Clinical Trials Register

Summary
EudraCT Number:	2014-004081-21
Sponsor's Protocol Code Number:	FMLD-IOTRA-20_FIIIB
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:	2014-11-04
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

2014-004081-21

A.3

Full title of the trial

A PHASE III, MULTICENTRE, INTERNATIONAL, RANDOMISED, DOUBLE-BLIND, DOUBLE-DUMMY,
PARALLEL-GROUP, PLACEBO AND ACTIVE COMPARATORCONTROLLED CLINICAL TRIAL TO EVALUATE THE ANALGESIC EFFICACY AND SAFETY OF IBUPROFEN ARGININE/TRAMADOL 400/37.5 MG COMPARED WITH IBUPROFEN ARGININE 400 MG ALONE, TRAMADOL 50 MG ALONE AND PLACEBO IN PATIENTS WITH MODERATE TO SEVERE PAIN AFTER NON-ONCOLOGICAL ABDOMINAL
HYSTERECTOMY

ENSAYO CLÍNICO EN FASE III, MULTICÉNTRICO, INTERNACIONAL, ALEATORIZADO, DOBLE CIEGO, CON DOBLE SIMULACIÓN, DE GRUPOS PARALELOS, CONTROLADO CON COMPARADOR ACTIVO Y PLACEBO, PARA EVALUAR LA EFICACIA ANALGÉSICA Y SEGURIDAD DE IBUPROFENO ARGININA/TRAMADOL 400/37,5 MG COMPARADO CON IBUPROFENO ARGININA 400 MG SOLO, TRAMADOL 50 MG SOLO Y PLACEBO EN PACIENTES CON DOLOR DE MODERADO A SEVERO TRAS HISTERECTOMÍA ABDOMINAL NO ONCOLÓGICA

A.3.1

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

Trial to evaluate the analgesic efficacy and safety of ibuprofen arginine/tramadol compared with ibuprofen alone and placebo, in patients with moderate to severe pain after non-oncological abdominal hysterectomy.

Ensayo Clínico para evaluar la eficacia analgésica y seguridad de ibuprofeno arginina junto a tramadol, comparado con ibuprofeno arginina solo, tramadol solo y placebo en pacientes con dolor de moderado a severo tras histerectomía abdominal no oncológica

A.3.2

Name or abbreviated title of the trial where available

IOTRA

A.4.1

Sponsor's protocol code number

FMLD-IOTRA-20_FIIIB

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	ALPHA BIORESEARCH, S.L.
B.5.2	Functional name of contact point	Natividad Gonzalez
B.5.3	Address:
B.5.3.1	Street Address	Paseo de la Castellana, 163
B.5.3.2	Town/ city	Madrid
B.5.3.3	Post code	28046
B.5.3.4	Country	Spain
B.5.4	Telephone number	34917452520
B.5.5	Fax number	34917450653
B.5.6	E-mail	natividad.gonzalez@alphabioresearch.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	Ibuprofeno (arginina) / Tramadol HCI
D.3.4	Pharmaceutical form	Granules for oral solution
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	IBUPROFENO ARGINATO
D.3.9.1	CAS number	15687-27-1
D.3.9.2	Current sponsor code	no aplica
D.3.9.3	Other descriptive name	no aplica
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.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	TRAMADOL HIDROCLORURO
D.3.9.1	CAS number	36282-47-0
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.3.11 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	IBUPROFENO (ARGININA) 400 MG GRANULADO PARA SOLUCIÓN ORAL
D.2.1.1.2	Name of the Marketing Authorisation holder	ESPIDIFEN
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	IBUPROFENO (Arginina)
D.3.4	Pharmaceutical form	Granules for oral suspension
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	IBUPROFENO ARGINATE
D.3.9.1	CAS number	15687-27-1
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	TRAMADOL HIDROCLORURO 100 mg/ml.
D.2.1.1.2	Name of the Marketing Authorisation holder	ADOLONTA
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	TRAMADOL HCI
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	TRAMADOL HIDROCLORURO
D.3.9.1	CAS number	36282-47-0
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/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	50
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	Granules for oral solution
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Granules for oral solution
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 3
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

Evaluation of the analgesic efficacy in patients with moderate to severe pain after non-oncological abdominal surgery.

Evaluación de la eficacia de la analgesia en pacientes con dolor de moderado a severo tras histerectomía abdominal no oncológica

E.1.1.1

Medical condition in easily understood language

Evaluation of the analgesic efficacy in patients with moderate to severe pain after non-oncological abdominal surgery.

Evaluación de la eficacia de la analgesia en pacientes con dolor moderado a severo tras haberles realizado una histerectomía abdominal no oncológica

E.1.1.2

Therapeutic area

Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	17.1
E.1.2	Level	PT
E.1.2	Classification code	10021151
E.1.2	Term	Hysterectomy
E.1.2	System Organ Class	10042613 - Surgical and medical procedures

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The primary objective is to evaluate the analgesic efficacy of the combination at fixed doses of ibuprofen arginine and tramadol hydrochloride, in oral administration, versus the components separately and placebo, in patients with moderate to severe pain after abdominal surgery.

El objetivo principal es evaluar la eficacia analgésica de la combinación a dosis fijas de ibuprofeno arginina y tramadol hidrocloruro, en administración oral, frente a los componentes por separado y placebo, en pacientes con dolor de moderado a severo tras cirugía abdominal.

E.2.2

Secondary objectives of the trial

The secondary objective is to evaluate single-dose efficacy and the safety and tolerability of all the products.

Como objetivo secundario se evaluará la eficacia a dosis única así como la seguridad y la tolerabilidad de todos los preparados.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Main inclusion criteria:
1. Female, from 18 to 75 years of age.
2. Scheduled for total or partial abdominal hysterectomy due to a benign process, requiring hospitalisation for at least 48 hours after the surgery.
3. Mentally competent, able to understand and grant their written informed consent before entering the study. Willing to undergo the scheduled study procedures, including entering their pain assessment value in the patient diary as established in the protocol.
4. Class I, II or III of the ASA (American Society of Anesthesiologists) patient classification system.
5. Patient with at least moderate (VAS ≥ 4 cm) pain at rest the day after surgery, able to swallow oral medication, for whom randomisation and dose allocation is possible within 4 hours of withdrawing intravenous analgesia.

1. Sexo femenino, de 18 a 75 años.
2. Programada para someterse a histerectomía abdominal total o parcial por un proceso benigno, que precisa hospitalización durante al menos 48 después de la intervención.
3. Mentalmente competente, capaz de comprender y de otorgar su consentimiento informado por escrito antes de la entrada en el estudio. Conforme en someterse a los procedimientos programados del estudio, incluido el registro de su valoración del dolor en el diario de paciente en la forma exigida por el protocolo.
4. Clase I, II o III del Sistema de Clasificación del Paciente ASA (American Society of Anaesthesiologists).
5. Paciente con dolor en reposo de intensidad como mínimo moderada (EVA ? 4 cm) el día después de la cirugía, capaz de tragar medicación oral y siendo posible la aleatorización y asignación de dosis en las 4 horas posteriores a la retirada de la analgesia intravenosa.

E.4

Principal exclusion criteria

1. Patient considered by the investigator to be unsuitable for the study treatment and/or rescue medication (RM) based on her medical history, physical examination, concomitant medication (CM) and concomitant systemic diseases.
2. Complications during the surgery or the period prior to randomisation, in the investigator's opinion.
3. Local or systemic acute infection at the time of surgery that could confuse the post-surgical assessment.
4. Patients with clinical signs of gastritis, history of peptic ulcer, GI haemorrhage or diseases that, in the investigator's opinion, could be negatively affected by the administration of an NSAID.
5. Clinical signs or history of clotting disorders that could be negatively affected by the administration of an NSAID.
6. Severe liver, kidney or heart failure.
7. History of seizures or drug or alcohol abuse in the six months before the study.
8. Patients in chronic treatment with NSAIDs and/or opioids (major and tramadol).
9. Patients who use and cannot suspend topical or systemic analgesics other than those specified in the protocol, from before the start of the surgery (5 days before in the case of COX-2 inhibitors) until the end of the last pain assessment.
10. Patients on treatment with drugs that reduce the seizure threshold (MAO inhibitors, SSRIs, methylphenidate, etc.).
11. Hypersensitivity or allergy to the study drugs or RM.
12. Patients taking any concomitant medication, the use of which could be susceptible to interacting with ibuprofen and/or tramadol, or could affect safety.
13. Breastfeeding women.

1. Paciente considerada por el investigador como no adecuada para el tratamiento del estudio y/o la medicación de rescate (MR) en función de su historia médica, exploración física, medicación concomitante (MC) y enfermedades sistémicas concomitantes.
2. Complicaciones durante la cirugía o en el período previo a la asignación aleatoria, a criterio del investigador.
3. Infección aguda local o sistémica en el momento de la cirugía que pudiera confundir la evaluación post?quirúrgica.
4. Pacientes con signos clínicos de gastritis, antecedentes de úlcera péptica, hemorragia GI o enfermedades que, a juicio del investigador, podrían verse afectadas negativamente por la administración de un AINE.
5. Signos clínicos o antecedentes de trastornos de la coagulación que podrían verse afectados negativamente por la administración de un AINE.
6. Insuficiencia hepática, renal o cardíaca severa.
7. Historia de convulsiones o abuso de drogas o alcohol en los seis meses previos al estudio.
8. Pacientes en tratamiento crónico con AINES y/o opioides (mayores y tramadol).
9. Pacientes que usen y no puedan suspender analgésicos tópicos o sistémicos distintos de los especificados en el protocolo, desde antes del comienzo de la cirugía (5 días antes en el caso de inhibidores de la COX-2) hasta la finalización de la última evaluación del dolor.
10. Pacientes en tratamiento con fármacos que reducen el umbral convulsivo (IMAOs, ISRSs, metilfenidato, etc.).
11. Hipersensibilidad o alergia a los fármacos del estudio o MR.
12. Pacientes bajo tratamiento con cualquier medicación concomitante cuyo uso pueda ser susceptible de interaccionar con ibuprofeno y/o tramadol o pueda afectar a la seguridad.
13. Mujeres en período de lactancia.

E.5 End points

E.5.1

Primary end point(s)

Efficacy: The primary efficacy endpoint will be pain intensity as measured by VAS. The main criterion of the analysis will be pain intensity 24 hours after the start of the treatment.

Safety: The safety evaluations will include a general physical examination, vital signs and rate of adverse events.

Eficacia: la variable principal de eficacia será la intensidad del dolor medida a través de la EVA. El criterio principal del análisis será la intensidad de dolor a las 24 horas del inicio del tratamiento.

Seguridad: las evaluaciones de seguridad incluirán una exploración física general, constantes vitales y tasa de acontecimientos adversos.

E.5.1.1

Timepoint(s) of evaluation of this end point

24 h.

E.5.2

Secondary end point(s)

Secondary: The secondary endpoints will be:
• Pain intensity differences (PID) and reduction of pain (SPID - Score Pain Intensity Differences) at 6 (SPID 0-6h), 24 (SPID 0-24h) and 48 (SPID 0-48h) hours.
• Rescue medication: rate of use of rescue medication, time to use of rescue medication.
• Pain relief at each time point. Total pain relief at 6, 24 and 48 hours (TOTPAR 0-6h, 0-24h and 0-48h) and time to significant relief.
• Rate of patients who respond to the treatment.

Secundarias: como variables secundarias se analizarán:
• Diferencias en la intensidad de dolor (PID) y diminución del dolor (SPID - Score Pain Intensity Differences) a las 6 (SPID 0-6h), 24 (SPID 0-24h) y 48 (SPID 0-48h) horas.
• Medicación de rescate: tasa de uso de medicación de rescate, tiempo hasta el uso de medicación de rescate.
• Alivio del dolor en cada punto de tiempo. Alivio del dolor total a las 6, 24 y 48 horas (TOTPAR 0-6h, 0-24h y 0-48h) y tiempo hasta alivio significativo,
• Tasa de pacientes que responden al tratamiento.

E.5.2.1

Timepoint(s) of evaluation of this end point

6, 24, 48 h.

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

Yes

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

Doble simulación

Double dummy

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

Yes

E.8.5.1

Number of sites anticipated in the EEA

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

Última visita del último paciente.

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

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:

200

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

244

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

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

375

F.4.2

For a multinational trial

F.4.2.1

In the EEA

444

F.4.2.2

In the whole clinical trial

444

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

2015-01-02

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2014-12-12

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2016-04-21

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Clinical trials