Clinical Trials Register

Summary
EudraCT Number:	2016-004159-56
Sponsor's Protocol Code Number:	MERISUDD
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:	2021-05-25
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

2016-004159-56

A.3

Full title of the trial

Efficacy and safety of mesalazine, rifaximin, alone or as extemporary combination, in the treatment of symptomatic uncomplicated diverticular disease of colon: multi-centre, randomised, double-blind, double - dummy, parallel group, placebo-controlled study (MERISUDD study)

Appropriatezza d¿uso di Mesalazina e/o di Rifaximina nel trattamento della malattia diverticolare sintomatica non complicata del colon: studio multicentrico, randomizzato, doppio cieco, doppio dummy, controllato verso placebo (studio MERISUDD)

A.3.1

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

Efficacy and safety of mesalazine, rifaximin, alone or as extemporary combination, in the treatment of symptomatic uncomplicated diverticular disease of colon

Appropriatezza d¿uso di Mesalazina e/o di Rifaximina nel trattamento della malattia diverticolare sintomatica non complicata del colon

A.3.2

Name or abbreviated title of the trial where available

Efficacy and safety of mesalazine, rifaximin, alone or as extemporary combination, in the treatment

Appropriatezza d¿uso di Mesalazina e/o di Rifaximina nel trattamento della malattia diverticolare si

A.4.1

Sponsor's protocol code number

MERISUDD

A.5.4

Other Identifiers

Name:

MERISUDD

Number:

MERISUDD

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	DIPARTIMENTO DI MEDICINA CLINICA E CHIRURGIA - UNIVERSITÀ DEGLI STUDI DI NAPOLI FEDERICO II
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	AIFA - Italian Medicines Agency
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	LB Research
B.5.2	Functional name of contact point	Flavia Baruzzi
B.5.3	Address:
B.5.3.1	Street Address	via Lombardia 81
B.5.3.2	Town/ city	Cant¿
B.5.3.3	Post code	22063
B.5.3.4	Country	Italy
B.5.4	Telephone number	031734908
B.5.5	Fax number	0317372218
B.5.6	E-mail	flavia.baruzzi@lbresearch.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	NORMIX - 200 MG COMPRESSE RIVESTITE CON FILM 12 COMPRESSE
D.2.1.1.2	Name of the Marketing Authorisation holder	ALFA WASSERMANN 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	Rifaximina
D.3.2	Product code	Rifaximina
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	RIFAXIMINA
D.3.9.1	CAS number	80621-81-4
D.3.9.2	Current sponsor code	rifaximina
D.3.9.4	EV Substance Code	SUB10312MIG
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	200
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	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	ASACOL - 800 MG COMPRESSE GASTRORESISTENTI 60 COMPRESSE
D.2.1.1.2	Name of the Marketing Authorisation holder	GIULIANI SPA
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	mesalazina
D.3.2	Product code	mesalazina
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	5-ASA (ACIDO-5-AMINOSALICILICO) (MESALAZINA)
D.3.9.1	CAS number	89-57-6
D.3.9.2	Current sponsor code	mesalazina
D.3.9.4	EV Substance Code	ND
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	800
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	Tablet
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Tablet
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

Treatment of symptomatic uncomplicated diverticular colon disease (SUDD)

trattamento della malattia diverticolite sintomatica non complicata del colon (SUDD)

E.1.1.1

Medical condition in easily understood language

Treatment of symptomatic uncomplicated diverticular colon disease (SUDD)

trattamento della malattia diverticolite sintomatica non complicata del colon (SUDD)

E.1.1.2

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

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	10013538
E.1.2	Term	Diverticulitis
E.1.2	System Organ Class	10021881 - Infections and infestations

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The primary objective is to evaluate the efficacy of non-absorbable antibiotics (i.e. rifaximin) and/or anti-inflammatory drugs (i.e. mesalazine) in the prevention of diverticulitis in patients with symptomatic uncomplicated diverticular disease of the colon

L'obiettivo primario ¿ di valutare l'efficacia di antibiotici a basso assorbimento (rifaximina) e/o di farmaci anti-infiammatori (mesalazina) nella prevenzione della diverticolite in pazienti affetti da malattia diverticolare sintomatica non complicata del colon

E.2.2

Secondary objectives of the trial

To evaluate the efficacy of rifaximin and/or mesalazine on symptoms 'relief and quality of life in patients with symptomatic uncomplicated diverticular disease of the colon;
To address the risk / benefit and cost / benefit profile of rifaximin and/or mesalazine treatment of patients in the long-term treatment of patients with symptomatic uncomplicated diverticular disease of the colon

Valutare l'efficacia di rifaximina e/o mesalazina sul miglioramento della sintomatologia e sulla qualit¿ della vita in pazienti affetti da malattia diverticolare sintomatica non complicata del colon;
Determinare i profili rischio/beneficio e costo/beneficio di rifaximina e mesalazina nel trattamento a lungo termine di pazienti affetti da malattia diverticolare sintomatica non complicata del colon.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. In- or out-patients of both genders aged = 18 and = 75 years;
2. Patients with diverticular disease diagnosed by colonoscopy performed not before than 6 months before the enrolment in the study;
3. Patients with symptoms related to uncomplicated diverticular disease (i.e. abdominal pain, abdominal discomfort, bloating, flatulence) recurrent at least in the last six months;
Symptoms will be evaluated according to a structured questionnaire, based on a 5-point Likert scale, assessing frequency and based on a 10-point Likert scale, assessing severity. Patients will be considered eligible for the study when the abdominal pain total score (frequency plus severity) will be = 6 (independently of other gastrointestinal symptoms);
4. Written informed consent to participate in the study obtained according to GCP;
5. Patients able to comprehend the full nature and the purpose of the study, including possible risks and side effects, and able to cooperate with the Investigator and to comply with the requirements of the entire study (including ability to attend all the planned study visits according to the time limits), based on Investigator’s judgement;
6. Female subjects of childbearing potential (i.e., not permanently sterilised - post hysterectomy or tubal ligation status – or not postmenopausal) must be using an appropriate method of contraception according to the definition of Note 3 of ICH M3 Guideline.

1. Pazienti in ricovero o ambulatoriali di entrambi i sessi di età = 18 e = 75 anni;
2. Pazienti con malattia diverticolare diagnosticata attraverso colonscopia effettuata entro i 6 mesi precedenti l’arruolamento nello studio;
3. Pazienti con sintomatologia legata a malattia diverticolare non complicata (dolore addominale, fastidio addominale, gonfiore, flatulenza) con almeno una recidiva negli ultimi sei mesi;
I sintomi saranno valutati attraverso un questionario strutturato, basato su di una scala Likert a 5 punti per la valutazione della frequenza e su di una scala Likert a 10 punti per la valutazione della severità.
I pazienti saranno considerati idonei allo studio quando la media del punteggio totale di dolore addominale (frequenza più severità) sarà = 6 (indipendentemente da altri sintomi gastrointestinali);
4. Consenso informato scritto alla partecipazione allo studio ottenuto secondo GCP;
5. Pazienti che a giudizio dello Sperimentatore siano in grado di comprendere a pieno la natura e lo scopo dello studio, inclusi i possibili rischi e reazioni avverse, ed in grado di relazionarsi con lo Sperimentatore ed attenersi alle richieste dell’intero studio (inclusa la capacità di sottoporsi a tutte le visite previste nel rispetto delle tempistiche indicate);
6. I soggetti femminili in età fertile (cioè donne non sterilizzate permanentemente – sottoposte a rimozione dell’utero o legatura delle tube – o non in menopausa) devono adottare un appropriato metodo di contraccezione, in accordo a quanto riportato nella Nota 3 alle linee guida ICH M3.

E.4

Principal exclusion criteria

1. Patients with acute diverticulitis (both complicated and uncomplicated);
2. Patients with diverticular colitis;
3. Patients with solitary diverticulum of the colon;
4. Patients with active or recent peptic ulcer;
5. Patients with chronic liver, renal or hematologic diseases;
6. Patients with known allergy to salicylates;
7. Patients with previous major abdominal surgery;
8. Patients with concomitant colonic or extra colonic cancer or history of malignancy;
9. Patients with concomitant inflammatory bowel disease and celiac disease;
10. Use of antibiotics, probiotics and laxatives in the previous 4 weeks;
11. Use of non-steroidal anti-inflammatory drugs (NSAIDs) other than acetylsalicylic acid in the last 4 weeks before study entry and throughout the overall study period. Acetylsalicylic acid and paracetamol may be taken in the last 4 weeks before study entry and throughout the overall study period;
12. Patients with intended or ascertained pregnancy, lactation or women of childbearing age not using contraceptives;
13. Patients with recent history or suspicion of alcohol abuse or drug addiction;
14. Patients unable to give a valid informed consent or to properly follow the protocol procedures;
15. Concomitant participation in another study or participation in the evaluation of any investigational drugs/devices during 3 months before this study or previous participation in the same investigation;
16. The participation in the investigation is also not permitted to employees of the investigational site with direct involvement in the study or in other studies under the direction of that Investigator, as well as family members of the employees or the Investigator.

1. Pazienti con diverticolite acuta (sia complicata che non);
2. Pazienti con colite diverticolare;
3. Pazienti con isolato diverticolo del colon;
4. Pazienti con attiva o recente ulcera peptica;
5. Pazienti con malattie croniche di fegato, rene o ematologiche;
6. Pazienti con allergia nota ai salicilati;
7. Pazienti con precedente chirurgia addominale maggiore;
8. Pazienti con concomitante cancro al colon o extra-colon o storia di tumori maligni;
9. Pazienti con concomitante malattia infiammatoria cronica intestinale e celiachia;
10. Utilizzo di antibiotici, probiotici e lassativi nelle 4 settimane precedenti;
11. Utilizzo di farmaci anti-infiammatori non steroidei (FANS), ad eccezione dell’acido acetilsalicilico, nelle 4 settimane precedenti l’entrata in studio e per tutta la durata dello studio stesso. L’acido acetilsalicilico ed il paracetamolo possono essere assunti nelle 4 settimane precedenti l’entrata in studio e per tutta la durata dello studio stesso;
12. Pazienti donne con intenzione di intraprendere una gravidanza, in accertato stato di gravidanza, in allattamento o in età fertile che non utilizzino contraccettivi;
13. Pazienti con storia recente o presunto abuso di alcol e dipendenza da droghe;
14. Pazienti che non siano in grado di fornire un valido consenso informato o di seguire in modo appropriato le procedure previste dal protocollo;
15. Partecipazione concomitante o nei 3 mesi precedenti il presente studio ad un altro studio o indagine su un qualsiasi altro farmaco/dispositivo medico, o precedente partecipazione al presente studio;
16. La partecipazione allo studio non è altresì permessa agli impiegati presso il centro sperimentale con diretto coinvolgimento nello studio o in altri studi condotti dallo stesso Sperimentatore, così come familiari dei suddetti impiegati o dello Sperimentatore.

E.5 End points

E.5.1

Primary end point(s)

• Rate of patients with episodes of acute diverticulitis and/or complications.
An episode of diverticulitis will be defined based on:
a) Signs and symptoms (i.e. pain, fever, abdominal tenderness);
b) Laboratory tests: erythro-sedimentation rate (ESR), high-specificity C-reactive protein (hs-CRP), increase in white blood cells (WBCs) count;
c) Abdominal computerised tomography (CT).

• Percentuale di pazienti con episodi di diverticolite acuta e/o complicazioni.
Un episodio di diverticolite sarà definito in base a:
a) Segni e sintomi (dolore, febbre, indolenzimento addominale);
b) Test di laboratorio (velocità di eritro-sedimentazione (VES), Proteina C-reattiva altamente specifica (hs-CRP), aumento delle conte leucocitarie (WBC));
c) Tomografia computerizzata (CT) addominale.

E.5.1.1

Timepoint(s) of evaluation of this end point

Extra-visits can be arranged at any time during the study on patient’s request in case of signs and symptoms suggestive of acute diverticulitis and/or complications, in which the investigator will perform further physical examination, laboratory and TC to confirm or exclude this diagnosis (primary variable).

Visite aggiuntive potranno essere effettuate in qualsiasi momento durante lo studio, su richiesta del paziente in caso di segni e sintomi indicativi di diverticolite acuta e / o complicanze, durante le quali lo sperimentatore effettuerà un ulteriore esame fisico, esami di laboratorio e una TC per confermare o escludere la diagnosi ( Variabile primaria).

E.5.2

Secondary end point(s)

¿ Global symptoms score (abdominal pain, abdominal discomfort, bloating, flatulence) and changes in bowel habits (number of bowel movements and corresponding defecatory symptoms, i.e. urgency, straining, and feeling of incomplete evacuation); ¿ Rate of patients completely asymptomatic; ¿ Stool consistency, as evaluated by using the Bristol Stool Form Scale (BSFS); ¿ Use of additional medications (acetylsalicylic acid, paracetamol, antispastics, laxatives, antidiarrhoics); ¿ Number of medical consultations; ¿ Working days lost; ¿ Quality of life (Short-Form 36) ¿ Adverse Events (AEs) and Treatment Emergent AEs (TEAEs) occurring at any time during the study; ¿ Vital signs (blood pressure, heart rate, body mass index, body temperature); ¿ Laboratory tests (haematology and blood chemistry); ¿ Physical examination.

¿ Punteggio globale dei sintomi (dolore addominale, fastidio addominale, gonfiore, flatulenza) e cambiamento nelle abitudini intestinali (numero di movimenti intestinali e corrispondenti sintomi di defecazione, cio¿ urgenza, sforzo e sensazione di incompleta evacuazione); ¿ Percentuale di pazienti completamente asintomatici; ¿ Consistenza delle feci, valutata secondo la Bristol Stool Form Scale (BSFS); ¿ Utilizzo delle terapie aggiuntive (acido acetilsalicilico, paracetamolo, antispastici, lassativi, antidiarroici); ¿ Numero di consultazioni mediche; ¿ Giorni di lavoro persi; ¿ Qualit¿ della vita (questionario Short-Form 36). ¿ Eventi Avversi (AE) ed Eventi Avversi Emergenti dal Trattamento (TEAE) che si manifestino in qualsiasi momento durante lo studio; ¿ Segni vitali (pressione sanguigna, frequenza cardiaca, indice di massa corporea, temperature corporea); ¿ Test di laboratorio (ematologia e chimica del sangue); ¿ Esame fisico.

E.5.2.1

Timepoint(s) of evaluation of this end point

At each visit. The laboratory tests will be performed at the screening visit, after 6, 12, 18 and 24 months of treatment.

Ad ogni visita, fatta eccezione degli esami di laboratorio che, vengono effettuati, alla visita di screening, dopo 6, 12, 18 e mesi 24 di trattamento.

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

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

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

Yes

E.8.1.7.1

Other trial design description

doppio dummy

double dummy

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

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

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:

410

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

410

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

820

F.4.2

For a multinational trial

F.4.2.1

In the EEA

820

F.4.2.2

In the whole clinical trial

820

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

nessuna

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

2017-10-12

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-05-05

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

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Clinical trials