. Ipotesi: il regime di fosaprepitant in singola dose da 150 mg è ben tollerato in pazienti sottoposti a MEC.

E.2.2

Secondary objectives of the trial

To compare the single-dose fosaprepitant 150 mg regimen and the control regimen in terms of the proportion of patients with a Complete Response (no vomiting and no use of rescue medication) in the overall phase (in the 120 hours following initiation of MEC).

Obiettivi: confrontare il regime di fosaprepitant in singola dose da 150 mg con il regime di controllo in termini di percentuale di pazienti con una risposta completa (nessun episodio di vomito e nessun impiego di farmaci di soccorso) nella fase complessiva (nelle 120 ore dopo l'inizio di MEC). Ipotesi: il regime di fosaprepitant in singola dose da 150 mg è superiore al regime di controllo in termini di percentuale di pazienti con una risposta completa nella fase complessiva (nelle 120 ore dopo l'inizio di MEC). Obiettivi: confrontare il regime di fosaprepitant in singola dose da 150 mg con il regime di controllo in termini di percentuale di pazienti con una risposta completa (nessun episodio di vomito e nessun impiego di farmaci di soccorso) nella fase acuta (da 0 a 24 ore dopo l'inizio di MEC). Ipotesi: il regime di fosaprepitant in singola dose da 150 mg è superiore al regime di cont

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Male or female ≥ 18 years • Confirmed malignant disease • Naïve to MEC and HEC • Scheduled to receive a single IV dose of one or more MEC agents except for the combination of anthracycline and cyclophosphamide (AC MEC) such as: Alemtuzumab Daunorubicin Azacitidine Doxorubicin Bendamustine Epirubicin Carboplatin Idarubicin Clofarabine Ifosfamide Cyclophosphamide(<1500mg/m2) Irinotecan Cytarabine (>1 g/m2) Oxaliplatin

1. deve essere di sesso femminile o maschile con età ≥ a 18 anni.
2. ha una neoplasia confermata da esame istologico o citologico.
3. accetta di partecipare allo studio dando il proprio consenso informato scritto.
4. è naïve a chemioterapia antitumorale da moderatamente ad altamente emetogena in base alla classificazione di Hesketh di agenti chemioterapici emetogeni.
5. è in attesa di ricevere una singola dose endovenosa di uno o più agenti chemioterapici moderatamente emetogeni il Giorno 1, fatta eccezione per la combinazione di antraciclina e ciclofosfamide (AC MEC).
6. L'aspettativa di vita prevista per il paziente corrisponde a ≥ 4 mesi.
7. ha un punteggio Karnofsky ≥ 60
8. I soggetti di sesso femminile potenzialmente fertili devono risultare negativi al test di gravidanza sulle urine svolto nell'ambito della visita pre-studio e accettare di astenersi da rapporti sessuali o utilizzare una forma contraccettiva di barriera per almeno 14 giorni prima, durante e per almeno 1 mese dopo la somministrazione dell'ultima dose di farmaco in studio.
9. Il paziente è in grado di leggere, capire e compilare il diario e il questionario dello studio.

E.4

Principal exclusion criteria

• Vomiting within 24 hours of treatment day 1 • Scheduled to receive AC,cisplatin, or other HEC agent • Allergic to aprepitant, fosaprepitant, ondansetron or dexamethasone • Taking systemic corticosteroids • Known history of QT prolongation • Patient has an active infection (e.g., pneumonia), any uncontrolled disease (e.g., diabetic ketoacidosis, congestive heart failure, bradyarrythmia's, pre-existing gastrointestinal conditions/gastrointestinal obstruction) except for malignancy, or a history of any illness, which, in the opinion of the investigator, might confound the results of the study or pose unwarranted risk in administering study drug/comparator to the patient.

1. ha subito un episodio di vomito nelle 24 ore precedenti il Giorno 1 di trattamento.
2. è affetto da neoplasia primaria sintomatica o metastatica sintomatica del SNC, causa di nausea e/o vomito.
3. è in attesa di ricevere la combinazione di antraciclina + ciclofosfamide o cisplatino o agente chemioterapico classificato come altamente emetogeno.
4. è stato sottoposto o sarà sottoposto a radioterapia all'addome o alla pelvi una settimana prima del Giorno 1 di trattamento fino al Giorno 6.
5. presenta un'infezione attiva, altra patologia non controllata, salvo per neoplasia o anamnesi di altre patologie che, a discrezione dello sperimentatore, potrebbero confondere i risultati dello studio o rappresentare per il paziente un rischio ingiustificato associato alla somministrazione del farmaco in studio/comparatore.
6. ha un'anamnesi pregressa di prolungamento del QT.
7. fa attualmente uso di droghe illecite, o evidenzia un attuale abuso di alcolici.
8. è mentalmente inabile o presenta un disturbo di natura emotiva o psichiatrica significativo che, a parere dello sperimentatore, preclude l'ammissione allo studio.
9. ha una storia di ipersensibilità ad aprepitant, ondansetron o desametasone.
10. è in stato di gravidanza o in allattamento.
11. ha partecipato a uno studio con aprepitant o ha assunto un farmaco non approvato nelle ultime 4 settimane.
12. assume attualmente warfarin o altri substrati di CYP2C9.
13-16 assume o ha assunto farmaci interagenti col CYP3A4 o antiemetici (Rif. Tabella 2-1 del protocollo),
17. ha assunto benzodazepine o oppiati.
18. presenta un disturbo concomitante, come infezione micotica sistemica o forme diabetiche incontrollate, che precluderebbe la somministrazione di desametasone.
19. assume una terapia corticosteroidea per via sistemica a una qualsiasi dose; sono consentiti corticosteroidi per uso topico e da inalare.
20. è positiva al test di gravidanza sul siero.
21. Valori di laboratorio anomali rispetto ai valori normali riportati nel protocollo.

E.5 End points

E.5.1

Primary end point(s)

superior control of CINV compared to the control regimen as measured by the proportion of patients with Complete Response in the delayed phase. Safety: The single-dose fosaprepitant 150 mg regimen is well tolerated in patients receiving MEC.

Percentuale di pazienti con risposta completa dopo 25 - 120 ore dall'inizio della somministrazione di MEC.

E.5.1.1

Timepoint(s) of evaluation of this end point

0 to 120 hours following initiation of chemotherapy.

da 25 a 120 ore dopo l'inizio di chemioterapia MEC.

E.5.2

Secondary end point(s)

The single-dose fosaprepitant 150 mg regimen is superior to the control regimen with respect to the proportion of patients with a Complete Response in the overall phase (0in the 120 hours following initiation of MEC).

Percentuale di pazienti con risposta completa dopo 0 - 24 ore dall'inizio della somministrazione di MEC.

E.5.2.1

Timepoint(s) of evaluation of this end point

0 to 120 hours following initiation of chemotherapy.

da 0 a 120 ore dopo l'inizio di chemioterapia MEC.

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

Yes

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

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

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

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

Argentina

Brazil

Canada

Chile

Colombia

India

Mexico

Peru

Philippines

Russian Federation

South Africa

Thailand

Turkey

Ukraine

United States

Venezuela, Bolivarian Republic of

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

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:

740

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

250

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

400

F.4.2.2

In the whole clinical trial

990

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)

n.a.

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

2012-09-14

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-07-19

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2014-11-03

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IMP with orphan designation in the indication
Orphan Designation Number:
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