Clinical Trials Register

Summary
EudraCT Number:	2018-001412-30
Sponsor's Protocol Code Number:	FMLD-FEBETRADI-PILOT-43_FIII
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:	2018-05-21
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

2018-001412-30

A.3

Full title of the trial

Double blind, randomized, pilot clinical trial controlled with placebo to evaluate the comparative efficacy of ibuprofen combined with different doses of tramadol and tramadol 100 mg by intravenous route in patients with moderate-intense pain after dental surgery.

ENSAYO CLÍNICO, PILOTO, DOBLE CIEGO, ALEATORIZADO, CONTROLADO CON PLACEBO PARA EVALUAR LA EFICACIA COMPARADA DE IBUPROFENO COMBINADO CON DIFERENTES DOSIS DE TRAMADOL Y TRAMADOL 100 MG POR
VÍA INTRAVENOSA EN PACIENTES CON DOLOR MODERADO A INTENSO TRAS CIRUGÍA DENTAL.

A.3.1

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

CLINICAL TRIAL TO EVALUATE THE EFFICACY OF IBUPROFEN COMBINED WITH DIFFERENT DOSES OF TRAMADOL AND TRAMADOL INTRAVENOUS AFTER DENTAL SURGERY

ENSAYO CLÍNICO PARA EVALUAR LA EFICACIA IBUPROFENO COMBINADO CON DIFERENTES DOSIS DE TRAMADOL Y TRAMADOL POR VÍA INTRAVENOSA PARA EL DOLOR TRAS CIRUGÍA DENTAL.

A.3.2

Name or abbreviated title of the trial where available

FMLD-FEBETRADI-PILOT-43_FIII

A.4.1

Sponsor's protocol code number

FMLD-FEBETRADI-PILOT-43_FIII

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	Laboratorios Farmalíder 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	Laboratorios Farmalíder 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	Laboratorios Farmalíder S.A.
B.5.2	Functional name of contact point	Develop and technical support
B.5.3	Address:
B.5.3.1	Street Address	Calle La granja 1-3º
B.5.3.2	Town/ city	Alcobendas (Madrid)
B.5.3.3	Post code	28108
B.5.3.4	Country	Spain
B.5.4	Telephone number	+34916612335
B.5.5	Fax number	+34916610442
B.5.6	E-mail	carloscalandria@farmalider.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Ibuprofen/tramadol
D.3.4	Pharmaceutical form	Solution for 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.3.8	INN - Proposed INN	INN
D.3.9.1	CAS number	27203-92-5
D.3.9.2	Current sponsor code	Tramadol
D.3.9.3	Other descriptive name	TRAMADOL HYDROCHLORIDE
D.3.9.4	EV Substance Code	SUB04927MIG
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	37.5
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	IBUPROFEN
D.3.9.1	CAS number	15687-27-1
D.3.9.2	Current sponsor code	IBUPROFEN
D.3.9.3	Other descriptive name	IBUPROFEN
D.3.9.4	EV Substance Code	SUB08098MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	400
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.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	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	Ibuprofen/tramadol
D.3.4	Pharmaceutical form	Solution for 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.3.8	INN - Proposed INN	INN
D.3.9.1	CAS number	27203-92-5
D.3.9.2	Current sponsor code	Tramadol
D.3.9.3	Other descriptive name	TRAMADOL HYDROCHLORIDE
D.3.9.4	EV Substance Code	SUB04927MIG
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	75
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	IBUPROFEN
D.3.9.1	CAS number	15687-27-1
D.3.9.2	Current sponsor code	IBUPROFEN
D.3.9.3	Other descriptive name	IBUPROFEN
D.3.9.4	EV Substance Code	SUB08098MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	400
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.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	Adolonta
D.2.1.1.2	Name of the Marketing Authorisation holder	Grünenthal Pharma, 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	Solution for injection
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.3.8	INN - Proposed INN	INN
D.3.9.1	CAS number	27203-92-5
D.3.9.2	Current sponsor code	adolonta
D.3.9.3	Other descriptive name	TRAMADOL HYDROCHLORIDE
D.3.9.4	EV Substance Code	SUB04927MIG
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	100
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 infusion
D.8.4	Route of administration of the placebo	Intravenous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Moderate-Intense pain in Dental Surgery

Dolor moderado-intenso en cirugía dental

E.1.1.1

Medical condition in easily understood language

Moderate-Intense pain in Dental Surgery

Dolor moderado-intenso en cirugía dental

E.1.1.2

Therapeutic area

Diseases [C] - Mouth and tooth diseases [C07]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	HLT
E.1.2	Classification code	10044049
E.1.2	Term	Dental pain and sensation disorders
E.1.2	System Organ Class	100000004856

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 in a preliminary way the analgesic efficacy measured by the Visual Analog Scale (VAS) 6 hour before administration of a single dose of the fixed-dose combination of ibuprofen (arginate) 400 mg with two dose of intravenous medication versus tramadol 100 mg IV, controlled with placebo.

Evaluar de modo preliminar la eficacia analgésica medida por la Escala Visual Analógica (EVA) a las 6 horas de administrada una dosis única de la combinación a dosis fija de ibuprofeno (arginato) 400 mg con dos niveles de dosis de tramadol por vía intravenosa frente a tramadol 100 mg IV, controlado con placebo.

E.2.2

Secondary objectives of the trial

To estimate the measure and variability of the analgesic effect of each of the ibuprofen combinations (arginate) and tramadol IV vs placebo.
To estimate the measure and variability of the analgesic effect of tramadol 100 mg IV vs placebo.
To evaluate the safety and tolerability of each medication or combination used in order to improve the patients safety.

Estimar medida y variabilidad del efecto analgésico de cada una de las combinaciones de ibuprofeno (arginato) y tramadol IV vs placebo.
Estimar medida y variabilidad del efecto analgésico de tramadol 100 mg IV vs placebo.
Evaluar la seguridad y la tolerabilidad de cada una de las medicaciones o combinaciones empleadas, con el fin de mejorar el perfil de seguridad de los pacientes.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Patients who give their informed consent in writing and are willing to comply with all the visits and scheduled procedures required by the protocol.
2. Patients ≥ 18 years.
3. Moderate-intense pain (SAV 0-100 ≥55 mm) during the first 4 hours after completing the surgery.
4. With body weight> 50 and <110 kg.
5. Scheduled for ambulatory surgical removal, under local anesthesia, of at least two third parties molars, at least one of them lower, and at least one of them impacted that requires elimination of bone.
6. That they agree not to take analgesics except for those that the protocol defines as medication of rescue during the treatment period, until after 7 hours after the administration of the study medication.
7. Have a medical history and physical examination without clinically relevant abnormalities in function of the study and at the discretion of the researcher

1. Pacientes que otorguen su consentimiento informado por escrito y dispuestos a cumplir con todas las visitas y los procedimientos programados que requiere el protocolo.
2. Pacientes ≥ 18 años.
3. Con dolor moderado-intenso (EVA0-100 ≥55 mm) durante las primeras 4 horas tras finalizar la cirugía.
4. Con peso corporal >50 y < 110 kg.
5. Programados para la extracción quirúrgica ambulatoria, bajo anestesia local, de al menos dos terceros molares, al menos uno de ellos inferior, y al menos uno de ellos impactado que requiera eliminación de hueso.
6. Que acepten no tomar analgésicos a excepción de los que el protocolo define como medicación de rescate durante el período de tratamiento, hasta pasadas 7 horas tras la administración de la medicación del estudio.
7. Que tengan un historial médico y exploración física sin anomalías clínicamente relevantes en función del estudio y a criterio del investigador.

E.4

Principal exclusion criteria

1. Patients with a history of allergy or hypersensitivity to the study medication, medication of rescue or any other non-steroidal anti-inflammatory drug (NSAID), opioids or acid acetylsalicylic, or any of its excipients.
2. History of asthma, bronchospasm, acute rhinitis, nasal polyps, urticaria or edema
angioneurotic.
3. History of peptic ulcer, gastrointestinal disorders due to NSAID, gastrointestinal hemorrhage or other active hemorrhages.
4. History of moderate to severe renal, hepatic or cardiac insufficiency.
5. Hemorrhagic diathesis or other coagulation disorders.
6. Epilepsy.
7. Crohn's disease or ulcerative colitis.
8. History of dependence on drugs of abuse or alcohol.
9. History of any disease or disorder that, in the opinion of the investigator, could constitute a risk to the patient or modify the results of the study (eg patients with acute pain of any other origin or location at the time of surgery).
10. Have had complications during the surgery, with duration greater than 1 hour and
that required re-anesthesia (after the appropriate level of anesthesia has been reached).
11. That they have consumed analgesics (including prescription and over-the-counter pain medications) during 48 hours prior to surgery, or in the previous 5 days in the case of consumption of inhibitors of the COX-2.
12. Patients unable to abstain from alcohol, psychotropic drugs or sedatives (eg.
benzodiazepines) or other medications that should not be administered due to the risk of interactions for 48 hours before the start of surgery and during the 12 hours following the administration of the study medication.
13. That they have received an experimental drug or used an experimental medical device within the term of the 30 days prior to the selection.
14. Pregnant or lactating women.
15. That they can not comply with the requirements of the study or that in the opinion of the investigator should not take part.

1. Pacientes con antecedentes de alergia o hipersensibilidad a la medicación del estudio, la medicación de rescate o a cualquier otro antiinflamatorio no esteroideo (AINE), a los opiáceos o al ácido acetilsalicílico, o a alguno de sus excipientes.
2. Antecedentes de asma, broncoespasmo, rinitis aguda, pólipos nasales, urticaria o edema
angioneurótico.
3. Antecedentes de úlcera péptica, trastornos gastrointestinales por AINE, hemorragia gastrointestinal u
otras hemorragias activas.
4. Antecedentes de insuficiencia renal, hepática o cardiaca de moderada a grave.
5. Diátesis hemorrágica u otros trastornos de la coagulación.
6. Epilepsia.
7. Enfermedad de Crohn o colitis ulcerosa.
8. Antecedentes de dependencia de drogas de abuso o alcohol.
9. Antecedentes de cualquier enfermedad o trastorno que, a criterio del investigador, pudiera constituir
un riesgo para el paciente o alterar los resultados del estudio (p.ej. pacientes con dolor agudo de
cualquier otro origen o localización en el momento de la cirugía).
10. Que hayan tenido complicaciones durante la cirugía, con duración de la misma superior a 1 hora y
que hayan requerido reanestesia (después de alcanzado el nivel de anestesia adecuado).
11. Que hayan consumido analgésicos (incluyendo los de prescripción y los de venta sin receta) durante
las 48 horas previas a la cirugía, o en los 5 días previos en el caso de consumo de inhibidores de la
COX-2.
12. Pacientes incapaces de abstenerse de consumir alcohol, psicofármacos o sedantes (p.ej.
benzodiacepinas) u otros medicamentos que no deben administrarse debido al riesgo de interacciones
durante 48 horas antes del inicio de la cirugía y durante las 12 horas siguientes a la administración de
la medicación del estudio.
13. Que hayan recibido un fármaco experimental o usado un dispositivo médico experimental en el plazo
de los 30 días previos a la selección.
14. Mujeres embarazadas o en período de lactancia.
15. Que no puedan cumplir con los requisitos del estudio o que en opinión del investigador no deben
participar.

E.5 End points

E.5.1

Primary end point(s)

intensity of pain, measured through a Scale Visual Analogic (VAS)

intensidad del dolor, medida a través de una Escala Visual Analógica (EVA)

E.5.1.1

Timepoint(s) of evaluation of this end point

6 hours after the administration of the investigational medication

6 horas tras administración del fármaco

E.5.2

Secondary end point(s)

Difference in pain intensity (PIDt).
Sum of the pain intensity differences (SPID).
Pain relief (PRt) by the EVA scale score
Relief of total pain (TOTPAR).
Rate of responding patients.
Rate of use of rescue medication.
Time until the administration of rescue medication.

Diferencia en intensidad de dolor (PIDt)
Suma de las diferencias de intensidad de dolor (SPID)
Alivio del dolor (PRt)
Alivio del dolor total (TOTPAR).
Tasa de pacientes respondedores.
Tasa de uso de medicación de rescate.
Tiempo hasta la administración de la medicación de rescate.

E.5.2.1

Timepoint(s) of evaluation of this end point

Difference in pain intensity (PIDt) for each observation point established up to 7 hours (PIDt = PI0-PIt, where PI0 = intensity of pain in time t = 0 h according to the EVA and PIt = intensity of pain at each time point according to the EVA).
Sum of the pain intensity differences (SPID). Up to 7 hours.
Pain relief (PRt) from the start of the medication until 7 hours after the administration of the medication [by the EVA scale score (0: none of relief, 100: total relief)].
Relief of total pain (TOTPAR) until 7 hour.
Rate of responding patients: end of the study.
Rate of use of rescue medication: end of the study.
Time until the administration of rescue medication: end of the study.

Diferencia en intensidad de dolor (PIDt) para cada punto de observación establecido hasta las 7 horas (PIDt= PI0-PIt, siendo PI0=intensidad de dolor en el tiempo t=0 h según la EVA y PIt= intensidad de dolor en cada punto de tiempo según la EVA).
Suma de las diferencias de intensidad de dolor (SPID).hasta las 7 horas.
Alivio del dolor (PRt) desde el inicio de la medicación hasta 7 horas después de la
administración del medicamento [mediante la puntuación de la escala EVA (0: nada de
alivio, 100:alivio total)].
Alivio del dolor total (TOTPAR) hasta las 7 horas.
Tasa de pacientes respondedores: al final del estudio.
Tasa de uso de medicación de rescate: al final del estudio.
Tiempo hasta la administración de la medicación de rescate: al final del estudio.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

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

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

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

Ultimo paciente, ultima visita

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:

112

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

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

112

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

2018-07-13

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-07-04

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

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