Clinical Trials Register

Summary
EudraCT Number:	2013-004637-33
Sponsor's Protocol Code Number:	FMLD-IOTRA-20_FIIIA
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:	2014-04-25
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2013-004637-33

A.3

Full title of the trial

Clinical trial phase III, multicenter, randomised, double-blind, double-dummy, parallel treatment design, active-controlled and placebo, to evaluate the analgesic efficacy and safety of ibuprofen arginine/tramadol 400/37,5 mg compared to ibuprofen arginine 400 mg single, tramadol 50 mg single and placebo in patients with moderate to severe pain after dental surgery.

Ensayo clínico en fase III, multicéntrico, 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 sólo, tramadol 50 mg sólo y placebo 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

Oral treatment for evaluate postoperative pain in dental surgery with ibuprofen arginine/tramadol, ibuprofen arginine single, tramadol single or placebo.

Tratamiento oral para evaluar el dolor postoperatorio en cirugía dental con ibuprofeno arginina /tramadol, arginina ibuprofeno solo, tramadol solo o placebo.

A.4.1

Sponsor's protocol code number

FMLD-IOTRA-20_FIIIA

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 Farmalider 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	Fundación Teófilo Hernando
B.5.2	Functional name of contact point	Antonio Bazán Carbonell
B.5.3	Address:
B.5.3.1	Street Address	Avda. Arzobispo Morcillo 4
B.5.3.2	Town/ city	Madrid
B.5.3.3	Post code	28029
B.5.3.4	Country	Spain
B.5.4	Telephone number	34914973120
B.5.5	Fax number	34914973120
B.5.6	E-mail	javier.soriano@uam.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	Ibuprofen (arginine)/Tramadol HCl 400/37,5 mg
D.3.2	Product code	test
D.3.4	Pharmaceutical form	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
D.3.9.2	Current sponsor code	test
D.3.9.3	Other descriptive name	IBUPROFEN ARGININE
D.3.9.4	EV Substance Code	SUB22225
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 HCl
D.3.9.2	Current sponsor code	test
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	Espidifen 400 mg
D.2.1.1.2	Name of the Marketing Authorisation holder	Laboratorios ZAMBON
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	Espidifen 400 mg granulated
D.3.2	Product code	Reference
D.3.4	Pharmaceutical form	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	Ibuprofen
D.3.9.2	Current sponsor code	comparator
D.3.9.3	Other descriptive name	IBUPROFEN ARGININE
D.3.9.4	EV Substance Code	SUB22225
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 100 mg/ml
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.3.1	Product name	Adolonta
D.3.2	Product code	reference
D.3.4	Pharmaceutical form	Oral drops, 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	Tramadol HCl
D.3.9.2	Current sponsor code	Comparator
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	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	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, solution
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

Moderate to severe pain following dental surgery.

Dolor moderado a severo tras cirugía dental

E.1.1.1

Medical condition in easily understood language

Moderate to severe pain

Dolor moderado a severo

E.1.1.2

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

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

The main objective consists on evaluating the analgesic efficacy of oral ibuprofen arginine and tramadol hydrochloride fixed combination versus each component single and placebo, in patients with moderate to severe pain after dental surgery.

El objetivo principal consiste en evaluar la eficacia analgésica de la combinación a dosis fijas de ibuprofeno arginina y tramadol hidrocloruro frente a cada componente por separado y placebo, en administración oral, en pacientes con dolor moderado a intenso tras cirugía dental.

E.2.2

Secondary objectives of the trial

Secondary objectives: To assess the safety and tolerability of ibuprofen arginine and tramadol hydrochloride fixed combination and compared to each components single.

Valorar la seguridad y la tolerabilidad de la combinación a dosis fijas de ibuprofeno arginina y tramadol hidrocloruro y compararlas con la de sus componentes por separado.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Inclusion criteria:
1. Able to understand and sign consent informed before participating in
the study and willing to comply with all visits and procedures
scheduled and collect the information required by the protocol.
2. Men and women of both sexes at least 18 years of age.
3. For women: postmenopausal women or unable by surgery, not pregnant women of child-bearing age who use acceptable methods of birth control and normal menstrual period 3 months before the clinical study.
4. Body weight of more than 50 Kg and less than 110 Kg.
5. Programed people to ambulatory surgical dental removal, under local anesthesia, at least 2 impacted third molars which require bone removal. If only 2 third molars are removed these should be ipsilaterals and at least one of them should require bone removal.
6. People with moderate to severe pain, reaching at least 45 mm in EVA scale for the first 4 hours after surgery.
7. Surgery without complications, surgery time no more than 1 hour and without re-anesthesia.
8. Must accept don´t take analgesics, except rescue medication until treatment described in the Protocol, up to 24 hours after first administration of study medication.
9. With ordinary or without relevant abnormalities medical records and physical exploration, to the discretion of the investigator.
10. People who have not used up analgesics (including those for prescription and non-prescription sale) until 48 hours before the surgery, or 5 days early in the event of consumption of COX-2 inhibitors.
11. For women of childbearing, they should have a negative pregnancy test prior to randomization.

Para participar en el estudio los pacientes han de cumplir todos los siguientes:
1. Capaces de entender y firmar el consentimiento informado antes de participar en el estudio y dispuestos a cumplir con todas las visitas y los procedimientos programados y de recoger la información que requiere el protocolo.
2. Hombres o mujeres de ambos sexos con, al menos, 18 años de edad.
3. En el caso de las mujeres, que estén en etapa posmenopáusica o que no pueden tener hijos por intervención quirúrgica, o mujeres en edad fértil no embarazadas que usen métodos aceptables de control de natalidad y un patrón menstrual normal en los tres meses previos a su entrada en el estudio.
4. Peso corporal superior a 50 kg e inferior a 110 kg.
5. Programados para la extracción quirúrgica ambulatoria, bajo anestesia local, de al menos dos terceros molares impactados que requieran eliminación de hueso. Si sólo se extraen 2 terceros molares, éstos deben ser ipsilaterales y al menos uno requerir eliminación de hueso.
6. Que experimenten un dolor de moderado a intenso, alcanzando una puntuación de al menos 45mm en la EVA durante las primeras 4 horas tras finalizar la cirugía.
7. Sin complicaciones durante la cirugía, con duración de la misma no superior a 1 hora y que no hayan requerido reanestesia.
8. Que acepten no tomar analgésicos a excepción de los que el protocolo define como medicación de rescate durante el período de tratamiento, hasta pasadas 24 horas tras la administración de la primera dosis de la medicación del estudio.
9. Con historial médico y exploración física normales o sin anomalías clínicamente relevantes, a criterio del investigador.
10. Que no hayan consumido analgésicos (incluyendo los de prescripción y los de venta sin receta) durante las 48 horas previas a la cirugía, o 5 días previos en el caso de consumo de inhibidores de la COX-2.
11. En el caso de mujeres con capacidad reproductiva, que tengan una prueba de embarazo negativa antes de la aleatorización.

E.4

Principal exclusion criteria

Exclusion criteria:
1. History of allergy or hypersensitivity to the study medication, to the rescue medication or to the any other NSAID, to the opiates or to the acetylsalicylic acid.
2. History of asthma, bronchospasm, acute rhinitis, nasal polyps, hives or angioneurotic edema.
3. History of peptic ulcers, gastrointestinal disorders caused by NSAID, gastrointestinal bleeding or others active bleedings.
4. Renal, hepatic and cardiac dysfunction moderate to severe.
5. Coagulation disorders.
6. Uncontrolled seizure disorders.
7. Crohn's disease or ulcerative colitis.
8. History of drug addiction and alcohol abuse. According to the study, alcohol abuse is defined in the following manner: average weekly consumption >21 units (men) and >14 units (women), or average daily consumption >3 units (men) and >2 units (women) [1 unit = 125 ml of wine, 200ml of beer, 25ml of liquor]
9. According to the investigator, patients who are not suitable candidates to take the study medication and the rescue medication based on their medical history, concomitant medication systemic concurrent diseases described in the corresponding technical sheets (warnings, precautions, contraindications and adverse events) of ibuprofen, tramadol, paracetamol and metamizole ( paracetamol and metamizole are rescue medication).
10. Inability to abstain from alcohol, psychotropic drugs and sedative medications or others drugs banned (*) until 48 hours or 5 half-lives (the longest possible) before the start of surgery and until 24 hours after of administration of study medication.
(*)different analgesics from study medication, anticoagulants, thrombolytic and antiplatelet agents, corticosteroids, MAO inhibitors, antiepileptic drugs, antipsychotics, SSRIs and tricyclic antidepressants, lithium, methotrexate, sulfonamides.
11. Patients using and don´t be able to interrupt other drugs, prescribed or not, that could interfere with the study medication and study procedures, or could endanger the patient´ safety according to related documentation with the medications included in the study and the rescue medication, until 48 hours or 5 half-lives (the longest possible) before the start of surgery and until 24 hours after of administration of study medication.
12. Patients who have taken an experimental medication or patients who have used an experimental medical device within 30 days before to selection.
13. Pregnant or nursing women.
14. History of any liver disease or disorder which, according to investigator, might constitute a risk to the patient or to alter the results of the study (e.g. patients with severe pain of different origins or location at the surgery moment.)
15. Patients who cannot meet the requirements of the study or must not take part according to the investigator.

Para participar en el estudio, los pacientes no han de cumplir ninguno de los siguientes:
12. 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.
13. Antecedentes de asma, broncoespasmo, rinitis aguda, pólipos nasales, urticaria o edema angioneurótico.
14. Antecedentes de úlcera péptica, trastornos gastrointestinales por AINE, hemorragia gastrointestinal u otras hemorragias activas.
15. Insuficiencia renal, hepática o cardiaca de moderada a grave.
16. Diátesis hemorrágica u otros trastornos de la coagulación.
17. Epilepsia no controlada.
18. Enfermedad de Crohn o colitis ulcerosa.
19. Antecedentes de dependencia de drogas de abuso o alcohol. A efectos del estudio, la dependencia de alcohol se define de la siguiente manera: consumo semanal promedio >21 unidades (hombres) y >14 unidades (mujeres), o consumo diario promedio de >3 unidades (hombres) y >2 unidades (mujeres) (Una unidad corresponde a aprox. 125 ml de vino, 200 ml de cerveza, 25 ml de licores).
20. Pacientes incapaces de abstenerse de consumir alcohol, psicofármacos o sedantes (p.ej. benzodiacepinas) u otros medicamentos prohibidos como los relacionados más abajo durante 48 horas o 5 semividas (lo que sea más prolongado) antes del inicio de la cirugía y durante las 24 horas siguientes a la administración de la medicación del estudio. Los medicamentos prohibidos son los siguientes: analgésicos diferentes de la medicación de estudio, anticoagulantes, trombolíticos y antiagregantes plaquetarios, corticoesteroides, Inhibidores de la MAO, antiepilépticos, antipsicóticos, inhibidores de la recaptación de serotonina y antidepresivos tricíclicos, litio, metotrexato, sulfonamidas.
21. Que hayan recibido un fármaco experimental o usado un dispositivo médico experimental en el plazo de los 30 días previos a la selección.
22. Mujeres embarazadas o en período de lactancia.
23. 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).
24. 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)

? Main parameter for judging the efficacy and main efficacy analysis:
The main variable of the study will be the pain intensity 6 hours after the start of treatment, measured as of EVA points (0-100) at that moment

La variable principal del estudio es la intensidad del dolor, medida a través de una Escala Visual Analógica (EVA) de 100mm y valorada por el paciente. La variable principal de eficacia para el análisis será la Intensidad de dolor a las 6 horas de inicio del tratamiento.

E.5.1.1

Timepoint(s) of evaluation of this end point

9 months

9 meses

E.5.2

Secondary end point(s)

Sum of Pain Intensity Differences (SPID), pain intensity difference (PID), pain relief (PAR), total pain relief (TOTPAR), the percentage of patients that respond to treatment, the percentage of patient that needed rescue medication, time to first intake of rescue medication, time to achieve pain relief and global assessment of study medication.

Suma de las diferencias de intensidad del dolor (SPID), Diferencia de intensidad del dolor (PID), Alivio del dolor (PAR), Alivio del dolor total (TOTPAR), porcentaje de pacientes que necesitaron medicación de rescate, tiempo hasta la primera ingestión de medicación de rescate, tiempo hasta lograr un alivio significativo del dolor, porcentaje de pacientes que responden al tratamiento y evaluación global de la medicación del estudio por el paciente

E.5.2.1

Timepoint(s) of evaluation of this end point

9 months

9 meses

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

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

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

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:

384

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

384

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

2014-06-11

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2014-05-12

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

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials