Clinical Trials Register

Summary
EudraCT Number:	2018-001402-28
Sponsor's Protocol Code Number:	EII_Prep
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2019-01-18
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

Spain - AEMPS

A.2

EudraCT number

2018-001402-28

A.3

Full title of the trial

PROTOCOL FOR THE OPTIMIZATION OF THE PREPARATION FOR THE COLONOSCOPY IN PATIENTS WITH INTESTINAL INFLAMMATORY DISEASE

PROTOCOLO PARA LA OPTIMIZACIÓN DE LA PREPARACIÓN PARA LA COLONOSCOPIA EN PACIENTES CON ENFERMEDAD INFLAMATORIA INTESTINAL

A.3.1

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

PREPARATION FOR THE COLONOSCOPY IN PATIENTS WITH INTESTINAL INFLAMMATORY DISEASE

PREPARACIÓN PARA LA COLONOSCOPI EN PACIENTES CON ENFERMEDAD INFLAMATORIA INTESTINAL

A.4.1

Sponsor's protocol code number

EII_Prep

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	Hospital Universitario La Paz
B.1.3.4	Country	Spain
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	Servicio de Gastroenterología
B.4.2	Country	Spain
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Hospital La Paz. UCICEC
B.5.2	Functional name of contact point	Elena
B.5.3	Address:
B.5.3.1	Street Address	Paseo de la Castellana 261.
B.5.3.2	Town/ city	madrid
B.5.3.3	Post code	28046
B.5.3.4	Country	Spain
B.5.4	Telephone number	34912071466
B.5.5	Fax number	34912071466
B.5.6	E-mail	ebermejo.ucicec@gmail.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	Moviprep Sabor Naranja
D.2.1.1.2	Name of the Marketing Authorisation holder	NORGINE B.V
D.2.1.2	Country which granted the Marketing Authorisation	Spain
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Powder for oral solution
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	MACROGOL 3350
D.3.9.1	CAS number	25322-68-3
D.3.9.3	Other descriptive name	MACROGOL 3350
D.3.9.4	EV Substance Code	SUB20628
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	SODIUM SULFATE ANHYDROUS
D.3.9.1	CAS number	7757-82-6
D.3.9.3	Other descriptive name	SODIUM SULFATE ANHYDROUS
D.3.9.4	EV Substance Code	SUB15326MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	7.500
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	SODIUM CHLORIDE
D.3.9.3	Other descriptive name	SODIUM CHLORIDE
D.3.9.4	EV Substance Code	SUB12581MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	2.691
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	POTASSIUM CHLORIDE
D.3.9.3	Other descriptive name	POTASSIUM CHLORIDE
D.3.9.4	EV Substance Code	SUB12559MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	1.015
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ASCORBIC ACID
D.3.9.3	Other descriptive name	ASCORBIC ACID
D.3.9.4	EV Substance Code	SUB05579MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	4.700
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	SODIUM ASCORBATE
D.3.9.1	CAS number	134-03-2
D.3.9.3	Other descriptive name	SODIUM ASCORBATE
D.3.9.4	EV Substance Code	SUB10549MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	5.900
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	SODIUM
D.3.9.3	Other descriptive name	SODIUM
D.3.9.4	EV Substance Code	SUB15265MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mmol/l millimole(s)/litre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	181.6
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	SULFATE
D.3.9.1	CAS number	14808-79-8
D.3.9.3	Other descriptive name	SULFATE
D.3.9.4	EV Substance Code	SUB22774
D.3.10	Strength
D.3.10.1	Concentration unit	mmol/l millimole(s)/litre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	52.8
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	CHLORIDE ION
D.3.9.3	Other descriptive name	CHLORIDE ION
D.3.9.4	EV Substance Code	SUB32047
D.3.10	Strength
D.3.10.1	Concentration unit	mol/l mole(s)/litre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	59.8
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	POTASSIUM
D.3.9.3	Other descriptive name	POTASSIUM
D.3.9.4	EV Substance Code	SUB14961MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mol/l mole(s)/litre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	14.2
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	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	CitraFleet Polvo
D.2.1.1.2	Name of the Marketing Authorisation holder	Casen Recordati, S.L.,
D.2.1.2	Country which granted the Marketing Authorisation	Spain
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Powder for oral solution
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	SODIUM PICOSULFATE
D.3.9.1	CAS number	10040-45-6
D.3.9.4	EV Substance Code	SUB10569MIG
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	10
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	CITRIC ACID ANHYDROUS
D.3.9.3	Other descriptive name	CITRIC ACID ANHYDROUS
D.3.9.4	EV Substance Code	SUB29050
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10.97
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	MAGNESIUM OXIDE, LIGHT
D.3.9.1	CAS number	546-93-0
D.3.9.3	Other descriptive name	MAGNESIUM OXIDE, LIGHT
D.3.9.4	EV Substance Code	SUB12130MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	3.5
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	POTASSIUM
D.3.9.3	Other descriptive name	POTASSIUM
D.3.9.4	EV Substance Code	SUB14961MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mmol millimole(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	29.4
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 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	Pleinvue polvo
D.2.1.1.2	Name of the Marketing Authorisation holder	Norgine BV
D.2.1.2	Country which granted the Marketing Authorisation	Spain
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Powder for oral solution
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	MACROGOL 3350
D.3.9.3	Other descriptive name	MACROGOL 3350
D.3.9.4	EV Substance Code	SUB20628
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	140
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	SODIUM SULFATE ANHYDROUS
D.3.9.1	CAS number	7757-82-6
D.3.9.3	Other descriptive name	SODIUM SULFATE ANHYDROUS
D.3.9.4	EV Substance Code	SUB15326MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	9
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	SODIUM CHLORIDE
D.3.9.3	Other descriptive name	SODIUM CHLORIDE
D.3.9.4	EV Substance Code	SUB12581MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	5.2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	POTASSIUM CHLORIDE
D.3.9.3	Other descriptive name	POTASSIUM CHLORIDE
D.3.9.4	EV Substance Code	SUB12559MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	2.2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	SODIUM
D.3.9.3	Other descriptive name	SODIUM
D.3.9.4	EV Substance Code	SUB15265MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mmol millimole(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	458.5
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	SULFATE
D.3.9.1	CAS number	14808-79-8
D.3.9.3	Other descriptive name	SULFATE
D.3.9.4	EV Substance Code	SUB22774
D.3.10	Strength
D.3.10.1	Concentration unit	mol mole(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	63.4
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	CHLORIDE ION
D.3.9.3	Other descriptive name	CHLORIDE ION
D.3.9.4	EV Substance Code	SUB32047
D.3.10	Strength
D.3.10.1	Concentration unit	mmol millimole(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	126.6
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	POTASSIUM
D.3.9.3	Other descriptive name	POTASSIUM
D.3.9.4	EV Substance Code	SUB14961MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mmol millimole(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	29.4
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	SODIUM ASCORBATE
D.3.9.1	CAS number	134-03-2
D.3.9.4	EV Substance Code	SUB10549MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	48.11
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ASCORBIC ACID
D.3.9.3	Other descriptive name	ASCORBIC ACID
D.3.9.4	EV Substance Code	SUB05579MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	7.54
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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

preparation in patients with inflammatory bowel disease who will undergo an endoscopy

preparación en pacientes con enfermedad inflamatoria intestinal que van a ser sometidos a una endoscopia

E.1.1.1

Medical condition in easily understood language

preparation in patients with inflammatory bowel disease who will undergo endoscopy

preparación en pacientes con enfermedad inflamatoria intestinal que van a ser sometidos a una endoscopia

E.1.1.2

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

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 evaluate the degree of preparation with Movipreep vs Citrafleet in fractionated doses in patients with IBD.

Evaluar el grado de preparación con Movipreep vs Citrafleet en dosis fraccionada en pacientes con EII.

E.2.2

Secondary objectives of the trial

1. To assess the tolerability and safety of the fractionated dose preparation with Moviprep vs Citrafleet in our center in patients with IBD.
2. Evaluate the satisfaction of the patient with IBD with Moviprep vs Citrafleet in a fractionated dose.

1.valuar la tolerabilidad y la seguridad de la preparación en dosis fraccionada con Moviprep vs Citrafleet en nuestro centro en pacientes con EII.
2.Evaluar la satisfacción del paciente con EII con Moviprep vs Citrafleet en dosis fraccionada.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Patients between 18 and 90 years old.
- Patients with established diagnosis of Inflammatory Bowel Disease to whom a complete colonoscopy is requested for diagnostic purposes.

- Pacientes entre 18 y 90 años.
- Pacientes con diagnostico establecido de Enfermedad Inflamatoria Intestinal a quienes se solicite una colonoscopia completa con fines diagnósticos.

E.4

Principal exclusion criteria

- Pregnant women.
- Previous colonic resection surgeries.
- Endoscopies performed for therapeutic purposes (eg, polyps resection already objectified in previous studies).
- Poor preparation in recent endoscopy (12 months prior).
- Patients not trained to understand the nature of the study, the procedures to follow or who is not authorized to sign an informed consent.

- Mujeres embarazadas.
- Cirugías resectivas colónicas previas.
- Endoscopias realizadas con fines terapéuticos (ej: resección pólipos ya objetivados en estudios previos).
- Mala preparación en endoscopia reciente (12 meses previos).
- Pacientes no capacitados para entender la naturaleza del estudio, los procedimientos a seguir o que no este habilitado para firmar un consentimiento informado.

E.5 End points

E.5.1

Primary end point(s)

Boston scale. ANNEX III.

Escala de Boston. ANEXO III.

E.5.1.1

Timepoint(s) of evaluation of this end point

at the end of endoscopy

Al finalizar la endoscopia

E.5.2

Secondary end point(s)

- Patient Satisfaction Questionnaire prior to the test and if the preparation has been completed completely
- Analytical with hydroelectrolytic parameters
- Questionnaire per week of late complications.

- Cuestionario de satisfacción del paciente previo a la prueba y si ha conseguido realizar la preparación completamente
- Analítica con parámetros hidroelectrolíticos
- Cuestionario a la semana de complicaciones tardías.

E.5.2.1

Timepoint(s) of evaluation of this end point

before the completion of the endoscopy and a week later

antes de la realización de la endoscopia y una semana después

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

Yes

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

E.8.1.3

Single blind

Yes

E.8.1.4

Double blind

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

Yes

E.8.4

The trial involves multiple sites in the 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

LVLP

Ultima visita del ultimo paciente

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

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:

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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2019-01-18.

Yes

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.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

ninguno

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

2019-01-28

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-01-24

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

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IMP with orphan designation in the indication
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