Clinical Trials Register

Summary
EudraCT Number:	2006-006175-20
Sponsor's Protocol Code Number:	UC-0110/0608
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2012-12-17
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2006-006175-20

A.3

Full title of the trial

Systemic Chemotherapy With or Without Intraperitoneal Chemohyperthermia in Treating Patients Undergoing Surgery for Peritoneal Carcinomatosis From Colorectal Cancer

Ensayo en fase III evaluando la función de la quimiohipertermia intraperitoneal intraoperatoria (CHIP) después de una resección máxima en carcinomatosis peritoneal de origen colorrectal asociado con quimioterapia sistémica.

A.3.1

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

Systemic Chemotherapy With or Without Intraperitoneal Chemohyperthermia in Treating Patients Undergoing Surgery for Peritoneal Carcinomatosis From Colorectal Cancer

A.3.2

Name or abbreviated title of the trial where available

PICH

CHIP

A.4.1

Sponsor's protocol code number

UC-0110/0608

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	UNICANCER
B.1.3.4	Country	France
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	UNICANCER
B.4.2	Country	France
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Unicancer
B.5.2	Functional name of contact point	BEATA JUZYNA
B.5.3	Address:
B.5.3.1	Street Address	101 rue de Tolbiac
B.5.3.2	Town/ city	PARIS
B.5.3.3	Post code	75013
B.5.3.4	Country	France
B.5.4	Telephone number	+33144 23 55 67
B.5.5	Fax number	+33144 23 55 69
B.5.6	E-mail	b-juzyna@unicancer.fr

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	Yes
D.2.1.1.1	Trade name	ELOXATINE®
D.2.1.1.2	Name of the Marketing Authorisation holder	SANOFI AVENTIS SA
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	ELOXATINE®
D.3.2	Product code	NON APPLICABLE
D.3.4	Pharmaceutical form	Powder for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intraperitoneal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Oxaliplatine
D.3.9.1	CAS number	NA
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	NA
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	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.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	Yes
D.2.1.1.1	Trade name	FOLINATO CÁLCICO
D.2.1.1.2	Name of the Marketing Authorisation holder	LABORATORIOS NORMON 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	Calcium Lévofolinate
D.3.4	Pharmaceutical form	Powder for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous drip use (Noncurrent)
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Acide folinique
D.3.9.1	CAS number	NA
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	NA
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	10
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	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	FLUOROURACILO
D.2.1.1.2	Name of the Marketing Authorisation holder	FERRER FARMA, 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	Fluorouracile
D.3.2	Product code	NA
D.3.4	Pharmaceutical form	Solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous bolus use (Noncurrent)
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Fluorouracile
D.3.9.1	CAS number	NA
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	NA
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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Patients Undergoing Surgery for Peritoneal Carcinomatosis From Colorectal Cancer

Pacientes que tendrán una cirugía de citoreducción máxima por una carcinomatosis peritoneal de origen colorrectal

E.1.1.1

Medical condition in easily understood language

Patients Undergoing Surgery for Peritoneal Carcinomatosis From Colorectal Cancer

Pacientes que tendrán una cirugía de citoreducción máxima por una carcinomatosis peritoneal de origen colorrectal

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

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	10052171
E.1.2	Term	Peritoneal carcinoma
E.1.2	System Organ Class	100000004864

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 compare the overall survival in patients affected with peritoneal carcinosis of
colorectal origin and having undergone a macroscopically complete or suboptimal (with unresected residual tumor tissues ? 1mm) surgical resection and benefiting from a maximized treatment with chemotherapy (i.e.: maximal surgery + chemohyperthermia + pre- or post-operatory systemic chemotherapy) or a maximized treatment without chemohyperthermia (i.e.: maximal surgery + pre-or post-operatory systemic chemotherapy).

Comparar la supervivencia global en pacientes con carcinomatosis peritoneal de origen colorrectal que hayan sido sometidos a una cirugía citoreductora completa macroscópicamente o subóptima (residuo tumoral menor de 1 mm) , complementándola con quimiohipertermia y quimioterapia sistémica o bien , sólo con quimioterapia sistémica.

E.2.2

Secondary objectives of the trial

?Evaluate recurrence-free survival of these patients.
?Evaluate treatment toxicities.
?Determine morbidity from surgical complications.
?Determine prognostic factors of survival.

- Evaluar la supervivencia sin recidiva
-Evaluar la toxicidad del tratamiento (CTC-AE v3.0)
-Evaluar la tasa de morbilidad
-Evaluar los factores pronósticos de supervivencia

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

nutrition and digestive surgery study: aim:
patient nutrition evaluation treated for a peritoneal carcinomatosis before and 3 months after the surgery.
Correlation between nutritional status and complications
to mesure specific morbidity
To study patient evolution

-Estudio sobre nutrición y cirugía digestiva: objetivos:
-evaluación nutricional de los pacientes en tratatmiento por una carcinomatosis peritoneal antes y 3 meses después de la cirugía
-Correlación entre estado nutricional y complicaciones
-Medir la morbilidad más específicamente
-Estudiar la evolución de los pacientes

E.3

Principal inclusion criteria

1) Histologically confirmed colorectal cancer,
2) Minimal or moderate peritoneal carcinosis with a Sugarbaker peritoneal score ? à 25 (see
annex 9), (peroperatory assessment),
3) A surgically obtained tumor reduction, macroscopically complete R1 or with a residual
thickness not exceeding 1 mm (R2), (peroperatory assessment)
4) Absence of extra peritoneal metastases including hepatic and pulmonary metastases (
confirmed by a PET scan, if possible),
5) Patient to be treated by systemic chemotherapy for its carcinosis,
6) 18 ? age ? 70 yo,
7) WHO performance status ? 1,
8) Life expectancy > 12 weeks,
9) Adequate hematological function: polynuclear neutrophiles ? 1,5x10
9
/L, platelets ? 100x10
9
/L,
10) Adequate hepatic function : total bilirubin ? 1,5 x ULN, ASAT (SGOT) and ALAT (SGPT) ? 3 x
ULN, alkaline phosphatases ? 3 x ULN,
11) Seric creatinine ? 1,25 x ULN,
12) Operable patient,
13) Peripheral neuropathy with grade ? 3 (CTC AE v3.0 annex 7)
14) Patient information and written informed consent form signed before any protocol specific
procedure is started.
15) Patient is affiliated with a proper/French national health insurance fund

1) Cáncer colorrectal histológicamente demostrado
2) Carcinomatosis peritoneal de extensión leve o moderada , con un Score de extensión peritoneal de Sugarbaker menor a 25( Anexo 9) ( Evaluación intraoperatoria)
3) La obtención de una citorreducción quirúrgica macroscópicamente completa ( R1 ) o residuo tumoral no superior a 1 mm (R2), (evaluación intraoperatoria)
4) Ausencia de metástasis extraperitoneales, incluyendo metástasis hepáticas y pulmonares(si es posible confirmadas por la práctica de un PET)
5) Haber recibido tratamiento con quimioterapia sistémica.
6) Edad comprendida entre 18 y 70 años
7) Performance status OMS ≤ 1
8) Esperanza de vida> 12 semanas
9) Función hematológica: PNN ≥1,5 x 109/L, plaquetas 100x109/L,
10) Función hepática: bilirrubina total sin sobrepasar 1.5 veces los valores normales, AST (SGOT) y ALT (SGPT) sin sobrepasar 3 veces los valores normales.
11) creatinina plasmática sin sobrepasar 1.25 veces los valores normales.
12) Pacientes operables
13) Neuropatía periférica de grado 3 (CTC AE v 3.0, Anexo 7)
14) Información al paciente y firma de un consentimiento informado antes de cualquier procedimiento especifico del estudio
15) Afiliación a un régimen de seguridad social.

E.4

Principal exclusion criteria

1) Carcinosis of other-than-colorectal origin, specifically appendiculary carcinomas,
2) Large volume carcinosis with Sugarbaker peritoneal-extent score >25 (annex 9), (peroperatory
assessment)
3) Patient has already been treated by chemohyperthermia
4) History of previous cancer (except cutaneous basocellular carcinoma or in situ carcinoma of
the uterine cervix) with a relapse occurred within the 5-year period prior to inclusion,
5) Patient already included in another first-line therapeutic trial aimed at the same disease study,
6) Pregnant women, women who are likely to become pregnant or are breast-feeding,
7) Individual deprived of liberty or placed under the authority of a tutor,
8) Patients with any psychological, familial, sociological or geographical condition potentially
hampering compliance with the study protocol and follow-up schedule.

1) Carcinomatosis de cualquier otro origen, en particular el carcinoma apendicular.
2) Carcinomatosis peritoneal de extensión grave, con un Score de extensión peritoneal de Sugarbaker > 25 ( Anexo 9) (evaluación intraoperatoria)
3) Pacientes tratados previamente con quimiohipertermia
4) Antecedentes de cáncer (excepto el carcinoma de basocelular cutáneo o carcinoma in situ de cuello uterino) con recaída en los 5 años previos a la entrada en el estudio.
5) Paciente incluido en otro ensayo clínico de primera línea para la enfermedad estudiada
6) Embarazo (o sospecha del mismo), periodo de lactancia.
7) Las personas privadas de libertad o bajo tutela,
8) Incapacidad para someterse a examen médico por razones geográficas, sociales o psicológicas.

E.5 End points

E.5.1

Primary end point(s)

Overall survival will be taken into account. Estimate of the median survival is 30 months in the
control group. The trial objective is to increase the median survival time to 48 months using the
experimental treatment PICH (hazard ratio = 0.625).

Se evaluará principalmente la supervivencia global. La media de supervivencia está estimada en 30 meses en el grupo control. El objetivo es aumentar la media de supervivencia hasta alcanzar los 48 meses en el tratamiento experimental CHIP (hasard ratio= 0,625)

E.5.1.1

Timepoint(s) of evaluation of this end point

7 years

7 años

E.5.2

Secondary end point(s)

Survival without relapse : the following cases will be considered as relapse :
- Histologically confirmed relapse or a suggestive context (palpable nodules, visible on
imaging, with concomitant elevation of significant markers)
- Distant relapse (evident on imaging or Histologically confirmed),
- Any patient's death.

Treatment toxicity : according to the CTC AE v3.0 scale (annex 7)
Surgical complications :
- Abdominal complications : (digestive fistula, urinary fistula, deep abscess without fistula,
hemoperitoneum, number of percutaneous drainages)
- Extra-abdominal complications: (pulmonary, infectious urinary, central catheter infection,
venous (thrombo-embolic), parietal, renal insufficiency, cardiac disorders)
- Aplasia: postoperatory, febrile aplasia or other non-febrile complications.

Morbidity :
- Patients' deaths occurring within 60 days following surgery,
- Serious hemorrhages (> 30 % of blood volume),
- Serious hemodynamic impairments,
- Any visceral impairments, notably :
o Renal insufficiency or rhabdomyolysis requiring dialysis.
o Respiratory impairment requiring assisted ventilation = 2 days.
o Hepatic impairment: bilirubine > 10 N.
o Serious neurophysiological and motricity disorders.
- Parenteral feeding at home > 1 month,
- Any infectious complication (locoregional infection, abscess drainage?.)
- Grade 4 thrombopenia (< 25 000), Neutropenia < 500 PN, blood transfusion > 4 CG,
Diarrheas > 15 times/day and beyond D21, serious decrease of auditive capacity,
- Any SAE putting the vital prognosis at stake or causing permanent invalidity or
serious temporary incapacity.
-Survival prognostic factors

1- Supervivencia sin recidiva, siendo consideradas recidivas:
- Recidiva peritoneal demostrada histológicamente o contexto clínico muy sugestivo (Nódulos palpables o hallados en prueba de imagen con elevación concomitante de marcadores tumorales).
- Recidiva a distancia (evidente en la iconografía o comprobada histológicamente)
- Las muertes por todas las causas.
2- La toxicidad del tratamiento: de acuerdo con CTC AE v3.0 (Anexo 7)
3- Complicaciones quirúrgicas:
- Complicaciones abdominales (Fístula digestiva, fístula urinaria, absceso profundo sin fístula, hemoperitoneo, número de drenajes percutáneos)
- Complicaciones extra-abdominales: (pulmonares, infección urinaria, infección del catéter central, venosas (tromboembolismo), parietal, insuficiencia renal, cardiacas)
- Aplasia postoperatoria, aplasia febril o complicaciones no febriles.
3- Morbilidad:
- Mortalidad en los 60 días después de la cirugía,
- Sangrado severo (> 30% del volumen sanguíneo)
- Inestabilidad hemodinámica severa,
- Toda insuficiencia orgánica, en especial,
Insuficiencia renal o rabdomiolisis que requiera diálisis
Fracaso respiratorio que requiera ventilación asistida = 2 días
Insuficiencia hepática : bilirrubina> 10 N.
Alteraciones cerebro-motoras graves
- Nutrición parenteral > 1 mes a domicilio
- Cualquier complicación infecciosa (infección locorregional, drenaje de abscesos ....)
- Trombocitopenia grado 4 (<25 000), neutropenia <500 PN, transfusión> 4 concentrados de hematíes, diarrea > 15 deposiciones / día más allá del día 21 hipoacusia severa
-Todos los efectos adversos graves que comprometan la vida o provoquen una invalidez permanente o una incapacidad temporal grave.
4- Factores pronósticos de supervivencia

E.5.2.1

Timepoint(s) of evaluation of this end point

7 years

7 años

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

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

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)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

maximal surgery without chemohyperthermia

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the 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

Yes

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

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

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.1.2.1

Number of subjects for this age range:

220

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

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

Information not present in EudraCT

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

Information not present in EudraCT

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

264

F.4.2.2

In the whole clinical trial

264

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)

Medical control every 6 months

controles médicos cada 6 meses

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

2013-04-08

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-03-26

P. End of Trial
P.	End of Trial Status	Ongoing

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