Clinical Trials Register

Summary
EudraCT Number:	2017-003722-33
Sponsor's Protocol Code Number:	REROS/001/17
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:	2018-01-10
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

2017-003722-33

A.3

Full title of the trial

Safety and Efficacy of Rifaximin Delayed Release 400 mg Tablets in Patients with Moderate-to-Severe Papulopustular Rosacea and Positive Lactulose Breath Test. A Multicenter Double-Blind, Placebo-Controlled Randomized Clinical Trial.

Sicurezza ed efficacia di Rifaximina, compresse a rilascio ritardato da 400 mg, in pazienti con rosacea papulo-pustolosa moderata-severa e positività al breath test al lattulosio. Uno studio clinico multicentrico, in doppio-cieco, randomizzato e controllato verso placebo”.

A.3.1

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

Phase II clinical trial, conducted in different sites, with random assignation of treatment, where neither the patient or the medical doctor know the assigned treatment, drug or placebo, to evaluate the efficacy and safety of Rifaximin delayed release 400 mg tablet in Patients with Moderate-to-Severe Papulopustular Rosacea and Positive Lactulose Breath Test

Studio clinico di fase II, condotto in siti differenti, con assegnazione random del trattamento, in cui né il paziente né il medico conoscono il trattamento assegnato, attivo o placebo, per valutare efficacia e sicurezza di Rifaximina compresse da 400 mg a rilascio ritardato in pazienti con rosacea papulo-pustolosa moderata-severa e positività al breath test al lattulosio.

A.3.2

Name or abbreviated title of the trial where available

REROS TRIAL

Studio Clinico REROS

A.4.1

Sponsor's protocol code number

REROS/001/17

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	ALFASIGMA S.P.A.
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	ALFASIGMA 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	ALFASIGMA S.P.A.
B.5.2	Functional name of contact point	Clinical Trials - R&D
B.5.3	Address:
B.5.3.1	Street Address	Via Ragazzi del '99, 5
B.5.3.2	Town/ city	Bologna
B.5.3.3	Post code	40133
B.5.3.4	Country	Italy
B.5.4	Telephone number	00390516489619
B.5.5	Fax number	00390516489671
B.5.6	E-mail	alessandro.ble@alfasigma.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	No
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	Rifaximin delayed release 400 mg
D.3.2	Product code	Rifaximin-EIR
D.3.4	Pharmaceutical form	Coated 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	RIFAXIMIN
D.3.9.1	CAS number	80621-81-4
D.3.9.2	Current sponsor code	Rifaximin-EIR
D.3.9.3	Other descriptive name	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	400
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	Coated 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

Moderate-to-Severe Papulopustular Rosacea and Positive Lactulose Breath Test

Rosacea papulo-pustolosa moderata-severa e positività al breath test al lattulosio

E.1.1.1

Medical condition in easily understood language

Moderate-to-Severe Papulopustular Rosacea and Positive Lactulose Breath Test

Rosacea papulo-pustolosa moderata-severa e positività al breath test al lattulosio

E.1.1.2

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

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	10076537
E.1.2	Term	Papulopustular rosacea
E.1.2	System Organ Class	10040785 - Skin and subcutaneous tissue 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 investigate the safety and efficacy of oral Rifaximin-EIR (rifaximin delayed release) versus placebo in adults with moderate-to-severe papulopustular rosacea (a.k.a. subtype II) and positive lactulose H2/CH4 breath test.

Investigare la sicurezza e l’efficacia di un trattamento orale con Rifaximina-EIR (rifaximina a rilascio ritardato) in confronto con placebo in adulti affetti da rosacea papulo-pustolosa di tipo moderato-severo (a.k.a. sottotipo II) e test dell’espirato al lattulosio positivo (H2/CH4 breath test).

E.2.2

Secondary objectives of the trial

To evaluate the degree of concordance between three methods of rosacea grading (clinical direct assessment, centralized expert assessment (dermatologist) from patient’s photographs and centralized assessment (trained technician) from patient’s photographs after computerized advanced processing.

Valutare il grado di concordanza fra tre metodi di valutazione della rosacea (valutazione clinica diretta, valutazione centralizzata di un esperto (dermatologo) sulla base di fotografie dei pazienti e valutazione centralizzata (tecnico trainato) su fotografie di pazienti dopo avanzata elaborazione computerizzata.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

All the following criteria must be met both at the Screening (V1) and the Randomization (V2) visit unless otherwise specified.
1)Men and women aged 18 to 70 years at screening (V1)
2)Female participants are eligible if they are:
•of non-childbearing potential, i.e.: i) post-menopausal (at least 2 years without spontaneous menses), or ii) surgically sterile (bilateral tubal occlusion, or hysterectomy), or iii) ablation of both ovaries or
•of childbearing potential with a negative pregnancy test result at screening and randomization and agreeing to use a highly effective method of contraception (i.e. with failure rate of less than 1% per year) until 72 hours after taking the last study treatment dose.
3)Moderate-to-severe papulopustular rosacea (a.k.a. subtype II, RII,) at screening and confirmed at randomization. Moderate-to-severe rosacea is defined as the presence of 11 or more facial papules or pustules with or without plaques.
4)Positivity of lactulose H2/CH4 breath test (L-BT) within the last 2-weeks before randomization.
5)Patients accepting to provide and legally capable of providing free and informed consent to all procedures included in the protocol (including facial skin photography).

Tutti i seguenti criteri devono essere soddisfatti sia allo screening (V1) che alla visita di randomizzazione (V2) a meno che non sia differentemente specificato.
1.Maschi e femmine di età compresa tra 18 e 70 anni al momento dello screening (V1).
2.Le partecipanti di sesso femminile sono arruolabili se:
•non sono fertili, ad esempio: i) presenza di menopausa (da almeno due anni senza mestruazioni spontanee), o ii) sterilizzate chirurgicamente (occlusione bilaterale delle tube o isterectomia), o iii) asportazione di entrambe le ovaie.
•sono fertili ma abbiano un test di gravidanza negativo allo screening ed alla randomizzazione e siano d’accordo ad utilizzare un metodo contraccettivo altamente efficace (es.: con un tasso di fallimento inferiore a 1% annuo) fino a 72 ore dopo l’ultima assunzione del trattamento in studio.
3.Rosacea papulo-pustolosa di grado moderato- severo (sottotipo a.k.a. II, RII) allo screening e confermata alla randomizzazione. La Rosacea si definisce di moderata-severa intensità se vi è la presenza di 11 o più papule o pustole facciali con o senza placche.
4.Positività al breath test al lattulosio (H2/CH4 breath test (L-BT)) effettuato entro le due settimane prima della randomizzazione.
5.Pazienti che accettano di prestare e che sono legalmente capaci di prestare un consenso libero ed informato a tutte le procedure incluse nel protocollo (inclusa l’acquisizione fotografica del volto).

E.4

Principal exclusion criteria

All the following criteria must be met both at the Screening (V1) and the Randomization (V2) visit unless otherwise specified.
1)Granulomatous rosacea or rosacea fulminans.
2)Erythematoteleangectatic, phymatous or ocular rosacea only. Patients with these subtypes associated with papulopustular rosacea can be enrolled.
3)Circulating anti-helicobacter pylori IgM and/or IgG at screening (V1).
4)Positivity at the faecal Clostridium Difficile toxin assay at screening (V1).
5)History or family history of inflammatory bowel disease (Crohn’s disease or ulcerative colitis) or other conditions characterized by severe intestinal ulcers.
6)History or family history of coeliac disease.
7)Patients with intestinal obstruction or partial intestinal obstruction.
8)Presence of diarrhoea associated with fever and/or blood in the stool.
9)Health conditions requiring continuous or intermittent treatment with facial topical, inhaled or systemic steroids and/or biologic or non-biologic immunosuppressive or immunomodulatory agents (e.g. autoimmune diseases, etc.).
10)Severe kidney impairment (i.e. estimated glomerular filtration rate <30 ml/min).
11)Severe hepatic impairment (i.e. Child-Pugh B or C).
12)Cancer or any cancer-related treatment within 5 years prior to screening (excluding non-melanoma skin-cancer).
13)History of alcohol or drug abuse within a year prior to screening.
14)Facial skin conditions that can interfere with reliable assessment of rosacea throughout the study (e.g. keloids, hypertrophic scarring, recent facial surgery etc.)
15)Any other significant health condition (e.g. cardiovascular, respiratory, renal, hepatic, neurologic, psychiatric, hematologic, oncologic, immune etc.) that in the investigator’s judgement may:
i)jeopardize the patient’s safe participation in the trial or
ii)make unlikely the patient’s completion of the study or
iii)make unlikely the patient’s compliance with the study procedures (e.g. highly anticipated need of non-permitted treatments, terminal illness, etc.).
16)History of hypersensitivity to rifaximin, rifamycin-derivatives, any of the rifaximin-EIR excipients, or any UV protection cream component.
17)Treatment with biologic immunomodulatory and/or immunosuppressive drugs (e.g. anti-TNF drugs) within 6 months prior to randomization.
18)Treatment with non-biologic immunomodulatory and/or immunosuppressive drugs (e.g. cyclosporine, methotrexate etc.) within 30 days prior to randomization.
19)Treatment with warfarin within 14 days prior to randomization.
20)Treatment with niacin within 30 days prior to randomization.
21)Topical facial or systemic antibiotics within 30 days before randomization;
22)Treatment with neomycin or other low-absorbable oral antibiotics (such as marketed rifaximin) within 90 days before randomization.
23)Topical facial, inhaled or systemic corticosteroids within 30 days prior to randomization.
24)Topical facial retinoids within 30 days before randomization.
25)Systemic retinoids within 6 months before randomization.
26)Any other topical or systemic treatment for rosacea within 30 days before randomization (including also laser and pulsed light, etc.).
27)Pharmaceutical prebiotics and probiotics (functional food is allowed), within 30 days before randomization.
28)Any experimental treatment within 6 months prior to randomization.
29)Women who are pregnant, breast-feeding or planning a pregnancy during the trial period.

Tutti i seguenti criteri devono essere soddisfatti sia allo screening (V1) che alla visita di randomizzazione (V2) a meno che non sia differentemente specificato.
1)Rosacea Granulomatosa o rosacea fulminante.
2)Rosacea esclusivamente Eritematosa-teleangectasica, fimatosa o oculare. I pazienti con questi sottotipi associati con la rosacea papulo-pustolosa possono essere arruolati.
3)Presenza di IgM e/o IgG anti-helicobacter pylori circolanti allo screening (V1).
4)Positività per la presenza nelle feci della tossina da Clostridium Difficile allo screening (V1).
5)Anamnesi positiva o familiarità per una malattia infiammatoria intestinale (Morbo di Crohn o colite ulserosa) o altre condizioni caratterizzate da una presenza severa di ulcere intestinali.
6)Anamnesi positiva o familiarità per il morbo celiaco.
7)Pazienti con ostruzione intestinale o ostruzione intestinale parziale.
8)Presenza di diarrea associata con febbre e/o sangue nelle feci.
9)Condizioni di salute che richiedano trattamenti continuativi o intermittenti con steroidi per uso topico facciale, inalatorio o sistemico e/o agenti immunosoppressori o immunomodulatori di tipo biologico o non-biologico (per es.: malattie autoimmuni, etc.).
10)Severa insufficienza renale (ad es.: filtrazione glomerulare stimata < <30 ml/minuto).
11)Severa insufficienza epatica (per es.: Child-Pugh B o C).
12)Cancro o qualsiasi trattamento correlato col cancro assunto entro i 5 anni precedenti lo screening (esclusi altri tipi di cancro cutaneo differenti dal melanoma).
13)Storia di abuso di alcool o di farmaci nell’anno precedente lo screening.
14)Condizioni cutanee del viso che possano interferire con una valutazione oggettiva della rosacea durante lo studio (per es.: cheloidi, cicatrici ipertrofiche, interventi di chirurgia facciale recenti, etc.).
15)Qualsiasi altra condizione di salute (per es.: cardiovascolare, respiratoria, renale, epatica, neurologica, psichiatrica, ematologica, oncologica, immunitaria, etc.) che in base al giudizio del medico possa:
i)mettere a repentaglio la sicurezza del paziente partecipando allo studio o,
ii)renda poco verosimile il completamento dello studio da parte del paziente o,
iii)renda poco verosimile la capacità del paziente di eseguire le procedure di studio (per es.: un’alta probabilità di necessità di trattamenti non consentiti, malattie terminali, etc.).
16)Anamnesi positiva per ipersensibilità alla rifaximina, ai derivati della rifamicina, a qualsiasi eccipiente contenuto nella formulazione rifaximina-EIR, o ad un qualsiasi componente della crema protettiva ai raggi UV.
17)Trattamento con farmaci mmunomodulatori biologici e/o immunosoppressori (per es.: farmaci anti-TNF) entro 6 mesi precedenti la randomizzazione.
18)Trattamento con farmaci immunomodulatori non biologici e/o immunosoppressori (per es.: Ciclosporine, metotrexato, etc.) entro 30 giorni precedenti la randomizzazione.
19)Trattamento con warfarin entro 14 giorni precedenti la randomizzazione.
20)Trattamento con niacina entro 30 giorni precedenti la randomizzazione.
21)Antibiotici topici del viso o sistemici entro 30 giorni precedenti la randomizzazione.
22)Trattamento con neomicina o altri antibiotici orali a basso assorbimento (come la rifaximina in commercio) entro 90 giorni precedenti la randomizzazione.
23)Corticosteroidi per uso topico facciale, inalatorio o sistemico entro 30 giorni precedenti la randomizzazione.
24)Retinoidi per uso topico facciale entro 30 giorni precedenti la randomizzazione.
25)Retinoidi per uso sistemico entro 6 mesi precedenti la randomizzazione.
26)Qualsiasi altro trattamento topico o sistemico per la rosacea entro 30 giorni precedenti la randomizzazione (inclusi anche il laser, la luce pulsata, etc.).
27)Prebiotici e probiotici farmaceutici (alimenti funzionali sono permessi), entro 30 giorni precedenti la randomizzazione.
28)Qualsiasi trattamento sperimentale entro 6 mesi precedenti la randomizzazione.
29)Donne che sono in gravidanza, che allattano o che stanno pianificando una gravidanza durante il periodo di studio.

E.5 End points

E.5.1

Primary end point(s)

The following co-primary efficacy endpoints will be clinically assessed by the Investigator:
1)Mean change from baseline (V2) in number of rosacea inflammatory lesions (papules, pustules or plaques) at V4.
2)Percent of participants showing treatment success (IGA score of 0 [clear] or 1 [almost clear]) at V4 (see Appendix 1 of the protocol.)
Success of the study will be declared in any of the active treatment groups if both the co-primary efficacy endpoints will be satisfied (note: the two items may not necessarily occur in the same patient).

I seguenti endpoint co-primari di efficacia saranno valutati clinicamente dallo Sperimentatore:
1)Cambiamento medio, rispetto al basale (V2), del numero di lesioni infiammatorie (papule, pustole o placche) a V4.
2)Percentuale di partecipanti che mostrano un successo terapeutico (punteggio IGA pari a 0 [assente] o 1 [quasi assente]) a V4 (vedere Appendice 1 del protocollo).
Il successo dello studio sarà dichiarato per qualsiasi gruppo di trattamento attivo se entrambi gli endpoint co-primari di efficacia saranno soddisfatti (nota: i due criteri non devono necessariamente essere soddisfatti negli stessi pazienti).

E.5.1.1

Timepoint(s) of evaluation of this end point

30 days from randomization

30 giorni dalla randomizzazione

E.5.2

Secondary end point(s)

The following endpoints will be assessed using standardized photographs:
1)Mean change from Baseline (V2) in number of rosacea inflammatory lesions at V4 as provided by Canfield Image Analysis.

Other secondary efficacy endpoints:
The following secondary efficacy endpoints (i.e. from 1 to 5) will be assessed by the investigator:
1)Mean change from Baseline (V2) in number of inflammatory lesions (papules, pustules or plaques) at V3, V5.
2)Percent of participants showing treatment success (i.e. IGA score of 0 or 1) at V3, V5.
3)Percent of participants with IGA score of 0 (clear) at V3, V4, V5.
4)Mean change from Baseline (Randomization, V2) in the following rosacea additional features at V3, V4, V5.
•burning or stinging (measured using a 0-10 cm Visual Analogue Scale (VAS))
•telangiectasia (absent=0, mild=1, moderate=2, severe=3)
•ocular manifestations (absent=0, mild=1, moderate=2, severe=3),
•phymatous changes (absent=0, mild=1, moderate=2, severe=3).
5)Mean change from Baseline in facial non-transient erythema at V3, V4, V5 (absent=0, mild=1, moderate=2, severe=3).

The following endpoints (i.e. 6 and 7) will be assessed using standardized photographs:
6)Mean change from Baseline (V2) in number of inflammatory lesions at V3, V5 as provided by Canfield Image Analysis.
7)Mean change from Baseline in facial non-transient erythema score at V3, V4, V5, based on global fractional area redness as provided by Canfield Image Analysis.
Additionally, the following secondary endpoints will also be evaluated:
8)Mean change from Baseline in Basic Self-Esteem Scale at V4, V5.
9)Mean change from Baseline in Dermatology Life Quality Index (10-item DLQI) at V4, V5.
10)Mean difference in Treatment Satisfaction Questionnaire between study groups at V4.
The following exploratory secondary endpoint will be evaluated at the sites able to collect and store serum samples:
11) Mean change from Baseline in circulating inflammatory marker levels at V3, V4, V5.
Additional exploratory endpoint:
The following endpoint will be assessed using standardized photographs
12)Mean change from baseline skin texture index at V3, V4, and V5 as provided by Canfield Image Analysis.

Principale endpoint secondario di efficacia:
Il seguente endpoint sarà valutato utilizzando fotografie standardizzate:
1)Cambiamento medio, rispetto al Basale (V2), del numero di lesioni infiammatorie a V4, valutato secondo l’analisi delle immagini effettuata da Canfield.

Altri endpoint secondari di efficacia:
I seguenti endpoint di efficacia secondaria (da 1 a 5) saranno valutati dallo Sperimentatore:
1)Cambiamento medio, rispetto al Basale (V2), del numero di lesioni infiammatorie (papule, pustole o placche) a V3 e V5.
2)Percentuale di partecipanti che mostrano un successo terapeutico (punteggio IGA pari a 0 o 1) a V3 e V5.
3)Percentuale di partecipanti con punteggio IGA pari a 0 (assenza) a V3, V4 e V5.
4)Cambiamento medio rispetto al Basale (Randomizzazione, V2) nelle seguenti caratteristiche addizionali della rosacea a V3, V4 e V5:
•Bruciore o senso di puntura (misurato usando una Scala Analogico Visiva da 0-10 cm (VAS)).
•Telangiectasia (assente=0, lieve=1, moderata=2, severa=3).
•Manifestazioni oculari (assenti=0, lievi=1, moderate=2, severe=3).
•Cambiamenti fimatosi (assenti=0, lievi=1, moderati=2, severi=3).
5)Cambiamento medio rispetto al Basale nell’eritema facciale non-transitorio a V3, V4 e V5 (assente=0, lieve=1, moderato=2, severo=3).

I seguenti endpoint (6 e 7) saranno valutati utilizzando fotografie standardizzate:
6)Cambiamento medio, rispetto al Basale (V2), del numero di lesioni infiammatorie a V3 e V5, valutato secondo l’analisi delle immagini effettuata da Canfield.
7)Cambiamento medio rispetto al Basale nel punteggio dell’eritema facciale non transitorio a V3, V4 e V5, basato sul rossore globale dell’area frazionata, valutato secondo l’analisi delle immagini effettuata da Canfield.
In aggiunta, anche i seguenti endpoint secondari saranno valutati:
8)Cambiamento medio rispetto al Basale nella scala di auto-stima di base a V4 e V5.
9)Cambiamento medio rispetto al Basale nell’indice di qualità di vita in dermatologia (10-punti DLQI) a V4 e V5.
10)Differenza media nel punteggio del questionario di soddisfazione al trattamento tra i gruppi di trattamento a V4.
Il seguente endpoint secondario esplorativo sarà valutato presso i centri in grado di collezionare e conservare campioni sierici:
11)Cambiamento medio rispetto al Basale dei livelli dei marker infiammatori circolanti a V3, V4 e V5.
Endpoint esplorativo aggiuntivo:
Il seguente endpoint sarà valutato utilizzando fotografie standardizzate:
12)Cambiamento medio rispetto al Basale dell’indice di presentazione della trama cutanea a V3, V4 e V5 valutato secondo l’analisi delle immagini effettuata da Canfield.

E.5.2.1

Timepoint(s) of evaluation of this end point

10, 30 and 60 days from randomization

10, 30 e 60 giorni dalla randomizzazione

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)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

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)

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

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

Ultima visita dell'ultimo paziente

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 months

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:

216

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

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

236

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

Nessuno

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2018-03-02

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-02-16

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

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Orphan Designation Number:
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