Clinical Trials Register

Summary
EudraCT Number:	2019-004062-17
Sponsor's Protocol Code Number:	NEK/MD/0119
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2020-11-06
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

2019-004062-17

A.3

Full title of the trial

OPEN, COMPARATIVE STUDY TO EVALUATE THE PERFORMANCE AND SAFETY OF THE MEDICAL DEVICE MARIAL® IN ASSOCIATION WITH PROTON-PUMP INHIBITORS VERSUS PPI ALONE IN PATIENTS AFFECTED BY GASTROESOPHAGEAL REFLUX DISEASE

Studio aperto e comparativo per valutare le performance e la safety del dispositivo medico Marial® somministrato in associazione con inibitori di pompa protonica (PPI) versus la sola somministrazione di PPI, in pazienti con malattia da reflusso gastroesofageo

A.3.1

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

A.3.2

Name or abbreviated title of the trial where available

A.4.1

Sponsor's protocol code number

NEK/MD/0119

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	Nekkar Lab srl
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	Nekkar Lab S.r.l
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	Opera Contract Research Organization S.r.l
B.5.2	Functional name of contact point	Alexandru Ciucur
B.5.3	Address:
B.5.3.1	Street Address	Via Cozia 10
B.5.3.2	Town/ city	Timisoara
B.5.3.3	Post code	300209
B.5.3.4	Country	Romania
B.5.4	Telephone number	200353
B.5.6	E-mail	cicur@operacro.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	Marial® - Dispositivo medico (già marcato CE, classe IIa)
D.2.1.1.2	Name of the Marketing Authorisation holder	Nekkar Lab Srl (Italia)
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	MARIAL 20 ORAL STICK 15ML
D.3.2	Product code	[1497963]
D.3.4	Pharmaceutical form	Oral gel
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.3.9.1	CAS number	0037251-44-8
D.3.9.2	Current sponsor code	NL03
D.3.9.3	Other descriptive name	Medical Device for GERD management. Mix of Water, E-Gastryal(R) Magnesium Alginate, Epsiliseen-H, addictives. CE Marketed.
D.3.10	Strength
D.3.10.1	Concentration unit	ml millilitre(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	15
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	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	Dispositivo medico (già marcato CE, classe IIa)
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	Omeprazolo Aurobindo
D.2.1.1.2	Name of the Marketing Authorisation holder	Aurobindo Pharma Italia
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	Omeprazolo Aurobindo 20 mg
D.3.2	Product code	[39758356]
D.3.4	Pharmaceutical form	Gastro-resistant capsule, hard
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.3.9.1	CAS number	73590-58-6
D.3.9.2	Current sponsor code	NL03
D.3.9.3	Other descriptive name	Omeprazole
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	20
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: 3
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	GAVISCON - 250 MG + 133.5 MG COMPRESSE MASTICABILI GUSTO MENTA 24 COMPRESSE
D.2.1.1.2	Name of the Marketing Authorisation holder	RECKITT BENCKISER HEALTHCARE (UK) LIMITED
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	Gaviscon 250 mg + 133,5 mg compresse masticabili gusto fragola
D.3.2	Product code	[054248171]
D.3.4	Pharmaceutical form	Chewable 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.3.9.1	CAS number	9005-38-3
D.3.9.2	Current sponsor code	NL03
D.3.9.3	Other descriptive name	Sodium alginate D-Galacturonic acid sodium salt natriumglucuronat
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	250
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

gastroesophageal reflux disease (GERD)

malattia da reflusso gastroesofageo (GERD)

E.1.1.1

Medical condition in easily understood language

gastroesophageal reflux disease

malattia da reflusso gastroesofageo

E.1.1.2

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

MedDRA Classification

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 performance and safety of Marial® administered in association with PPI (Omeprazole) versus a standard treatment with PPI (Omperazole) alone.

confrontare le prestazioni e la sicurezza di Marial somministrato in associazione con PPI (Omeprazole) rispetto a un trattamento standard con PPI (Omeprazole) da solo

E.2.2

Secondary objectives of the trial

Evaluation of product performance by patient and by Investigator;
Evaluation of safety.

Valutazione delle prestazioni del prodotto da parte del paziente e dello sperimentatore; valutazione della sicurezza

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Male or non-pregnant female, both aged = 18 to = 65 years.
Diagnosis of GERD, Grade A esophagitis on Los Angeles Classification System grades reflux esophagitis by: Gastroscopy (done within 1-month prior baseline) and episodic heartburn and/or acid regurgitation (at least 3 times per week in the last 2 weeks);
Body mass index of = 18.5 to = 36 kg/m2.
Able to communicate adequately with the investigator and to comply with the requirements for the entire study.
Capable of and freely willing to provide written informed consent prior to participating in the study.

Pazienti di sesso maschile o femminile di età = 18 e = 65 anni.
Diagnosi di GERD, con esofagite grado A (secondo Los Angeles Classification System) in base a: gastroscopia (effettuata entro 1 mese prima della baseline) (5); bruciore di stomaco Episodico e/o rigurgito acido (almeno 3 volte a settimana nelle ultime 2 settimane);
Indice di massa corporea = 18,5 e = 36 kg / m2.
Il paziente deve essere in grado di comunicare adeguatamente con lo Sperimentatore e deve soddisfare i requisiti dello studio per la sua intera durata.
Il paziente deve essere in grado e deve avere la volontà di fornire spontaneamente il proprio consenso informato scritto prima di partecipare allo studio clinico

E.4

Principal exclusion criteria

Intake of PPI or Marial® during the last 28 days before the start of the study.
Intake of systemic glucocorticoids or non-steroidal anti-inflammatory drugs (NSAIDs) including COX-2-inhibitors (= 3 consecutive days per week) during the last 28 days before the start of the study; except regular intake of enteric coated aspirin dosages up to 150 mg/d.
Previously underwent acid-lowering surgery or other surgery of the oesophagus and/or upper gastrointestinal tract (excluding appendectomy, cholecystectomy and polypectomy).
History of co-existing disease that affects the oesophagus (e.g. Barrett's oesophagus, Zollinger-Ellison syndrome, oesophageal stricture).
History of active gastric or duodenal ulcers within 3 months of the first dose of the study drug or had acute upper gastrointestinal (GI) bleeding within last 6 months.
Documented presence of severe renal or hepatic insufficiency (i.e. GOT, GPT elevated over double the normal range).
Known hypersensitivity to omeprazole, and/or Marial® and/or Gaviscon®.
Concurrent (or within 30 days of study entry) participation in a clinical trial.
Females who are pregnant, or planning a pregnancy, or lactating.
Females of childbearing potential not using reliable methods of birth control.
Clinically significant laboratory abnormality or disease which, in the opinion of the Investigator, will create a risk for the patient, or interfere with study results (i.e. GOT, GPT elevated over double the normal range).
Receiving any of the following drugs within 2 weeks before the baseline: theophylline, bismuth salts, warfarin, phenytoin, tacrolimus, diazepam, cyclosporine, disulfiram, benzodiazepines, barbiturates, antineoplastic agents, erythromycin, clarithromycin, sucralfate, clopidogrel or protease inhibitors.
Taking concomitant medications that rely on the presence of gastric acid for optimal bioavailability (e.g. ketoconazole, ampicillin esters or iron salts).
Drug or alcohol abuse within 12 months of Day 0
Malignancy (also leukemic infiltrates) within 5 years prior to Day 0 (except for treated basal cell/squamous cell carcinoma of the skin).
Psychosis, schizophrenia, mania, depressive disorders, history of suicide attempt or suicidal ideation, or any other psychiatric illness (except for intermittent anxiety).
Presence of any clinically significant medical condition judged by the investigator to preclude the patient's inclusion in the study for its safety

• Assunzione di PPI o Marial® negli ultimi 28 giorni prima dell'inizio dello studio.
• Assunzione di glucocorticoidi sistemici o di farmaci antinfiammatori non steroidei (NSAIDs) inclusi COX -2 inibitori (= 3 giorni consecutivi a settimana) negli ultimi 28 giorni precedenti l'inizio dello studio; e’ ammessa l’assunzione regolare di aspirina con rivestimento enterico con dosaggio sino a 150 mg / die.
• Paziente sottoposto in precedenza ad intervento chirurgico a livello esofageo e /o del tratto gastrointestinale (esclusa appendicectomia, colecistectomia e polipectomia).
• Anamnesi positiva per ulcera gastrica in fase attiva o gastroduodenale (ad es. esofago di Barrett, Zollinger-Ellison sindrome, stenosi esofageo).
• Anamnesi positiva per ulcera gastrica o duodenale attiva nei 3 mesi precedenti alla prima dose dei prodotti in studio o sanguinamento gastrointestinale superiore (GI) acuto negli ultimi 6 mesi.
• Presenza di grave insufficienza renale o epatica (valori di GOT, GPT oltre il doppio del range di normalità).
• Ipersensibilità nota all'omeprazolo e / o a Marial® e / o a Gaviscon®.
• Partecipazione concomitante (o nei 30 giorni precedenti allo studio) ad altra sperimentazione clinica.
• Donne in gravidanza o in allattamento. Donne in età fertile che potrebbero diventare gravide e che non utilizzano opportune misure contraccettive.
• Anormalita’ di laboratorio clinicamente significativa che, secondo il parere dello Sperimentatore, possa comportare un rischio per il paziente o interferire con i risultati dello studio (per esempio valori di GOT, GPT oltre il doppio del normale)
• Pazienti che assumono nelle 2 settimane prima della baseline: teofillina, sali di bismuto, warfarin, fenitoina, tacrolimus, diazepam, ciclosporina, disulfiram, benzodiazepine, barbiturici, agenti antineoplastici, eritromicina, claritromicina, sucralfate, clopidogrel o inibitori della proteasi.
• Assunzione di farmaci concomitanti che richiedono presenza di acido gastrico per avere biodisponibilità ottimale (ad esempio ketoconazolo, esteri di ampicillina o sali di ferro).
• Abuso di droghe o alcool nei 12 mesi precedenti l'inizio dello studio.
• Evidenza di tumore maligno (comprendendo anche le leucemie) nei 5 anni precedenti l'inizio dello studio (ad eccezione di carcinoma basocellulare / carcinoma cutaneo spinocellulare in trattatamento).
• Psicosi, schizofrenia, mania, disturbi depressivi, anamnesi di tentativi di suicidio o ideazione suicidaria, o qualsiasi altra malattia psichiatrica (tranne l'ansia intermittente).
• Presenza di una qualsiasi condizione medica che sia stata giudicata clinicamente significativa dallo Sperimentatore e tale da precludere l’inclusione del paziente nello studio.

E.5 End points

E.5.1

Primary end point(s)

The performance in and between the two arms will be evaluated by number of rescue medicine used (Gaviscon®)

Per comparare i due bracci dello studio (omeprazolo da solo versus omeprazolo associato a Marial) sara’ valutato il consumo di Gaviscon (rescue medication) utilizzato dai pazienti

E.5.1.1

Timepoint(s) of evaluation of this end point

28 (± 1) days

28 (±1) giorni

E.5.2

Secondary end point(s)

Reflux symptoms index (RSI).
Questionnaire for patient: GERD Impact Scale (GIS).
Investigator Global Assessment of the Performance (IGAP) using a 4- point scale. IGAP will be evaluated at the last visit of 1st and 2nd study period, only.
GERD Health-Related Quality of Life (GERD-HRQL).
Investigator Global Assessment of Safety (IGAS): using a 4-point scale. IGAS will be evaluated at the last visit of 1st and 2nd study period, only.
Patient Global Assessment of Safety (PGAS): in the patient diary using a 4-point scale
Safety assessment by AE/ADE/SAE/SADE/DD.

• Reflux symptom Index (RSI).
• Questionario per paziente: GERD Impact Scale (GIS).
• Investigator Global Assessment of the Performance (IGAP) utilizzando la scala a 4 punti: 1 = ottima performance , 2 = buona performance, 3 = performance moderata e 4 = scarsa performance.
• GERD Health-Related Quality of Life (GERD-HRQL).
• Valutazione globale della safety da parte dello Sperimentatore (IGAS): utilizzando la scala a 4 punti:1 = ottima safety, 2 = buona safety, 3 = safety moderata e 4 = scarsa safety.
• Valutazione globale per la safety da parte del Paziente (PGAS): indicata dal paziente nel diario. Valutata mediante la scala a 4 punti: 1 = ottima performance, 2 = buona performance, 3 = performance moderata e 4 = scarsa performance.
• Valutazione della safety attraverso la raccolta di AE/SAE/SADE.

E.5.2.1

Timepoint(s) of evaluation of this end point

28 (± 1) days
180 (± 10) days

28 (±1) giorni (fine del periodo di comparazione tra i due bracci di trattamento)
180 (±10) giorni (fine del periodo di follow up; dal 29 al 180 giorno il trattamento e’ solo Marial)

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)

E.7.4

Therapeutic use (Phase IV)

Yes

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

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

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

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

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

The date of termination of the 1st period of study (comparative study with two arms of treatment) will be visit 3 of the last enrolled subject.
The date of termination of the 2nd period of study (follow up, non-comparative, only with Marial) will be visit 4 of the last enrolled subject

La data di fine del 1 ° periodo di studio (studio comparativo tra due bracci di trattamento) e’ la visita 3 (28 giorno).
La data di fine del 2 ° periodo di studio (follow-up, non comparativo in cui tutti i pazienti sono trattati con Marial) e’la 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:

110

F.1.3

Elderly (>=65 years)

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

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

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

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

2020-11-24

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-12-03

P. End of Trial
P.	End of Trial Status	Ongoing

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Clinical trials