Clinical Trials Register

Summary
EudraCT Number:	2011-000337-36
Sponsor's Protocol Code Number:	FSJD-GLUCOBR-2010
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2011-07-04
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

2011-000337-36

A.3

Full title of the trial

IMPACT OF THE ADMINISTRATION OF SYSTEMIC GLUCOCORTICOIDS ON INFLAMMATORY RESPONSE AND CLINICAL EVOLUTION OF PATIENTS DIAGNOSED WITH MODERATE-SEVERE BRONCHIOLITIS

IMPACTO DE LA ADMINISTRACIÓN DE GLUCOCORTICOIDES SISTÉMICOS EN LA RESPUESTA INFLAMATORIA Y EVOLUCIÓN CLÍNICA DE LOS PACIENTES DIAGNOSTICADOS DE BRONQUIOLITIS MODERADA-GRAVE

A.3.1

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

IMPACT OF THE ADMINISTRATION OF SYSTEMIC GLUCOCORTICOIDS ON INFLAMMATORY RESPONSE AND CLINICAL EVOLUTION OF PATIENTS DIAGNOSED WITH MODERATE-SEVERE BRONCHIOLITIS

IMPACTO DE LA ADMINISTRACIÓN DE GLUCOCORTICOIDES SISTÉMICOS EN LA RESPUESTA INFLAMATORIA Y EVOLUCIÓN CLÍNICA DE LOS PACIENTES DIAGNOSTICADOS DE BRONQUIOLITIS MODERADA-GRAVE

A.3.2

Name or abbreviated title of the trial where available

N/A

A.4.1

Sponsor's protocol code number

FSJD-GLUCOBR-2010

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	FUNDACIÓ SANT JOAN DE DÉU
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	Fondo del Ministerio de Sanidad y Política Social
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	FUNDACIÓ SANT JOAN DE DÉU
B.5.2	Functional name of contact point	FUNDACIÓ SANT JOAN DE DÉU
B.5.3	Address:
B.5.3.1	Street Address	C/ Santa Rosa 39-57, 3ª Planta Edificio Docente
B.5.3.2	Town/ city	Esplugues de Llobregat (Barcelona)
B.5.3.3	Post code	08950
B.5.3.4	Country	Spain
B.5.4	Telephone number	+34936009751
B.5.5	Fax number	+34936009771
B.5.6	E-mail	rmorales@fsjd.org

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	SOLU-MODERIN 40 mg
D.2.1.1.2	Name of the Marketing Authorisation holder	PFIZER. S.A.
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 solution for injection/infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	2375-03-3
D.3.9.3	Other descriptive name	METHYLPREDNISOLONE SODIUM SUCCINATE
D.3.9.4	EV Substance Code	SUB14562MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/g milligram(s)/gram
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	40
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	ESTILSONA Gotas
D.2.1.1.2	Name of the Marketing Authorisation holder	LABORATORIOS SONPHAR, 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	Oral drops
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	PREDNISOLONE STEAGLATE
D.3.9.1	CAS number	5060-55-9
D.3.9.4	EV Substance Code	SUB10019MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	13.3
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	SOLU-MODERIN 125 mg
D.2.1.1.2	Name of the Marketing Authorisation holder	PFIZER. S.A.
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 solution for injection/infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	2375-03-3
D.3.9.3	Other descriptive name	METHYLPREDNISOLONE SODIUM SUCCINATE
D.3.9.4	EV Substance Code	SUB14562MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/g milligram(s)/gram
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	125
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: 4
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	SOLU-MODERIN 500 mg
D.2.1.1.2	Name of the Marketing Authorisation holder	PFIZER. S.A.
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 solution for injection/infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	2375-03-3
D.3.9.3	Other descriptive name	METHYLPREDNISOLONE SODIUM SUCCINATE
D.3.9.4	EV Substance Code	SUB14562MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/g milligram(s)/gram
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	500
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	Solution for injection/infusion
D.8.4	Route of administration of the placebo	Intravenous use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Oral drops
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

Viral bronchiolitis

Bronquiolitis viral

E.1.1.1

Medical condition in easily understood language

Respiratory viral infection.

Infección respiratoria por virus.

E.1.1.2

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.0
E.1.2	Level	PT
E.1.2	Classification code	10038718
E.1.2	Term	Respiratory syncytial virus bronchiolitis
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

a) To determine whether a 7-day course of systemic glucocorticoids reduces the inflammatory activity in paediatric patients under one year-old diagnosed with moderate or severe bronchioloitis compared to a control group.
b) To assess the morbidity in relation to clinical evolution (need for admission in the PICU-CCM, for mechanical ventilation, inotropes, nosocomial infection, rescue therapies for respiratory insufficiency; number of days in PICU and hospital stay; and death), in the treatment and control groups.

a) Valorar si un curso de glucocorticoides sistémicos, de 7 días de duración, reduce la actividad inflamatoria en los pacientes pediátricos, menores de un año de edad, diagnosticados de bronquiolitis moderada o grave, en relación al grupo control.
b) Evaluar la morbilidad, en cuanto a los datos de evolución clínica (necesidad de ingreso en UCIP-SMC, de ventilación mecánica, de inotrópicos, de infección nosocomial, de terapias de rescate de la insuficiencia respiratoria; días de ingreso en UCIP y de hospitalización; y éxitus), en los grupos de tratamiento y control.

E.2.2

Secondary objectives of the trial

a) To study differences in inflammatory response and clinical evolution of patients diagnosed with moderate-severe bronchiolitis in relation to the causal pathogen.
b) To study differences in the clinical evolution of patients diagnosed with moderate-severe bronchiolitis in relation to the causal pathogen between those receiving low doses of methylprednisolone/prednisolone and the control group.
c) To study if the inflammatory response is different in patients requiring admission to the Intensive Care Unit than those who do not.
d) To determine the side effects of the glucocorticoids.

a) Analizar si existen diferencias en la respuesta inflamatoria y la evolución clínica de los pacientes diagnosticados de bronquiolitis moderada o grave, en función del patógeno causal.
b) Analizar si existen diferencias en la evolución clínica de los pacientes diagnosticados de bronquiolitis moderada o grave, según el patógeno causal, entre los que reciben dosis bajas de metilprednisolona/prednisolona y el grupo control.
c) Analizar si la respuesta inflamatoria es diferente en los pacientes que precisan ingreso en la unidad de cuidados intensivos y los que no.
d) Determinar los efectos secundarios de los corticoides.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

The study will recruit paediatric patients under one year old who require hospitalization for moderate-severe bronchiolitis according to the HSJD BRONCHIOLITIS SCORE of Sant Joan de Deu Hospital (Annex 1).

Se incluirán pacientes pediátricos menores de un año de edad que requieran ingreso en hospitalización por bronquiolitis moderada o grave según puntuación del SCORE HSJD BRONQUIOLITIS de Sant Joan de Déu (Anexo 1).

E.4

Principal exclusion criteria

a) Patients of either gender under one year old with mild bronchiolitis.
b) Patients with bronchiolitis in which the principal symptom is apnoea.
c) Patients who have received corticotherapy before admission to hospital.
d) No consent from parents or tutors.
e) Patients with previous acquired or innate immunodepression.
f) Patients enrolled in other clinical trials.

a) Pacientes de cualquier edad y sexo menores de un año diagnosticados de bronquiolitis leve.
b) Pacientes con bronquiolitis que presenten apneas como clínica principal.
c) Pacientes con corticoterapia previa al ingreso en el hospital.
d) No consentimiento de los padres o tutores.
e) Pacientes con inmunodepresión previa adquirida o innata.
f) Pacientes incluidos en otros ensayos clínicos.

E.5 End points

E.5.1

Primary end point(s)

The existence of differences in inflammatory response and clinical evolution of patients with moderate-severe bronchiolitis treated with methylprednisolone/prednisolone compared to those receiving placebo.
Other key clinical variables studied include:
Risk factors of severe bronchiolitis: prematurity, heart disease, previous respiratory condition, immune deficiency.
Variables requiring clinical monitoring

Heart rate (HR), Breathing rate (BR), blood pressure (BP), Daily HSJD BRONCHIOLITIS score (Annex 1).

Analytical variables

? Inflammatory stimulants (IL-12, IFN-? and IL-2), inflammatory inhibitors (IL-4, IL-10), lymphocytic parameters (LT, LB, LT4 and LT8) and total Ig with Ig E. The values of interleukins and IFN-? will be determined by ELISA using commercially available reagents. White blood cell populations will be determined by flow cytometry.
? Full blood count and basic biochemical tests, reactive-C protein and procalcitonin. The blood count parameters, basic biochemistry, reactive-C protein and procalcitonin will be determined by the standard commercially available kits.

Three mL of blood will be extracted for each test, one extraction will be carried out in the baseline visit and another after 5-7 days of treatment.

Clinical evolution-complications

Need for admission to the PICU-CCM, requirement of inotropes, requirement of invasive or non-invasive mechanical ventilation, the need for other respiratory rescue treatments (nitric oxide, high frequency ventilation, extracorporeal membrane oxygenation), the need for extrarenal purification. Community or nosocomial bacterial superinfection (according to criteria of the Center of Disease Control ?CDC- Annex 9)(34). Presence of criteria of multiorgan failure (The ACCP/SCCM Consensus Conference Committee. American College of Chest Physicians/Society of Critical Care Medicine, Annex 10)(35). Days of admission to the PICU and days of hospital stay. Death.

Existencia de diferencias en la respuesta inflamatoria y la evolución clínica de los pacientes con bronquiolitis moderada-grave tratados con metilprednisolona/prednisolona respecto a los que reciben placebo.
Se consideran también variables principales:
Factores de riesgo de bronquiolitis grave: prematuridad, cardiopatía, patología respiratoria previa, inmunodeficiencia.
Variables de monitorización clínica

Frecuencia cardiaca (FC) frecuencia respiratoria (FR), tensión arterial (TA), SCORE HSJD BRONQUIOLITIS diario (Anexo 1).

Variables analíticas

? Factores estimuladores de la reacción inflamatoria (IL-12, IFN-? e IL-2), factores inhibidores de la reacción inflamatoria (IL-4, IL-10), parámetros linfocitarios (LT, LB, LT4 y LT8) e Ig totales con Ig E. Los valores de interleukinas y IFN-? se determinarán por ELISA utilizando reactivos comerciales. Las poblaciones linfocitarias se determinarán por citometría de flujo.
? Hemograma y bioquímica básica, proteína C reactiva y la procalcitonia. Los parámetros del hemograma, y bioquímica básica así como la proteína C reactiva y la procalcitonia se determinarán mediante los kits comerciales habituales.

El volumen de sangre a extraer será de 3ml por cada determinación. Se realizan dos determinaciones, una en la visita basal y otra entre los 5-7 días de tratamiento.

Evolución clínica-Complicaciones

Necesidad de ingreso en UCIP-SMC, necesidad de inotrópicos, necesidad de ventilación mecánica invasiva o no invasiva, necesidad de otros tratamientos de rescate respiratorio (óxido nítrico, ventilación alta frecuencia, oxigenación por membrana extracorpórea), necesidad de depuración extrarrenal. Sobreinfección bacteriana comunitaria o nosocomial (según criterios del Center of Disease Control ?CDC- Anexo 9)(34). Presencia de criterios de fallo multiorgánico (The ACCP/SCCM Consensus Conference Committee. American College of Chest Physicians/Society of Critical Care Medicine, Anexo 10)(35). Días de ingreso en UCIP y días de ingreso hospitalario. Exitus.

E.5.1.1

Timepoint(s) of evaluation of this end point

The principal variable will be studied with the data recorded from the tests and questionnaires carried out on the patients during the study (baseline visit and treatment).

Se analizará la variable principal con los datos que se recojan en los controles y cuestionarios que se realizan a los pacientes a lo largo del estudio. (Visita basal y tratamiento)

E.5.2

Secondary end point(s)

The following secondary variables will be recorded:

Demographic data

Age, weight, gender. Day of admission to hospital.

Protection factors

Previous immunization with Palivizumab®.

Severity factors on admission

Paediatric risk score mortality (PRISM) III on admission (Annex 7), clinical severity of bronchiolitis according to the HSJD BRONCHIOLITIS SCORE (Annex 1) and radiographic pattern (interstitial, alveolar, mixed, ADRS).

Etiological agent

RSV-A, RSV-B, influenza A, Influenza B, influenza A/H1N1, adenovirus, metapneumovirus, rhinovirus, par influenza virus 1-4, enterovirus. The virus will be analyzed by PCR in a sample of nasopharyngeal aspirate. Respiratory viruses will be determined by the Luminex Xtag respiratory viral test.

Se recogerán las siguientes variables secundarias:

Datos demográficos

Edad, peso, sexo. Día de ingreso en hospitalización.

Factores de protección

Inmunización previa con Palivizumab®.

Factores de gravedad al ingreso

Pediatric risk score mortality (PRISM) III al ingreso (Anexo 7), gravedad clínica de la bronquiolitis según SCORE HSJD BRONQUIOLITIS (Anexo 1) y patrón radiográfico (intersticial, alveolar, mixto, SDRA).

Agente etiológico

VRS-A, VRS-B, influenza A, Influenza B, influenza A/H1N1, adenovirus, metaneumovirus, rinovirus, virus parainfluenza 1-4, enterovirus. El de virus se realizará mediante técnica de PCR en muestra de aspirado nasofaríngeo. Los virus respiratorios se determinarán mediante Xtag respiratory virus de Luminex.

E.5.2.1

Timepoint(s) of evaluation of this end point

Secondary variables will be studied during the study, mainly in the baseline visit.

Se analizará las variables secundarias a lo largo del estudio fundamentalmente en la visita basal.

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

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

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

Last patient last visit will be the end of the trial

El final del ensayo coincide con la última visita del último sujeto
reclutado en el ensayo.

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

Yes

F.1.1

Number of subjects for this age range:

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)

Yes

F.1.1.4.1

Number of subjects for this age range:

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

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

Yes

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

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

Infants and toddlers less than one year old

Niños en fase de Lactancia menores de un año de edad

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)

Not applicable

No aplica

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

2011-08-30

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-07-29

P. End of Trial
P.	End of Trial Status	Completed

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