Clinical Trials Register

Summary
EudraCT Number:	2016-002138-63
Sponsor's Protocol Code Number:	044-SI
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:	2018-02-07
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

2016-002138-63

A.3

Full title of the trial

A prospective, multi-center, controlled, double-blind study to evaluate the efficacy and tolerability of a steroid/antibiotic associated treatment following cataract extraction by means of phaco-emulsification.

Studio multicentrico, prospettico, controllato, in doppio cieco per valutare l’efficacia e la tollerabilità di un trattamento associato steroide/antibiotico a seguito dell’estrazione della cataratta tramite facoemulsificazione.

A.3.1

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

Clinical study to evaluate the efficacy and tolerability of a anti-inflammatory/antibiotic treatment following ocular cataract extraction.

Studio clinico per valutare l’efficacia e la tollerabilità di un trattamento antinfiammatorio/antibiotico a seguito dell’estrazione della cataratta oculare.

A.3.2

Name or abbreviated title of the trial where available

Low-dosage Netildex ophthalmic gel study

Studio su Netildex gel oftalmico a dosaggio ridotto

A.4.1

Sponsor's protocol code number

044-SI

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	SOCIETÀ INDUSTRIA FARMACEUTICA ITALIANA (SIFI) SPA
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	S.I.F.I. 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	S.I.F.I. S.p.A.
B.5.2	Functional name of contact point	Servizio Informazione sulla Sperime
B.5.3	Address:
B.5.3.1	Street Address	Via Ercole Patti, 36
B.5.3.2	Town/ city	Aci Sant'Antonio
B.5.3.3	Post code	95025
B.5.3.4	Country	Italy
B.5.4	Telephone number	+39-0957922201
B.5.5	Fax number	+39-0957922224
B.5.6	E-mail	info@sifigroup.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	NETILDEX - 1 MG/ML /3 MG/ML GEL OFTALMICO 10 CONTENITORI MONODOSE DA 0.4 ML
D.2.1.1.2	Name of the Marketing Authorisation holder	S.I.F.I. 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	NETILDEX™ 3mg/ml / 1mg/ml gel oftalmico
D.3.4	Pharmaceutical form	Eye gel
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	NETILMICINA SOLFATO
D.3.9.1	CAS number	56391-57-2
D.3.9.2	Current sponsor code	NETILMICINA SOLFATO
D.3.9.4	EV Substance Code	SUB03415MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	3
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	DESAMETASONE FOSFATO DISODICO
D.3.9.1	CAS number	55203-24-2
D.3.9.2	Current sponsor code	DESAMETASONE FOSFATO DISODICO
D.3.9.4	EV Substance Code	SUB122698
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	1
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	NETILDEX - 1MG/ML+3MG/ML COLLIRIO, SOLUZIONE - 15 CONTENITORI MONODOSE DA 0.3ML
D.2.1.1.2	Name of the Marketing Authorisation holder	S.I.F.I. 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	NETILDEX™ 3mg/ml / 1mg/ml collirio soluzione
D.3.4	Pharmaceutical form
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	NETILMICINA SOLFATO
D.3.9.1	CAS number	56391-57-2
D.3.9.2	Current sponsor code	NETILMICINA SOLFATO
D.3.9.4	EV Substance Code	SUB03415MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	3
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	DESAMETASONE FOSFATO DISODICO
D.3.9.1	CAS number	55203-24-2
D.3.9.2	Current sponsor code	DESAMETASONE FOSFATO DISODICO
D.3.9.4	EV Substance Code	SUB122698
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	1
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Eye gel

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Post-surgery ocular inflammation and infection after cataract extraction by means of phaco-emulsification and intra-ocular lens implantation.

Infiammazione oculare post-operatoria ed infezioni oculari post-chirurgiche dopo estrazione della cataratta tramite facoemulsificazione ed impianto di lente intraoculare.

E.1.1.1

Medical condition in easily understood language

Post-operative ocular inflammation and infection after cataract extraction.

Infiammazione oculare post-operatoria ed infezioni oculari post-chirurgiche dopo estrazione della cataratta.

E.1.1.2

Therapeutic area

Diseases [C] - Eye Diseases [C11]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	PT
E.1.2	Classification code	10063797
E.1.2	Term	Cataract operation
E.1.2	System Organ Class	10042613 - Surgical and medical procedures

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	PT
E.1.2	Classification code	10007739
E.1.2	Term	Cataract
E.1.2	System Organ Class	10015919 - Eye disorders

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 demonstrate the efficacy and tolerability of a reduced frequency of administration of NETILDEX ™ 3mg/ml / 1mg/ml ophthalmic gel, administered twice daily (b.i.d.), in comparison with NETILDEX ™ 3mg/ml / 1mg/ml eye drops solution, administered four times a day (q.i.d.), in the prevention of post-surgery ocular inflammation and infection after cataract extraction by means of phaco-emulsification and intra-ocular lens implantation.

Dimostrare l’efficacia e la tollerabilità di una ridotta frequenza di somministrazione (due volte al giorno, b.i.d.) di NETILDEX™ 3mg/ml / 1mg/ml gel oftalmico in confronto con NETILDEX™ 3mg/ml / 1mg/ml collirio soluzione, somministrato quattro volte al giorno (q.i.d.), nella prevenzione dell’infiammazione oculare post-operatoria e di infezioni post-chirurgiche dopo estrazione della cataratta tramite facoemulsificazione ed impianto di lente intraoculare.

E.2.2

Secondary objectives of the trial

a) to confirm the antibiotic efficacy of NETILDEX™ ophthalmic gel 24 hours after cataract surgery; b) to confirm the safety of NETILDEX™ ophthalmic gel in terms of intra-ocular pressure, adverse events, presence or absence of conjunctival hyperemia in Patients treated; c) to confirm the global tolerability of NETILDEX™ ophthalmic gel in Patients treated.

a) confermare l'efficacia antibiotica di NETILDEX™ gel oftalmico 24 ore dopo l'operazione di estrazione della cataratta; b) confermare la sicurezza di NETILDEX™ gel oftalmico in termini di pressione intra-oculare, eventi avversi, presenza o assenza di iperemia congiuntivale nei pazienti trattati; c) confermare la tollerabilitá globale di NETILDEX™ gel oftalmico nei pazienti trattati.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Male or female Patients
2. Patients aged ≥ 40 years old
3. Patients undergoing cataract extraction surgery through phaco-emulsification and intra-ocular lens implantation
4. Patients with grade 2 or 3 according to LOCS III system for grading age-related cataract
5. Patients with transparent cornea (endothelial count in the limits for age but not lower than 1200 cells/mm2)
6. Patients understanding the nature of the study and providing their informed consent to participation
7. Patients willing and able to attend the visits and procedures foreseen by study protocol
8. Patients with negative Amsler Test at enrolment visit (V1)

1. Pazienti di sesso maschile o femminile
2. Pazienti di età ≥ 40 anni
3. Pazienti sottoposti ad intervento di estrazione della cataratta tramite facoemulsificazione ed impianto di lente intraoculare
4. Pazienti con grado 2 o 3 secondo il sistema LOCS III per la classificazione della cataratta legata all’età
5. Pazienti con cornea trasparente (conta endoteliale nei limiti di età e comunque non minore di 1200 cellule/mm2)
6. Pazienti che comprendono appieno la natura dello Studio e che danno il loro consenso a parteciparvi
7. Pazienti disposti ed in grado di partecipare alle visite ed alle procedure previste dal protocollo di Studio
8. Pazienti con test di Amsler negativo al momento dell’arruolamento nello Studio (V1)

E.4

Principal exclusion criteria

1. Patients with medical history of ocular inflammation diseases, Herpes infections, iritis, uveitis or Sjogren's syndrome
2. Patients who have been treated for external ocular infections within a month before the study enrolment (V1)
3. Patients with cellularity in the anterior ocular chamber ≥ grade 2 (16-25 cells / field 1x1 mm)
4. Patients with flare in the anterior ocular chamber ≥ grade 2 (moderate)
5. Patients with at least one of the following concomitant ocular diseases: ocular infections, uveitis, iritis, iridociclitis, glaucoma, diabetic retinopathy, diabetes, maculopathy, shallow anterior chamber (based on Investigator’s judgment)
6. Patients with PEX Syndrome (Pseudo-exfoliation syndrome)
7. Patients with poor mydriasis, basing on Investigator’s judgment
8. Patients with intra-ocular pressure > 24 mmHg
9. Patients who have undergone surgery in the eye involved in the cataract extraction within the 12 months before the study enrolment (V1)
10. Patients who have received corneal laser treatment in the eye involved in the cataract extraction within the 6 months before the study enrolment (V1)
11. Patients with known or suspected allergy or hypersensitivity to ophthalmic preservatives, phenylacetic acid derivatives, aminoglycosides, Bromfenac, other NSAIDs, steroids
12. Patients with traumatic cataract condition
13. Patients who have been treated or are under treatment with alpha-blocking agents for more than 3 months before the study enrolment (V1)
14. Patients who have received treatment with anti-histamines, decongestants, anti-inflammatory steroidal or non-steroidal (NSAID) drugs within the 15 days before the study enrolment (V1)
15. Patients who are participating or have participated in other clinical studies within the 30 days before the study enrolment (V1)
16. Patients receiving any ocular treatment, with the exception of artificial tears
17. Female Patients who are pregnant or breast-feeding
18. Female Patients of childbearing age (less than 24 months after the last menstrual cycle) who do not use adequate contraception *
19. Monocle Patients
20. Patients with epiretinal membrane as per OCT test at enrolment visit (V1)

* Methods at low risk of contraceptive failure (less than 1% per year) when used consistently, including: implants, injectables, some intra-uterine devices, condoms, abstinence or vasectomized partner.

1. Pazienti con anamnesi di malattie infiammatorie oculari, infezioni da Herpes, irite, uveite o sindrome di Sjogren
2. Pazienti che sono stati trattati per infezioni oculari esterne nel mese antecedente l’arruolamento nello Studio (V1)
3. Pazienti con cellularità nella camera oculare anteriore di grado ≥ 2 (16-25 cellule / campo 1x1 mm)
4. Pazienti con flare nella camera oculare anteriore di grado ≥ 2 (moderato)
5. Pazienti con almeno una delle seguenti malattie oculari concomitanti: infezioni oculari, uveite, irite, iridociclite, glaucoma, retinopatia diabetica, diabete, maculopatia, camera anteriore poco profonda (basandosi sul giudizio dello Sperimentatore)
6. Pazienti affetti dalla sindrome PEX (Sindrome Pseudo-esfoliativa)
7. Pazienti con scarsa midriasi, basandosi sul giudizio dello Sperimentatore
8. Pazienti con pressione intraoculare > 24 mmHg
9. Pazienti che hanno subito un intervento chirurgico a livello dell’ occhio coinvolto nell’estrazione della cataratta nei 12 mesi antecedenti all' arruolamento nello Studio (V1)
10. Pazienti che hanno ricevuto un trattamento laser a livello della cornea dell’occhio coinvolto nell’estrazione della cataratta nei 6 mesi antecedenti all’arruolamento nello Studio (V1)
11. Pazienti con nota o sospetta allergia / ipersensibilità a conservanti oftalmici, derivati dell'acido fenilacetico, aminoglicosidi, Bromfenac, altri FANS, steroidi
12. Pazienti che soffrono di condizioni traumatiche della cataratta
13. Pazienti che hanno ricevuto un trattamento o stanno ricevendo un trattamento con agenti alfa-bloccanti per piú di 3 mesi prima dell' arruolamento nello Studio (V1)
14. Pazienti che hanno ricevuto un trattamento con antistaminici, decongestionanti, anti-infiammatori steroidei o non steroidei (FANS) nei 15 giorni antecedenti all’arruolamento nello Studio (V1)
15. Pazienti che stanno partecipando o hanno partecipato ad altri studi clinici nei 30 giorni antecedenti all’arruolamento nello Studio(V1)
16. Pazienti sottoposti a qualsiasi trattamento oculare ad eccezione dell’utilizzo di lacrime artificiali
17. Pazienti in gravidanza o allattamento
18. Pazienti di sesso femminile in età fertile (meno di 24 mesi dall’ultimo ciclo mestruale) che non fanno uso di contraccezione adeguata*

19. Pazienti monocoli
20. Pazienti che soffrono di membrana epiretinica, evidenziata da esame OCT al momento dell’arruolamento nello Studio (V1)

* Metodi a basso rischio di fallimento del contraccettivo (meno dell'1% l'anno), se usati in modo corretto, tra cui: impianti, iniettabili, alcuni dispositivi intrauterini, preservativi, astinenza o partner vasectomizzato.

E.5 End points

E.5.1

Primary end point(s)

Measurement of inflammation conditions in the anterior ocular chamber after cataract extraction through Slit Lamp and Bio-microscopy, according to a standard evaluation scheme based on cellularity in the anterior ocular chamber and on flare in the anterior ocular chamber (ref. [Merkoudis - Comparison of peroperative subconjunctival injection of methylprednisolone and standard post-surgery steroid drops after uneventful cataract surgery - Acta Ophthalmol. 2014: 92: 623–628; Jabs- Standardization of Uveitis Nomenclature for Reporting Clinical Data. J Ophthalmol 2005;140:509–516]).

Misurazione dell’infiammazione a livello della camera oculare anteriore dopo estrazione della cataratta tramite bio-microscopia, secondo uno schema di valutazione standard, basato sulla cellularità nella camera oculare anteriore e sul flare nella camera oculare anteriore (rif. [Merkoudis - Comparison of peroperative subconjunctival injection of methylprednisolone and standard post-operative steroid drops after uneventful cataract surgery - Acta Ophthalmol. 2014: 92: 623–628; Jabs- Standardization of Uveitis Nomenclature for Reporting Clinical Data. J Ophthalmol 2005;140:509–516]).

E.5.1.1

Timepoint(s) of evaluation of this end point

Visit 1 - Screening (-4/-7 days before surgery).
Visit 3 - Control 1 (1 day after surgery).
Visit 4 - Control 2 (7+/-1 days after surgery).
Visit 5 - End of treatment (15+/-2 days after surgery).
Visit 6 - Follow-up (60 days after surgery).

Visita 1 - Screening (-4/-7 giorni pre-operazione).
Visita 3 - Controllo 1 (1 giorno dopo l'operazione).
Visita 4 - Controllo 2 (7+/-1 giorni dopo l'operazione).
Visita 5 - Fine del trattamento (15+/-2 giorni dopo l'operazione).
Visita 6 - Follow-up (60 giorni dopo l'operazione).

E.5.2

Secondary end point(s)

Evaluation of adverse events during the study period.

Valutazione degli eventi avversi durante lo Studio.

E.5.2.1

Timepoint(s) of evaluation of this end point

V2, V3, V4, V5 and V6.

V2, V3, V4, V5 e V6.

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

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

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

Yes

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:

100

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

180

F.4.2.2

In the whole clinical trial

180

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)

Patients ending the participation in the trial will be treated as expected according to site standard clinical practice for that condition.

I pazienti partecipanti alla sperimentazione, una volta conclusa, saranno trattati come previsto in base alla comune pratica clinica dell'ospedale per la loro condizione.

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

2016-12-06

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-10-20

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2020-03-31

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IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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