Clinical Trials Register

Summary
EudraCT Number:	2019-003024-20
Sponsor's Protocol Code Number:	HEMP-0119/ES
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2019-08-09
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

2019-003024-20

A.3

Full title of the trial

Multicenter, double-blind, randomized clinical trial to evaluate and compare the efficacy and safety of Hemorrane® Plus (Hemorrane® + benzocaine) with Hemorrane® and with placebo in patients with grade I and II hemorrhoids.

Ensayo clínico multicéntrico, doble ciego, randomizado, para evaluar y comparar la eficacia y seguridad de Hemorrane® Plus (Hemorrane®+benzocaína) con Hemorrane® y con placebo en pacientes con hemorroides de grado I y II.

A.3.1

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

Clinical trial to evaluate and compare the efficacy and safety of Hemorrane® Plus

Ensayo clínico para evaluar y comparar la eficacia y seguridad de Hemorrane® Plus

A.4.1

Sponsor's protocol code number

HEMP-0119/ES

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 SA
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 SA
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 SA
B.5.2	Functional name of contact point	Nieves Fernández
B.5.3	Address:
B.5.3.1	Street Address	Av. Autonomia, 10
B.5.3.2	Town/ city	Leioa
B.5.3.3	Post code	48940
B.5.3.4	Country	Spain
B.5.4	Telephone number	34944818300
B.5.6	E-mail	nfernandez@faes.es

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	HEMORRANE PLUS
D.3.4	Pharmaceutical form	Rectal cream
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Rectal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	HYDROCORTISONE
D.3.9.2	Current sponsor code	Hemorrane Plus
D.3.9.4	EV Substance Code	SUB02562MIG
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	BENZOCAINE
D.3.9.2	Current sponsor code	benzocaine
D.3.9.4	EV Substance Code	SUB05755MIG
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	30
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	HEMORRANE
D.2.1.1.2	Name of the Marketing Authorisation holder	FAES FARMA
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.3.1	Product name	HEMMORRANE
D.3.4	Pharmaceutical form	Rectal cream
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Rectal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	HYDROCORTISONE ACETATE
D.3.9.2	Current sponsor code	HEMORRANE
D.3.9.4	EV Substance Code	SUB02562MIG
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	Rectal cream
D.8.4	Route of administration of the placebo	Rectal use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Bleeding grade I hemorrhoids

Hemorroides de grado I sangrantes

E.1.1.1

Medical condition in easily understood language

HEMORRANES

HEMORROIDES

E.1.1.2

Therapeutic area

Not possible to specify

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

Evaluar y comparar la eficacia sobre el dolor* con Hemorrane® Plus (Hemorrane®+benzocaína), Hemorrane® y placebo en pacientes con hemorroides de grado I y II, valorado por el paciente.

To evaluate and compare the efficacy on pain * with Hemorrane® Plus (Hemorrane® + benzocaine), Hemorrane® and placebo in patients with grade I and II hemorrhoids, assessed by the patient.

E.2.2

Secondary objectives of the trial

1. Evaluate and compare the speed of action on local pain relief * from Hemorrane® Plus (Hemorrane® + benzocaine), Hemorrane® and placebo in patients with grade I and II hemorrhoids.
2. Evaluate and compare the efficacy of Hemorrane® Plus (Hemorrane® + benzocaine), Hemorrane® and placebo on local relief of pruritus, burning-stinging and bleeding assessed by the patient.
3. Evaluate and compare the efficacy of Hemorrane® Plus (Hemorrane® + benzocaine), Hemorrane® and placebo on local inflammation assessed by the researcher.
4. Evaluate and compare the efficacy of Hemorrane® Plus (Hemorrane® + benzocaine), Hemorrane® and placebo on the quality of life assessed by the patient.
5. Evaluate the safety of Hemorrane® Plus (Hemorrane® + benzocaine), Hemorrane® and placebo.

1. Evaluar y comparar la rapidez de acción sobre el alivio local del dolor* de Hemorrane® Plus (Hemorrane®+benzocaína), Hemorrane® y placebo en pacientes con hemorroides de grado I y II.
2. Evaluar y comparar la eficacia de Hemorrane® Plus (Hemorrane®+benzocaína), Hemorrane® y placebo sobre el alivio local del prurito, del escozor-ardor y del sangrado valorada por el paciente.
3. Evaluar y comparar la eficacia de Hemorrane® Plus (Hemorrane®+benzocaína), Hemorrane® y placebo sobre la inflamación local valorada por el investigador.
4. Evaluar y comparar la eficacia de Hemorrane® Plus (Hemorrane®+benzocaína), Hemorrane® y placebo sobre la calidad de vida valorada por el paciente.
5. Evaluar la seguridad de Hemorrane® Plus (Hemorrane®+benzocaína), Hemorrane® y placebo.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Age: over 18 years.
2. Sex: both sexes.
3. Patients with grade I and II hemorrhoids.
4. Patients with pain assessed according to Visual Analogue Scale ≥ 5 points.
5. Patients with pruritus and burning-sting evaluated according to Visual Analogue Scale ≥ 5 points.
6. The patient must commit to comply with the hygienic-dietary measures established for the general management of hemorrhoids.
7. Urinary test of negative pregnancy in women.
8. Patients with adequate level for understanding the study.
9. The patient must have voluntarily signed the Informed Consent

1. Edad: mayores de 18 años.
2. Sexo: ambos sexos.
3. Pacientes con hemorroides de grado I y II.
4. Pacientes con dolor evaluado según Escala Visual Analógica ≥ 5 puntos.
5. Pacientes con prurito y escozor-ardor evaluado según Escala Visual Analógica ≥ 5 puntos.
6. El paciente se debe comprometer a cumplir con las medidas higiénico-dietéticas establecidas para el manejo general de las hemorroides.
7. Prueba urinaria de embarazo negativa en mujeres.
8. Pacientes con adecuado nivel para la comprensión del estudio.
9. El paciente debe haber firmado voluntariamente el Consentimiento Informado

E.4

Principal exclusion criteria

1. Subjects who have used other topical antihemorrhoids or other topical agents applicable in the same anorectal area for at least one week before the start of the study (Visit 1, day 1), nor their use throughout the study
2. Hemorrhoidal surgical intervention that is scheduled from Visit 1 (day 1) to the follow-up visit Visit 3 (day 15).
3. Severe liver disease (Child-Pugh C).
4. Severe or terminal renal failure documented in the patient's medical history.
5. Moderate to severe cardiovascular disease documented in the patient's medical history.
6. History of hypersensitivity to any of the active ingredients or components of the products under investigation.
7. Active hemorrhoidal hemorrhage or for any other cause.
8. Patients with other pathologies with symptoms similar to hemorrhoidal disease, and patients with more serious pathologies that may cause rectorrhagia.
9. Patients with bacterial, viral and / or fungal infections of the perianal region. 10. Have the diagnostic test for pancreatic puncture with bentiromide scheduled from Visit 1 (day 1) to the follow-up visit Visit 3 (day 15).
11. Be on treatment with any of the prohibited concomitant medications (sulfonamides, cholinesterase inhibitors, local ester anesthetics) for at least one week before the start of the study (Visit 1, day 1), or its use throughout the study.
12. Any other medical and / or therapeutic circumstance considered by the researcher that prevents adequate follow-up and / or adequate evolution of the response to the study treatments.
13. Pregnant women or positive pregnancy test, and lactating women.
14. Women of childbearing age who do not undertake to take the pregnancy test and use valid contraceptive methods during the study and up to one week after the end of the study. The following are considered valid contraceptive methods: barrier method (diaphragm, condom), intrauterine device (IUD), vasectomized couple, sexual abstinence, hormonal contraceptives, intrauterine system (SIU), bilateral tubal occlusion.
15. HIV positive patients known in the last five years.
16. Patients with active cancer process in the last five years.
17. Patients who have received an investigational drug (including vaccines) or have used an invasive medical device under investigation in the last 30 days prior to the start of the selection phase or are currently participating in another clinical trial.

1. Sujetos que hayan utilizado otros antihemorroidales tópicos ni otros agentes tópicos aplicables en la misma zona anorectal desde al menos una semana antes del inicio del estudio (Visita 1, día 1), ni su uso a lo largo del estudio.
2. Intervención quirúrgica hemorroidal que esté programada desde la Visita 1 (día 1) hasta la visita de seguimiento Visita 3 (día 15).
3. Enfermedad he
pática grave (Child- Pugh C).
4. Insuficiencia renal grave o terminal documentada en la historia clínica del paciente.
5. Enfermedad cardiovascular moderada a grave documentada en la historia clínica del paciente.
6. Antecedentes de hipersensibilidad a alguno de los principios activos o componentes de los productos en investigación.
7. Hemorragia activa hemorroidal o por cualquier otra causa.
8. Pacientes con otras patologías con sintomatología similar a la enfermedad hemorroidal, y pacientes con patologías más graves que puedan producir rectorragia.
9. Pacientes con infecciones bacterianas, víricas y/o fúngicas de la región perianal.10. Tener programada la prueba diagnóstica de punción pancreática con bentiromida desde la Visita 1 (día 1) hasta la visita de seguimiento Visita 3 (día 15).
11. Estar en tratamiento con alguna de las medicaciones concomitantes prohibidas (sulfamidas, inhibidores de la colinesterasa, anestésicos locales tipo éster) desde al menos una semana antes de inicio del estudio (Visita 1, día 1), ni su uso a lo largo del estudio.
12. Cualquier otra circunstancia médica y/o terapéutica considerada por el investigador que impida un seguimiento adecuado y/o evolución adecuada de la respuesta a los tratamientos del estudio.
13. Mujeres embarazadas o prueba de embarazo positiva, y mujeres en período de lactancia.
14. Mujeres en edad fértil que no se comprometan a realizarse el test de embarazo y a utilizar métodos anticonceptivos válidos durante el estudio y hasta una semana después de la finalización del mismo. Se consideran métodos anticonceptivos válidos los siguientes: método barrera (diafragma, preservativo), dispositivo intrauterino (DIU), pareja vasectomizada, abstinencia sexual, anticonceptivos hormonales, sistema intrauterino (SIU), oclusión tubaria bilateral.
15. Pacientes VIH positivos conocido en los últimos cinco años.
16. Pacientes con proceso oncológico activo en los últimos cinco años.
17. Pacientes que hayan recibido un fármaco en investigación (incluyendo vacunas) o hayan usado un dispositivo médico invasivo en investigación en los últimos 30 días previos al inicio de la fase de selección o estén actualmente participando en otro ensayo clínico.

E.5 End points

E.5.1

Primary end point(s)

The main variable of the study is the percentage of patients with a decrease of two points or more on the scale - VAS * (0-10 points) of pain at T156h +30 min (day 7 hours 12 + 30min) with respect to T (0) ( day 1 hour 0).

La variable principal del estudio es el porcentaje de pacientes con disminución de dos puntos o más en la escala – EVA* (0-10 puntos) del dolor a T156h +30 min (día 7 hora 12 + 30min) respecto T(0) (día 1 hora 0).

E.5.1.1

Timepoint(s) of evaluation of this end point

T(0), T15min, T30min, T1h, T4h, T8h, T12h, T12h-15min, T12h-30min, T36h, T36h-15min, T36h-30min, T60h, T60h-15min, T60h-30min, T84h, T84h-15min, T84-30min, T108h, T108h-15min, T108h-30min, T132h, T132h-15min, T132-30min, T156h, T156h-15min, T156h-30min

E.5.2

Secondary end point(s)

1. Evaluation of the speed of action on local pain relief, being considered as the time needed to achieve a variation of the Visual Analog Scale - VAS (0-10 points), with respect to the baseline value (T (0)), for each established time.
2. The evaluation of the variation of pruritus (itching that causes the need or desire to scratch) will be carried out using the Visual Analog Scale - VAS (0-10 points), assessed by the patient at the established times, with respect to the value baseline (T (0)).
3. The evaluation of the stinging-burning variation will be carried out using the Visual Analog Scale - VAS (0-10 points), assessed by the patient at the established times, with respect to the baseline value (T (0)). The evaluation of the variation of the inflammation (increase in volume, redness, local heat and pain) will be carried out by the researcher during the physical examination, using Visual Visual Scale - VAS (0-10 points) in Visit 1 (day 1) and Visit 2 (day 8), or the “Unscheduled” (unscheduled) Visit, (if any), and will be assessed with respect to the baseline value (T (0)).
5. The evaluation of bleeding (presence of red blood gleaming, in the stool, in the wash water and / or in the toilet paper after cleaning the anal area) will be performed by the patient. The investigator will ask the patient whether or not he has experienced any bleeding episode in the last week on Visit 1 (day 1) and Visit 2 (day 8), or on the “Unscheduled” (unscheduled) Visit (if any), and will be valued with respect to the baseline value (T (0)).
6. Evaluation of the patient's quality of life related to the pathology by completing the SF-36 questionnaire, evaluated by the patient on Visit 1 (day 1) and Visit 2 (day 8), or on the “Unscheduled” Visit (not programmed), (if any), and will be valued with respect to the baseline value (T (0)). The quality of life is defined as the subjective degree of well-being attributed or associated with the lack of symptoms, the psychological state and the activities that are desired to be carried out. The SF-36 questionnaire is a validated tool with reference values that evaluates the health and well-being of the patient. This questionnaire includes 36 items distributed in 8 dimensions or scales of perceived health.

1. Evaluación de la rapidez de acción sobre el alivio local del dolor, considerándose como el tiempo necesario hasta conseguir una variación de la Escala Visual Analógica – EVA (0-10 puntos), con respecto al valor basal (T(0)), para cada tiempo establecido.
2. La evaluación de la variación del prurito (picor que provoca la necesidad o el deseo de rascarse) se realizará mediante la Escala Visual Analógica – EVA (0-10 puntos), valorado por el paciente a los tiempos establecidos, con respecto al valor basal (T(0)).
3. La evaluación de la variación del escozor – ardor se realizará mediante la Escala Visual Analógica – EVA (0-10 puntos), valorado por el paciente a los tiempos establecidos, con respecto al valor basal (T(0)).4. La evaluación de la variación de la inflamación (aumento de volumen, enrojecimiento, calor local y dolor) será realizada por el investigador durante el examen físico, mediante Escala Visual Analógica – EVA (0-10 puntos) en la Visita 1 (día 1) y Visita 2 (día 8), o en la Visita “Unscheduled” (no programada), (si hubiera), y se valorará con respecto al valor basal (T(0)).
5. La evaluación del sangrado (presencia de sangre rojo rutilante, en las heces, en el agua del lavado y/o en el papel higiénico posterior a limpiar la zona anal) será realizada por el paciente. El investigador preguntará al paciente si ha experimentado o no algún episodio de sangrado enla última semana en la Visita 1 (día 1) y Visita 2 (día 8), o en la Visita “Unscheduled” (no programada), (si hubiera), y se valorará con respecto al valor basal (T(0)).
6. Evaluación de la calidad de vida del paciente relacionada con la patología mediante la realización del cuestionario SF-36, evaluada por el paciente en la Visita 1 (día 1) y Visita 2 (día 8), o en la Visita “Unscheduled” (no programada), (si hubiera), y se valorará con respecto al valor basal (T(0)). La calidad de vida se define como el grado subjetivo de bienestar atribuido o asociado a la carencia de síntomas, el estado psicológico y las actividades que se desean realizar. El cuestionario SF-36 es una herramienta validada con valores de referencia que evalúa la salud y bienestar del paciente. Este cuestionario incluye 36 ítems distribuídos en 8 dimesiones o escalas de salud percibida.

E.5.2.1

Timepoint(s) of evaluation of this end point

Endpoint 1, 2 and 3:T(0), T15min, T30min, T1h, T4h, T8h, T12h, T12h-15min, T12h-30min, T36h, T36h-15min, T36h-30min, T60h, T60h-15min, T60h-30min, T84h, T84h-15min, T84-30min, T108h, T108h-15min, T108h-30min, T132h, T132h-15min, T132-30min, T156h, T156h-15min, T156h-30min
Endpoint 4, 5, 6:Visit 1 (day 1) y Visit 2 (day 8)

Variables 1, 2 and 3:T(0), T15min, T30min, T1h, T4h, T8h, T12h, T12h-15min, T12h-30min, T36h, T36h-15min, T36h-30min, T60h, T60h-15min, T60h-30min, T84h, T84h-15min, T84-30min, T108h, T108h-15min, T108h-30min, T132h, T132h-15min, T132-30min, T156h, T156h-15min, T156h-30min
Variables 4, 5, 6:Visita 1 (día 1) y Visita 2 (día 8)

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)

Yes

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

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

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

UVUS

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:

185

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

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

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

185

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

2019-10-15

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-10-09

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

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