Clinical Trials Register

Summary
EudraCT Number:	2012-004548-31
Sponsor's Protocol Code Number:	DEX-TRA-05
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:	2013-02-04
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

2012-004548-31

A.3

Full title of the trial

A randomized, double-blind, placebo and active-controlled, parallel-group study to evaluate the analgesic efficacy and safety of dexketoprofen trometamol and tramadol hydrochloride oral fixed combination on moderate to severe acute pain after elective unilateral total hip arthroplasty.

Estudio aleatorizado, doble ciego, controlado con placebo y con comparador activo, de grupos paralelos, para evaluar la eficacia analgésica y la seguridad de una combinación de dosis fijas oral de dexketoprofeno trometamol y tramadol hidrocloruro en el dolor agudo moderado a severo tras una artroplastia total de cadera unilateral programada

A.3.1

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

Oral treatment for post-operative pain with dexketoprofen trometamol and tramadol hydrochloride.

Tratamiento oral para dolor pospoeratorio con dexketoprofeno trometamol y tramadol hidrocloruro

A.4.1

Sponsor's protocol code number

DEX-TRA-05

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	Menarini Ricerche S.p.A.
B.1.3.4	Country	Italy
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	Menarini Ricerche S.p.A.
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Menarini Ricerche S.p.A.
B.5.2	Functional name of contact point	Clinical Research Corporate Directo
B.5.3	Address:
B.5.3.1	Street Address	Via Sette Santi, 1
B.5.3.2	Town/ city	FLORENCE
B.5.3.3	Post code	50131
B.5.3.4	Country	Italy
B.5.4	Telephone number	+3905556809933
B.5.5	Fax number	+390555680597
B.5.6	E-mail	ACapriati@menarini-ricerche.it

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	Dexketoprofen Trometamol + Tramadol Hydrochloride
D.3.2	Product code	DKP.TRIS + TRAM.HCl
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Dexketoprofen
D.3.9.1	CAS number	156604-79-4
D.3.9.2	Current sponsor code	DKP.TRIS
D.3.9.3	Other descriptive name	Dexketoprofen trometamol
D.3.9.4	EV Substance Code	SUB07034MIG
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	25
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Tramadol
D.3.9.1	CAS number	156604-79-4
D.3.9.2	Current sponsor code	TRAM.HCl
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.3.11 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	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	Dexketoprofen Trometamol
D.3.2	Product code	DKP.TRIS
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Dexketoprofen
D.3.9.1	CAS number	156604-79-4
D.3.9.2	Current sponsor code	DKP.TRIS
D.3.9.3	Other descriptive name	Dexketoprofen trometamol
D.3.9.4	EV Substance Code	SUB01630MIG
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	25
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 Hydrochloride Contramal
D.2.1.1.2	Name of the Marketing Authorisation holder	Prodotti FORMENTI SrL
D.2.1.2	Country which granted the Marketing Authorisation	Jersey
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 hydrochloride
D.3.2	Product code	TRAM.HCl
D.3.4	Pharmaceutical form	Capsule
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
D.3.9.1	CAS number	36282-47-0
D.3.9.2	Current sponsor code	TRAM.HCl
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	Film-coated tablet
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	Capsule
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

Treatment of moderate to severe acute pain after elective unilateral total hip arthoplasty

Tratamiento en el dolor agudo moderado a severo tras una artroplastia total de cadera unilateral programada

E.1.1.1

Medical condition in easily understood language

Treatment of acute pain after surgical replacement of hip joint

El tratamiento del dolor agudo después de la cirugía de reemplazo de articulación de la cadera

E.1.1.2

Therapeutic area

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

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	LLT
E.1.2	Classification code	10066714
E.1.2	Term	Acute pain
E.1.2	System Organ Class	100000004867

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 the analgesic efficacy of oral DKP.TRIS and TRAM.HCl fixed combination on moderate to severe pain after elective hip arthroplasty.

Evaluar la eficacia analgésica de la combinación de dosis fijas de DKP.TRIS y TRAM.HCl, de administración oral, sobre el dolor de grado moderado a severo tras artroplastia programada de cadera.

E.2.2

Secondary objectives of the trial

To assess the safety and tolerability of the treatment after single and 5-day repeated doses.

Evaluar la seguridad y la tolerabilidad del tratamiento tras una dosis única y tras dosis repetidas a lo largo de 5 días.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1.Male or female patients aged 18 to 80 years. Females participating in the study must be either: of non-childbearing potential, or willing to use a highly contraceptive method.
2.Scheduled to undergo standard primary (first-time) one-sided total hip replacement surgery due to primary osteoarthritis, requiring hospitalization for at least 5 days after the surgery.
3.ASA (American Society of Anaesthesiologists) Patient Classification Status I, II or III.
4.Patients experiencing pain at rest of at least moderate intensity (PI-VAS ? 40 mm) the day after surgery who are capable of swallowing oral medication and suitable to be randomized and dosed by 10:00 a.m.

1.Hombre o mujer, de 18 a 80 años, las mujeres que participen en el estudio o bien deben ser mujeres no potencialmente fértiles, o mujeres potencialmente fértiles que utilizan habitualmente un método anticonceptivo eficaz
2. Que tengan programada cirugía de artroplastia total de cadera unilateral estándar, primaria (primera vez), por artrosis primaria, que precise hospitalización durante como mínimo 5 días después de la cirugía.
3. Clase I, II o III del Sistema de Clasificación del Paciente ASA (American Society of Anaesthesiologists).
4. Paciente con dolor en reposo de intensidad como mínimo moderada (PI-VAS ? 40 mm) el día después de la cirugía, capaz de tragar medicación oral y siendo posible la aleatorización y asignación de dosis antes de las 10.00 horas de la mañana

E.4

Principal exclusion criteria

1.Patients who are judged by the Investigator not to be suitable candidates for study treatments and RM based on their medical history, physical examination, concomitant medication (CM) and concurrent systemic diseases.
2.Patients with clinically significant abnormalities of vital signs (VS), safety laboratory tests and 12-lead ECG at screening.
3.Patients with history of allergy or hypersensitivity to the study drugs, RM or to any other NSAIDs, opioids, acetyl salicylic acid, pyrazolones or pyrazolidines.
4.Patients with history of peptic ulcer, gastrointestinal disorders by NSAIDs or gastrointestinal bleeding or other active bleedings.
5.Patients with history of severe asthma.
6.Patients with severe renal, hepatic or cardiac dysfunction.
7.Patients with coagulation disorders.
8.Patients with history or current epilepsy.
9.Patients with Crohn?s disease or ulcerative colitis.
10.Patients with acute intermittent hepatic porphyria.
11.Patients with congenital G6PD (glucose-6-phosphate dehydro-genase) deficiency.
12.Patients with impaired bone marrow function (e.g. following treatment with cytostatic drugs) or haematopoiesis disorders.
13.Patients using and not suitable for withdrawing analgesics (NSAIDs, opioids and related drugs), other than those specified in the protocol, prior to the start of surgery (5 days before surgery in case of COX-2 inhibitors) up to completion of last pain assessment (i.e. 8 hours after last intake of study medication).
14.Patients under chronic opioid treatment (major opioids and tramadol).
15.Patients using and not suitable for withdrawing the prohibited medication, within 48 hours or 5 half-lives (whichever is the longer) prior to the start of surgery and up to 24 hours after the last intake of study medication:
16.Patients receiving concomitant treatment with other investigational drugs or who have participated in other clinical trial within 4 weeks before entering the study.
17.Patients with history of drug or alcohol abuse. For the purpose of the study, alcohol abuse is defined as regularly intake of more than 4 units of alcohol per day (1 unit corresponds approximately to 125 ml wine, 200 ml beer, 25 ml spirit).
18.Pregnant and breastfeeding women.
19.Patients experiencing any surgical complication that, in the opinion of the Investigator, advises against their inclusion in the study.

1. Paciente considerado por el Investigador como no adecuado para los tratamientos del estudio o para la MR en función de su historia médica, exploración física, medicación concomitante (MC) y enfermedades sistémicas concomitantes.
2. Paciente con anomalía clínicamente importante de las constantes vitales (CV), determinaciones de laboratorio para estudio de la seguridad y ECG de 12 derivaciones en la selección.
3. Paciente con antecedentes de alergia o hipersensibilidad a los fármacos del estudio, a la MR o a cualquier otro AINE, opioides, ácido acetilsalicílico, pirazolonas o pirazolidinas.
4. Paciente con antecedentes de úlcera péptica, problemas gastrointestinales por AINE o hemorragia gastrointestinal u otro sangrado activo.
5. Paciente con antecedentes de asma severo.
6. Paciente con disfunción renal, hepática o cardiaca severa.
7. Paciente con trastornos de la coagulación.
8. Paciente con antecedentes de epilepsia o epilepsia actual.
9. Paciente con enfermedad de Crohn o colitis ulcerosa.
10. Paciente con porfiria hepática intermitente aguda.
13. Paciente que está utilizando y no puede dejar de emplear analgésicos (AINE, opioides y fármacos relacionados) distintos de los especificados en el protocolo, desde antes del comienzo de la cirugía (5 días antes de la cirugía en el caso de los inhibidores de COX-2) hasta la finalización de la última evaluación del dolor (esto es, 8 horas después de la última toma de la medicación del estudio).
14.Paciente en tratamiento crónico con opioides (opioides mayores y tramadol).
15. Paciente que está utilizando y que no puede suspender la medicación prohibida que se señala a continuación, en el plazo de 48 horas o de 5 semividas de dicha medicación (eligiéndose el mayor de estos plazos) antes del comienzo de la cirugía y hasta 24 horas después de la última toma de la medicación del estudio:
16. Paciente en tratamiento concomitante con otro fármaco en investigación o que haya participado en otro ensayo clínico en el plazo de las 4 semanas previas a entrar en este estudio.
17. Paciente con antecedentes de drogadicción o abuso de alcohol. A los fines de este estudio, el abuso de alcohol se define como la toma habitual de más de 4 unidades de alcohol al día (1 unidad corresponde aproximadamente a 125 ml de vino, 200 ml de cerveza o 25 ml de licor).
18. Mujer embarazada o en lactancia.
19. Paciente que haya experimentado cualquier complicación quirúrgica que, en opinión del Investigador, aconseje no incluirle en el estudio.

E.5 End points

E.5.1

Primary end point(s)

-Mean SPID at rest (Sum of Pain Intensity Differences, calculated as the weighted sum of the PID-VAS values), over 8 hours after the first dose (SPID8).
The primary efficacy variable will be used for the assessment of the co-primary efficacy endpoint to test the superiority of DKP.TRIS + TRAM.HCl versus DKP.TRIS and versus TRAM.HCl administered as single agents in the single-dose phase.

- Valor medio de la SPID (Suma de las Diferencias en la Intensidad del Dolor, en reposo, calculada como la suma ponderada de los valores de PID-VAS), a lo largo de las 8 horas siguientes a la primera dosis (SPID8).
-Se utilizará la variable principal de valoración de la eficacia para las evaluaciones del criterio co-principal de valoración de la eficacia en el examen de la superioridad de DKP.TRIS + TRAM.HCl frente a DKP.TRIS y frente a TRAM.HCl en su administración como agentes únicos en la fase de dosis única.

E.5.1.1

Timepoint(s) of evaluation of this end point

Over 8 hours after the first dose

A lo largo de las 8 horas siguientes a la primera dosis

E.5.2

Secondary end point(s)

Pain intensity
-Mean PI-VAS scores at rest, over 8 hours after the first dose.
-Percentage of responders (response defined as achievement of a mean PI-VAS < 40 mm at rest) at 2, 4, 6, 8 hours after the first dose.
-Mean SPID at rest, over 2, 4 and 6 hours after the first dose (SPID2, SPID4, SPID6).
-Mean % max SPID at rest, over 2, 4, 6 and 8 hours after the first dose (max SPID calculated as the theoretical maximum weighted sum of the PID-VAS values).
-Mean PI-VAS scores at rest over 48 hours of the multiple-dose phase.
-Percentage of responders (response defined as achievement a mean PI-VAS < 40 mm), over 48 hours of the multiple-dose phase.
-Mean SPID, over 24 and 48 hours of the multiple-dose phase.
-Mean % max SPID, over 24 and 48 hours of the multiple-dose phase.
Pain relief
-Mean PAR-VRS scores, over 8 hours after the first dose.
-Mean TOTPAR, calculated as the weighted sum of the PAR-VRS scores, over 4, 6 and 8 hours after the first dose (TOTPAR4, TOTPAR 6, TOTPAR8).
-Percentage of responders over 8 hours after the first dose, according to the 50 % maximum total pain relief rule (max TOTPAR calculated as the theoretical maximum weighted sum of the PAR-VRS scores).
Rescue medication
-Time to first use of RM: time elapsed between treatment administration and first RM intake.
-Use of RM (i.e. patients who require at least one dose of RM and amount of RM consumption) overall and over 24 and 48 hours of the multiple-dose phase.
Others
-PGE at the end of the single-dose phase (t8h); and during the multiple-dose phase on day 3 and day 5, eight hours after the morning dose, or whenever patient withdraws from the treatment.
-Worst pain while moving experienced in the previous 24 hours, on day 2 and on day 3.
-Discontinuation from the treatment for any cause (e.g. lack of efficacy, AEs, others).

Intensidad del dolor
- Puntuaciones medias en la PI-VAS en reposo, a lo largo de las 8 horas siguientes a la primera dosis.
-Porcentaje de pacientes que responden (definiéndose la respuesta como la consecución de un valor medio en PI-VAS < 40 mm en reposo) a las 2, 4, 6 y 8 horas después de la primera dosis.
-Valor medio de la SPID en reposo, a lo largo de 2, 4 y 6 horas después de la primera dosis (SPID2, SPID4, SPID6).
-Media del valor % máx de la SPID en reposo, a lo largo de 2, 4, 6 y 8 horas después de la primera dosis (valor máx de la SPID calculado como la suma ponderada máxima teórica de los valores de IDD-VAS).
- Puntuaciones medias de PI-VAS en reposo a lo largo de 48 horas de la fase de dosis repetidas.
-Porcentaje de respondedores (definiéndose la respuesta como la consecución de un valor medio en PI-VAS < 40 mm), a lo largo de 48 horas de la fase de dosis repetidas.
- Valor medio de la SPID, a lo largo de 24 y 48 horas de la fase de dosis repetidas
- Media del valor % máx de la SPID, a lo largo de 24 y 48 horas de la fase de dosis repetidas
Alivio del dolor
- Puntuaciones medias de PAR-VRS, a lo largo de 8 horas después de la primera dosis.
- Valor medio del TOTPAR, calculado como la suma ponderada de las puntuaciones del PAR-VRS, a lo largo de 4, 6 y 8 horas después de la primera dosis (TOTPAR4, TOTPAR 6, TOTPAR8).
- Porcentaje de pacientes con respuesta a lo largo de 8 horas después de la primera dosis, de acuerdo a la regla del 50% del alivio total máximo del dolor (máx del TOTPAR calculado como la suma ponderada máxima teórica de las puntuaciones del PAR-VRS).
Medicación de rescate
- Tiempo hasta el primer uso de MR: tiempo transcurrido entre la administración del tratamiento y la primera toma de MR.
- Uso de MR (es decir, pacientes que precisan como mínimo una dosis de MR y cantidad de consumo de MR) total y a lo largo de 24 y 48 horas de la fase de dosis repetidas.
Otros
- PGE al final de la fase de dosis única (t8h); y durante la fase de dosis repetidas el día 3 y el día 5, ocho horas después de la dosis matutina o cuando el paciente abandone el tratamiento.
-Peor dolor en movimiento experimentado en las 24 horas previas, el día 2 y el día 3.
- Abandono del tratamiento por cualquier causa (por ejemplo, falta de eficacia, acontecimiento adverso, otras).

E.5.2.1

Timepoint(s) of evaluation of this end point

see timepoints in the text above

Ver timepoints en el texto superior

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

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

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

China

Czech Republic

Germany

Hungary

India

Lithuania

Poland

Serbia

Spain

Taiwan

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

LPLV

Última visita 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

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:

200

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

400

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

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

600

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)

Patients who end their participation tin the trial will be treated according to current standard of care.

Los pacientes que terminan su participación en el ensayo serán tratados de acuerdo con la práctica clínica habitual

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

2013-04-02

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-03-15

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

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IMP with orphan designation in the indication
Orphan Designation Number:
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