Clinical Trials Register

Summary
EudraCT Number:	2006-002033-21
Sponsor's Protocol Code Number:	NKV102551
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:	2006-07-18
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

2006-002033-21

A.3

Full title of the trial

Estudio Fase III, multicéntrico, aleatorizado, doble ciego, con control activo, de grupos paralelos, para investigar la eficacia y seguridad de las formulaciones intravenosa y oral del antagonista de receptores de neuroquinina-1, casopitant, administradas en combinación con ZOFRAN y dexametasona, para la prevención de náuseas y vómitos inducidos por la quimioterapia en pacientes con neoplasias que van a recibir quimioterapia altamente emetógena con cisplatino.

A.4.1

Sponsor's protocol code number

NKV102551

A.7

Trial is part of a Paediatric Investigation Plan

Information not present in EudraCT

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	GlaxoSmithKline 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
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation
B.5.2	Functional name of contact point

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	GW679769 Powder for Injection 90mg/vial
D.3.2	Product code	GW679769
D.3.4	Pharmaceutical form	Powder for infusion*
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	414910-30-8
D.3.9.2	Current sponsor code	GW679769
D.3.9.3	Other descriptive name	Casopitant
D.3.10	Strength
D.3.10.1	Concentration unit	mg/g milligram(s)/gram
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	90
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)	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.8	Extractive medicinal product	Information not present in EudraCT
D.3.11.9	Recombinant medicinal product	Information not present in EudraCT
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	GW679769 Tablets 50mg
D.3.2	Product code	GW679769
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	414910-30-8
D.3.9.2	Current sponsor code	GW679769
D.3.9.3	Other descriptive name	Casopitant
D.3.10	Strength
D.3.10.1	Concentration unit	mg/g milligram(s)/gram
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)	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.8	Extractive medicinal product	Information not present in EudraCT
D.3.11.9	Recombinant medicinal product	Information not present in EudraCT
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	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	GW679769 Tablets 150mg
D.3.2	Product code	GW679769
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	414910-30-8
D.3.9.2	Current sponsor code	GW679769
D.3.9.3	Other descriptive name	Casopitant
D.3.10	Strength
D.3.10.1	Concentration unit	mg/g milligram(s)/gram
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	150
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)	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.8	Extractive medicinal product	Information not present in EudraCT
D.3.11.9	Recombinant medicinal product	Information not present in EudraCT
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: 4
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	Yes
D.2.1.1.1	Trade name	Zofran Injection Premixed
D.2.1.1.2	Name of the Marketing Authorisation holder	GlaxoSmithKline
D.2.1.2	Country which granted the Marketing Authorisation	United States
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	Zofran Injection Premixed
D.3.2	Product code	Zofran
D.3.4	Pharmaceutical form	Intravenous infusion
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
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	Ondansetron
D.3.9.1	CAS number	116002-70-1
D.3.9.3	Other descriptive name	Zofran
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	32
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)	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.8	Extractive medicinal product	Information not present in EudraCT
D.3.11.9	Recombinant medicinal product	Information not present in EudraCT
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: 5
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	Yes
D.2.1.1.1	Trade name	Dexamethasone
D.2.1.1.2	Name of the Marketing Authorisation holder	Galen
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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	Dexamethasone
D.3.2	Product code	Dexamethasone
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
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	Dexamethasone
D.3.10	Strength
D.3.10.1	Concentration unit	mg/g milligram(s)/gram
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	4
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)	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.8	Extractive medicinal product	Information not present in EudraCT
D.3.11.9	Recombinant medicinal product	Information not present in EudraCT
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	Powder for infusion*
D.8.4	Route of administration of the placebo	Intravenous use
D.8 Placebo: 2
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: 3
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: 4
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Tablet
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

Náuseas y vómitos inducidos por quimioterapia de poder emetogeno elevado.

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

El objetivo primario de este estudio es demostrar la superioridad de la terapia triple con casopitant, ZOFRAN y dexametasona, sobre la terapia doble con ZOFRAN y dexametasona, para la prevención de la emesis durante las 120 horas siguientes al inicio del primer ciclo de quimioterapia con cisplatino altamente emetógena (QAE).

E.2.2

Secondary objectives of the trial

Determinar si la adición de casopitant mejora
la prevención de la emesis en las fases aguda (0-24 h) y tardía (24-120 h) tras el primer ciclo de QAE.
la prevención de la emesis en las fases aguda (0-24 h), tardía (24-120 h) y global (0-120 h) tras los ciclos subsiguientes de QAE.
el control de las náuseas durante las 120 primeras horas y en las fases aguda y tardía después de cada ciclo de QAE.
Cuantificar el impacto de los regímenes antieméticos sobre las actividades cotidianas, evaluado con el cuestionario Functional Living Index-Emesis (FLIE) tras el primer ciclo de QAE.
Evaluar la satisfacción del sujeto con el régimen antiemético profiláctico y su disposición a utilizar el mismo régimen en futuros tratamiento quimioterápicos.
Determinar la seguridad y la tolerabilidad de casopitant cuando se administra como parte del régimen antiemético descrito en este protocolo

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Sujetos que comprendan la naturaleza y el objetivo de este estudio y los procedimientos del estudio y hayan dado su consentimiento informado por escrito confirmandolo.
2. Hombres o mujeres de al menos 18 años de edad.
3. Sujetos con diagnóstico de tumor sólido maligno que tengan previsto recibir su primer ciclo de quimioterapia citotóxica con cisplatino administrada como una dosis intravenosa única de 70mg/m2 durante 1-4 horas el Día 1, solo o en combinación con otros quimioterápicos. En los regímenes de combinación, los fármacos distintos de cisplatino de bajo-alto potencial emético deben administrarse después del cisplatino y completarse no más de 6 horas después del inicio de la infusión de cisplatino. Los taxanos sólo pueden administrarse el Día 1 del estudio.
4. Estado funcional ECOG de 0, 1 ó 2.
5. Sujetos con un estado hematológico y metabólico adecuado para recibir un régimen de cisplatino altamente emetógeno y que cumplan los siguientes criterios:
- Neutrófilos totales 1500/mm3 (unidades estándar: 1,5 x 109/l)
- Plaquetas 100.000/mm3 (unidades estándar: 100 x 109/l)
- Bilirrubina 1,5 x LSN
- Creatinina sérica 1,5mg/dl (unidades estándar: 132,6mol/l)
O
- Aclaramiento de creatinina 60ml/min
- Los valores de las enzimas hepáticas deben estar por debajo de los siguientes límites
Sin metástasis hepáticas conocidas: aspartato aminotransferasa (AST) y/o alanina aminotransferasa (ALT) 2,5 x límite superior normal
Con metástasis hepática conocidas: AST y/o ALT 5,0 x límite superior normal
6. Sujetos dispuestos y capaces de completar el diario del sujeto en cada ciclo del estudio.
7. Las mujeres potencialmente fértiles deben estar de acuerdo en utilizar correctamente un método anticonceptivo aceptable; los métodos anticonceptivos aceptables para GSK, cuando se utilicen siempre y de acuerdo con las instrucciones del médico y del prospecto.

E.4

Principal exclusion criteria

1. Ha recibido anteriormente quimioterapia citotóxica. Los tratamientos hormonales o biológicos previos están permitidos.
2. Tiene previsto recibir tratamiento con cisplatino más de un día durante un único ciclo de terapia.
3. Mujeres embarazadas o en período de lactancia.
4. Ha presentado vómitos o náuseas significativas (ejemplo, 25mm en una EAV) tras la administración de quimioterapia de bajo potencial emetógeno en los 6 días anteriores a la infusión de cisplatino.
5. Ha recibido radioterapia en tórax, abdomen o pelvis en los 10 días anteriores a la administración de la primera dosis de medicación del estudio y/o recibirá radioterapia en abdomen o pelvis en los 6 días siguientes a la primera dosis de medicación del estudio.
6. Ha experimentado emesis (es decir vómitos y/o arcadas) en las 24 horas anteriores a la administración de la primera dosis de medicación del estudio.
7. Ha presentado náuseas clínicamente significativas (ejemplo, 25mm en una EAV) en las 24 horas anteriores a la administración de la primera dosis de medicación del estudio.
8. Presenta un tumor maligno primario o metastásico en el sistema nervioso central, a menos que haya sido tratado con éxito mediante extirpación o radiación y posteriormente haya permanecido estable al menos durante 1 semana antes de recibir la primera dosis de medicación del estudio.
9. Tiene historia de enfermedad ulcerosa péptica documentada (a través de endoscopia o radiografía), enfermedad ulcerosa péptica activa, obstrucción gastrointestinal, carcinoma gástrico, aumento de la presión intracraneal, hipercalcemia o cualquier otra enfermedad (distinta del cáncer) que, a juicio del investigador, pueda confundir los resultados del estudio, representar otra potencial etiología para emesis y náuseas (distinta de las NVIQ) o supone un riesgo injustificado para el sujeto.
10. Tiene hipersensibilidad o una contraindicación conocida a ZOFRAN, otro antagonista de los receptores 5-HT3, dexametasona o cualquiera de los componentes de casopitant.
11. Ha recibido anteriormente un antagonista de los receptores NK-1.
12. Tiene una infección sistémica activa o una enfermedad no controlada
13. Está recibiendo o tiene previsto recibir tratamiento sistémico con corticosteroides a cualquier dosis en las 72 horas anteriores a la primera dosis de la medicación del estudio, excepto cuando estén indicados como premedicación para un taxano. Sin embargo, los esteroides tópicos y los corticosteroides inhalados con una dosis de esteroide 10mg diarios de prednisona o equivalente, están permitidos.
14. Tiene previsto recibir un transplante de médula ósea y/o tratamiento de rescate con células madre con este ciclo de terapia con cisplatino.
15. Ha recibido un fármaco en investigación en los 30 días o cinco semividas (lo que sea más largo) anteriores a la primera dosis de la medicación del estudio, y/o tiene previsto recibir cualquier fármaco en investigación durante el estudio.
16. Ha recibido medicación moderadamente y/o altamente emetógena en las 48 horas anteriores a la primera dosis de la medicación del estudio. (Los narcóticos opiáceos para el tratamiento del dolor producido por el cáncer estarán permitidos si el sujeto ha estado con dicha medicación al menos durante 7 días y no ha presentado náuseas o emesis a causa de ellos).

17. Ha tomado/recibido cualquier medicación con actividad antiemética potencial o conocida en el periodo de 24 horas anterior a la administración del fármaco del estudio. Esto incluye, pero no se limita a:
- antagonistas de los receptores 5-HT3. El palonestrón no está permitido en los 7 días anteriores a la administración del producto en investigación.
- benzamida/derivados de la benzamida
- benzodiazepinas (excepto si el sujeto está recibiendo dicha medicación para dormir o para tratamiento de la ansiedad y ha estado con una dosis estable al menos durante 7 días antes de recibir la primera dosis del producto en investigación GW679769; sin embargo, el lorazepam está prohibido).
- fenotiazinas, butirofenona, corticosteroides, anticolinérgicos, antihistamínicos, domperidoma, mirtazapina, olanzapina, cannabinoides
18. Ha tomado/recibido potentes o moderados inhibidores del CYP3A4 y del CYP3A5
19. Ha tomado/recibido inductores del CYP3A4 y del CYP3A5 en los 14 días anteriores a la administracióndel casopitant.
20. Está tomando el antidiabético repaglinida o el diurético torsemida. Se aconseja a los investigadores que tengan cuidado si incluyen sujetos que estén tomando los antidiabéticos rosiglitazona o pioglitazona, o antipalúdicos como cloroquina o amodiaquina, porque el metabolito de casopitant es un potencial inhibidor del CYP2C8.

E.5 End points

E.5.1

Primary end point(s)

La variable primaria será la proporción de sujetos que alcanzan una respuesta completa (definida como ausencia de vómitos y arcadas y sin tratamiento de rescate) durante las 120 horas siguientes al inicio del primer ciclo de quimioterapia altamente emetógena con cisplatino

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

Yes

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

Yes

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Quality of life

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

Information not present in EudraCT

E.7.1.1

First administration to humans

Information not present in EudraCT

E.7.1.2

Bioequivalence study

Information not present in EudraCT

E.7.1.3

Other

Information not present in EudraCT

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Information not present in EudraCT

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

Information not present in EudraCT

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.8.3

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.8.5

The trial involves multiple Member States

Yes

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

Information not present in EudraCT

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

E.8.7

Trial has a data monitoring committee

Information not present in EudraCT

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

LSLV

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

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

Information not present in EudraCT

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

Information not present in EudraCT

F.1.1.3

Newborns (0-27 days)

Information not present in EudraCT

F.1.1.4

Infants and toddlers (28 days-23 months)

Information not present in EudraCT

F.1.1.5

Children (2-11years)

Information not present in EudraCT

F.1.1.6

Adolescents (12-17 years)

Information not present in EudraCT

F.1.2

Adults (18-64 years)

Yes

F.1.3

Elderly (>=65 years)

Yes

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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2006-07-18.

Yes

F.3.3.2

Women of child-bearing potential using contraception

Information not present in EudraCT

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

355

F.4.2.2

In the whole clinical trial

810

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)

No está planeado que se ofrezca el producto en investigación a los participantes del estudio en cuando haya finalizado. GW679769 actualmente no tiene autorización de comercialización en ningún páís. Después de completar el estudio, el médico será el responsable de asegurar que el sujeto reciba los cuidados y tratamientos apropiados

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

2006-09-07

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2006-08-09

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2007-10-09

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Orphan Designation Number:
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