Clinical Trials Register

Summary
EudraCT Number:	2015-000790-13
Sponsor's Protocol Code Number:	BIL-0115-MED
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:	2015-05-08
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

Spain - AEMPS

A.2

EudraCT number

2015-000790-13

A.3

Full title of the trial

A single-centre, randomized, double-blind, crossover, single-dose clinical trial to compare bilastine, desloratadine, rupatadine and placebo in the suppression of wheal and flare induced by intradermal histamine in healthy volunteers.

Ensayo clínico unicéntrico, aleatorizado, doble ciego, cruzado, de dosis única de comparación de bilastina, desloratadina, rupatadina y placebo en la supresión de la pápula y eritema inducida por histamina intradérmica en voluntarios sanos.

A.3.1

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

Efficacy compared between bilastine, desloratadine, rupatadine and placebo in reduction of histamine-induced skin reactivity in healthy volunteers.

Eficacia comparada entre bilastina, desloratadina, rupatadina y placebo en la reducción de la reactividad cutánea inducida por histamina en voluntarios sanos.

A.4.1

Sponsor's protocol code number

BIL-0115-MED

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	FAES FARMA, S.A.
B.1.3.4	Country	Spain
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	FAES FARMA, S.A.
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	FAES FARMA, S.A.
B.5.2	Functional name of contact point	Clinical Research Director
B.5.3	Address:
B.5.3.1	Street Address	Avda. Autonomía, 10
B.5.3.2	Town/ city	Leioa / Vizcaya
B.5.3.3	Post code	48940
B.5.3.4	Country	Spain
B.5.4	Telephone number	+34944818300
B.5.5	Fax number	+34944818309
B.5.6	E-mail	ccampo@faes.es

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	BILAXTEN
D.2.1.1.2	Name of the Marketing Authorisation holder	FAES FARMA, 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	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	BILASTINA
D.3.9.1	CAS number	202189-78-4
D.3.9.2	Current sponsor code	F-96221-BM1
D.3.9.3	Other descriptive name	BILASTINA
D.3.9.4	EV Substance Code	SUB37845
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	20
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	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	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	AERIUS
D.2.1.1.2	Name of the Marketing Authorisation holder	MERCK SHARP & DOHME, 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	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	DESLORATADINA
D.3.9.1	CAS number	100643-71-8
D.3.9.3	Other descriptive name	DESLORATADINA
D.3.9.4	EV Substance Code	SUB01596MIG
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	5
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	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	RUPAFIN
D.2.1.1.2	Name of the Marketing Authorisation holder	J. Uriach & Cía 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	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	RUPATADINA
D.3.9.1	CAS number	158876-82-5
D.3.9.3	Other descriptive name	RUPATADINA
D.3.9.4	EV Substance Code	SUB10406MIG
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.3.11 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	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

ALLERGIC RHINOCONJUNTIVITIS AND CHRONIC URTICARIA

RINOCONJUNTIVITIS ALÉRGICA Y URTICARIA CRÓNICA

E.1.1.1

Medical condition in easily understood language

ALLERGIC RHINOCONJUNTIVITIS AND CHRONIC URTICARIA

RINOCONJUNTIVITIS ALÉRGICA Y URTICARIA CRÓNICA

E.1.1.2

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

TO COMPARE THE EFFICACY OF BILASTINE 20 MG, DESLORATADINE 5 MG AND RUPATADINE 10 MG IN THE REDUCTION OF HISTAMINE-INDUCED SKIN REACTIVITY IN HEALTHY VOLUNTEERS.

COMPARAR LA EFICACIA DE BILASTINA 20 MG, DESLORATADINA 5 MG Y RUPATADINA 10 MG EN LA REDUCCIÓN DE LA REACTIVIDAD CUTÁNEA INDUCIDA POR LA ADMINISTRACIÓN INTRADÉRMICA DE HISTAMINA, EN VOLUNTARIOS SANOS.

E.2.2

Secondary objectives of the trial

TO EVALUATE THE SUBJETIVE FEELING OF ITCHING AFTER HISTAMINE INOCULATION AND THE ONSET OF ACTION FOR EVERY TREATMENT VERSUS PLACEBO.
TO EVALUATE THE TOLERABILITY AND SAFETY OF PRODUCTS.

EVALUAR LA SENSACIÓN SUBJETIVA DE PICOR DESPUÉS DE LA INOCULACIÓN DE LA HISTAMINA Y EL MOMENTO DE INICIO DE ACCIÓN PARA CADA TRATAMIENTO COMPARADO CON PLACEBO.
EVALUAR LA TOLERABILIDAD Y SEGURIDAD.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1 Subjects of either gender (male or female) with an age between 18 and 40 years (both included). 2 Body weight within the normal range (BMI between18 and 30 kg/m2. 3 Medical history, physical examination by organs, both within normal limits. 4 No evidence of significant disease (organic or psychiatric) based on anamnesis taking, physical examination and complementary tests. 5 Laboratory tests (complete blood count and chemistry) within the normal ranges according to the normal reference values of the chemistry laboratory of the "Hospital de la Santa Creu i Sant Pau". Variations may be admitted in accordance with the CIM's clinical criterion. 6 Vital signs (systolic and diastolic blood pressure, heart rate and temperature) and ECG record within normal ranges. 7 Child-bearing potential female volunteers must use contraceptive measures other than hormonal contraceptives. 8 Induced wheal area values within the reference range of the Research Institute (55.21 mm2-259.41 mm2), in the histamine skin reaction test performed during the selection. 9 Free will to participate in the study, with written informed consent signed.

1 Sujetos de cada género (hombre o mujer) con edad entre 18 y 40 años (ambos incluidos). 2 Peso corporal dentro de los valores normales (IMC entre 18 y 30 kg/m2). 3 Historia médica, exámen físico de órganos, ambos dentro de los límites normales. 4 No evidencia de enfermedad significante (orgánica y psiquiátrica) basada en la recogida de la anamnesis, exámen físico y test complementarios. 5 Tests de laboratorio (recuento sanguíneo y bioquímica completos) dentro de los rangos normales de acuerdo con los valores normales de referencia del laboratorio bioquímico del "Hospital de la Santa Creu i Sant Pau". Variaciones pueden ser admitidas de acuerdo con el criterio clínico del CIM. 6 Signos vitales (presión sanguínea sistólica y diastólica, pulso y temperatura) y registro de ECG dentro de los valores normales. 7 Mujeres voluntarias con posibilidad de quedarse embarazadas deben usar medidas anticonceptivas distintas de los anticonceptivos hormonales. 8 Valores inducidos del área del habón dentro de los rangos de referencia del Instituto de Investigación (55.21 mm2-259.41 mm2), en la prueba de reacción cutánea con histamina realizada durante la selección. 9 Libre voluntad para participar en el estudio, con el consentimiento informado escrito firmado.

E.4

Principal exclusion criteria

1 Background of allergy, idiosyncrasy or hypersensitivity to drugs. 2 Heavy consumer of stimulating drinks (>5 cups of coffee, tea, chocolate or cola drinks per day). 3 Background of alcoholism or drug dependence in the last one year or daily consumption of alcohol >40 gr/day for men or 24 gr/day for women. 4 Use of any medication within 2 weeks prior to taking the study treatment, (except for the use of paracetamol in short-term symptomatic treatments) including over-the-counter medications and medicinal plants. 5 Positive serology for hepatitis B, C or HIV. 6 Positive results for abuse drugs urine test or ethanol in breath test. 7 Background or clinical evidence of cardiovascular, respiratory, renal, hepatic, endocrine, gastrointestinal, haematological, neurological disease or other chronic diseases. 8 Rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactosemalabsorption. 9 Smokers. 10 Pregnancy or lactation status. 11 To have participated in another clinical trial during the 3 months prior to study starts. 12 To have donated blood in the 4 weeks prior to study starts. 13 To have underground major surgery during the previous 6 months. 14 Positive dermographism.

1 Antecedentes de alergia, idiosincrasia o hiperactividad a las drogas. 2 Elevado consumidor de bebidas estimulantes (> 5 tazas de café, té, chocolate o bebidas de cola al día). 3 Antecedentes de alcoholismo o drogodependiente in el último año o consumidor diario de alcohol 40 gr/día para hombres o 24 gr/día para mujeres. 4 Uso de algún medicamento dentro de las 2 semanas previas a tomar el tratamiento de estudio, (excepto el uso de paracetamol en tratamientos sintomáticos a corto plazo) incluyento medicamentos sin receta y plantas medicinales. 5 Serología positiva para hepatitis B, C o VIH. 6 Resultado positivo por abuso de drogas en la prueba de orina o etanol en la prueba del aliento. 7 Antecedentes o evidencia clínica de enfermedad cardiovascular, respiratoria, renal, hepática, endocrina, gastrointestinal, hematológica, neurológica u otra enfermedad crónica. 8 Problemas hereditarios raros de intolerancia a la galactosa, deficiencia de lactose Lapp o mala absorción glucosa-galactosa. 9 Fumadores. 10 Estado de embarazo o lactancia. 11 Haber participado en otro ensayo clínico durante los 3 meses antes de empezar el estudio. 12 Haber donado sangre en las 4 semanas previas al comienzo del estudio. 13 Haber tenido una cirujía mayor en los últimos 6 meses. 14 Dermografismo positivo.

E.5 End points

E.5.1

Primary end point(s)

The porcentage (%) of reduction of the wheal and flare areas obtained after study drug administrations in comparison to their corresponding baseline values in cm3.
The following formula will be used:
% reduction=[(postdose value - baseline value) x 100] / baseline value

El porcentaje (%) de la reducción del área de la pápula y eritema obtenido después de la administración del fármaco en el estudio en comparación con sus valores basales correspondientes en cm3.
Se usárá la siguiente fórmula:
% reducción=[(valor postdosis - valor basal) x 100] / valor basal

E.5.1.1

Timepoint(s) of evaluation of this end point

From the administration of the treatment up to 24 hour after, each one of the formulations.

Desde la administración del tratamiento hasta 24 horas después, con cada una de las formulaciones.

E.5.2

Secondary end point(s)

Maximum inhibition time: time (h) in which the maximum wheal and flare inhibition is reached.
Itching sensation: changes (mm) in the VAS respect to the corresponding baseline values.
Onset of action: for every treatment versus placebo, defined as the first time point where the difference in wheal surface is statistically significant compared to placebo.
Incidence of adverse events for each treatment.
Changes in the tolerability parameters (laboratory tests, vital signs, ECG parameters) evaluated in terms of clinical relevance.

Tiempo de máxima inhibición: tiempo (h) en alcanzar la mayor inhibición de la pápula y eritema.
Sensación de picor: cambios (mm) en el VAS respecto a los valores basales correspondientes.
Comienzo de acción: definido como el primer punto en que la diferencia en la superficie del habón para cada tratamiento es estadísticamente significativa comparada con placebo.
Incidencia de eventos adversos para todos los tratamientos.
Cambios en los parámetros de tolerabilidad (pruebas de laboratorio, constantes vitales, parámetros de ECG) evaluados en términos de relevancia clínica.

E.5.2.1

Timepoint(s) of evaluation of this end point

Maximal time inhibition and onset of action will be determinated during the measures of the skin reactivity in differents times described in the protocol, during each one of the formulations.
Itching sensation will be evaluated in differents times described in the protocol, during each one of the formulations.
Tolerability parameters: laboratory tests and ECG parameters will be evaluated during the inclusion phase and at the end of study; vital signs will be evaluated during the inclusion phase, baseline (premedication), +1 hour, +2 hours, +4 hours, +6 hours, +9 hours, +12 hours, y +24 hours post-doses, after each one of the formulations.
Incidence of adverse event will be recorded during all the clinical trial.

Tiempo de máxima inhibición y comienzo de acción serán determinados durante las medidas de la reactividad en la piel en diferentes tiempo, descritos en el protocolo y durante cada una de las formulaciones.
La sensación de picor será evaluada en diferentes tiempo, descritos en el protocolo y durante cada una de las formulaciones.
Parámetros de tolerabilidad: parámetros de laboratorio y ECG serán evaluados durante el periodo de inclusión y al final del estudio; signos vitales serán evaluados durante el periodo de inclusión, momento basal (premedicación), +30 minutos, +1 hora, +2 horas, +4 horas, +6 horas, +9 horas, +12 horas, y +24 horas post-dosis, después con cada una de las formulaciones.
La incidencia de eventos adversos será registrada durante todo el ensayo clínico.

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

E.8.1.6

Cross over

Yes

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

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

The end of study is established at +24h after the last study drug administration (fourth treatment period).

El final del estudio está establecido en las 24 horas después de la última administración del fármaco de estudio (cuarto periodo de tratamiento).

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:

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

Yes

F.3.2

Patients

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

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)

It is not applicable as it is a study in healthy volunteers to compare the efficacy of four treatments (three anti-histaminics and placebo).

No es necesario, es un estudio en voluntarios sanos para comparar la eficacia de 4 tratamientos (tres anti-histamínicos y placebo).

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

2015-06-10

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-05-13

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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