Clinical Trials Register

Summary
EudraCT Number:	2012-005115-13
Sponsor's Protocol Code Number:	ICOL121
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:	2013-01-09
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

2012-005115-13

A.3

Full title of the trial

A randomized, assessor-blinded, multicenter, international study investigating efficacy, patient's acceptance, safety and tolerability of Sodium Phosphate tablets compared to split dose Polyethylene Glycol for colon cleansing prior to colonoscopy.

Estudio internacional, multicéntrico, aleatorizado, con evaluador ciego para la investigación de la eficacia, aceptación del paciente, seguridad y tolerabilidad de comprimidos de Fosfato sódico comparado con dosis dividida de Polietilenglicol en la limpieza de colon antes de realizar una colonoscopia.

A.3.1

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

A.4.1

Sponsor's protocol code number

ICOL121

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	LABORATOIRES MAYOLY SPINDLER
B.1.3.4	Country	France
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	Laboratoires Mayoly Spindler
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	NUVISAN ONCOLOGY SA
B.5.2	Functional name of contact point	Project Manager
B.5.3	Address:
B.5.3.1	Street Address	18-20 Rue Pasteur
B.5.3.2	Town/ city	Le Kremlin-Bicêtre
B.5.3.3	Post code	94278
B.5.3.4	Country	France
B.5.4	Telephone number	+33(0)145 15 40 75
B.5.5	Fax number	+33(0)145 15 40 61
B.5.6	E-mail	muriel.dembak@nuvisan.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	COLOKIT
D.2.1.1.2	Name of the Marketing Authorisation holder	Laboratoires Mayoly Spindler
D.2.1.2	Country which granted the Marketing Authorisation	France
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.3.4	Pharmaceutical form	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	SODIUM PHOSPHATE MONOBASIC MONOHYDRATE
D.3.9.1	CAS number	10049-21-5
D.3.9.3	Other descriptive name	SODIUM PHOSPHATE MONOBASIC MONOHYDRATE
D.3.9.4	EV Substance Code	SUB15834MIG
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	1102
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	SODIUM PHOSPHATE DIBASIC ANHYDROUS
D.3.9.1	CAS number	7558-79-4
D.3.9.3	Other descriptive name	SODIUM PHOSPHATE DIBASIC ANHYDROUS
D.3.9.4	EV Substance Code	SUB37384
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	398
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	KLEAN PREP
D.2.1.1.2	Name of the Marketing Authorisation holder	Norgine Limited
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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.3.4	Pharmaceutical form	Powder for oral solution in sachet
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	Polyethylene Glycol
D.3.9.1	CAS number	25322-68-3
D.3.9.3	Other descriptive name	Macrogol 3350
D.3.9.4	EV Substance Code	SUB20628
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	59
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Sodium Bicarbonate
D.3.9.1	CAS number	144-55-8
D.3.9.3	Other descriptive name	Sodium Bicarbonate
D.3.9.4	EV Substance Code	SUB12643MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	1.685
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Sodium Chloride
D.3.9.1	CAS number	7647-14-5
D.3.9.3	Other descriptive name	Sodium Chloride
D.3.9.4	EV Substance Code	SUB12581MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	1.465
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Potassium Chloride
D.3.9.1	CAS number	7447-40-7
D.3.9.3	Other descriptive name	Potassium Chloride
D.3.9.4	EV Substance Code	SUB12559MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0.7425
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Sodium Sulfate Anhydrous
D.3.9.1	CAS number	7757-82-6
D.3.9.3	Other descriptive name	Sodium Sulfate Anhydrous
D.3.9.4	EV Substance Code	SUB15326MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	5.685
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

Bowel cleansing to ensure the preparation of patient prior to colonic surgery or colon endoscopic or radiological diagnostic procedures

limpieza colónica, con el fin de garantizar la preparación de los pacientes antes de una cirugía colónica o diagnosis radiológica o endoscópica del colon

E.1.1.1

Medical condition in easily understood language

Bowel cleansing before colonoscopy

Limpieza de colon previa a colonoscopia.

E.1.1.2

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	PT
E.1.2	Classification code	10066943
E.1.2	Term	Bowel preparation
E.1.2	System Organ Class	10042613 - Surgical and medical procedures

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Assess the efficacy of sodium phosphate tablets versus split dose of 4 liters of PEG for bowel cleansing prior to colonoscopy.

Evaluar la eficacia de los comprimidos de fosfato sódico frente a la dosis dividida de 4 litros de PEG en la limpieza intestinal previa a la colonoscopia

E.2.2

Secondary objectives of the trial

Secondary objectives will include:
- patient's acceptability
- tolerability
- safety, in term of physical examination, vital signs, adverse events, and blood tests
- study medication compliance

Los objetivos secundarios incluirán la evaluación de:
- Aceptabilidad del paciente
- Tolerabilidad
- Seguridad, en términos de exploración física, signos vitales, acontecimientos adversos, y muestras de sangre
- Cumplimiento con la medicación del estudio.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

(1) Written informed consent form.
(2) Men and women aged from 18 to 75 years (included).
(3) Scheduled for a colonoscopy as an outpatient.
(4) Normal renal function (eGFR greater or equal to 60 mL/mn/1.73m2)

(1) Formulario de consentimiento informado por escrito.
(2) Hombres y mujeres de 18 a 75 años (incluidos)
(3) Programación de colonoscopia como paciente ambulatorio.
(4) Función renal normal (eGFR superior o igual a 60 mL/mn/1.73m2).

E.4

Principal exclusion criteria

(1) Pregnant woman or likely to be (without contraception) or breast feeding.
(2) Having a disease or condition as follows:
- clinically significant abnormal electrolytes values (sodium, phosphate, potassium, calcium),
- primary hyperparathyroidism associated with hypercalcemia,
- congestive heart failure Class III and IV (Am. Heart Assoc., NYHA Classification),
- unstable angina pectoris or recent myocardial infarction, PTCA or coronary artery bypass surgery within previous 3 months
- ascites,
- known/suspected bowel obstruction, megacolon, ileus or intestinal perforation, or gastroparesis,
- inflammatory bowel disease,
- history of gastric stapling or bypass procedure or gastric retention
- history of colonic resection, except partial resection of the sigmoid
- severe chronic constipation (< 2 bowel movements per week)
- swallowing difficulties
- any other clinical condition which, in the opinion of the investigator, would not allow the subject to participate in the study in good conditions.
(3) Sodium phosphate preparation taken within the past three weeks prior to colonoscopy.
(4) Drugs that affect renal perfusion or function, including diuretics, angiotensin converting enzyme (ACE) inhibitors and angiotensin receptors blockers or daily use of non-steroidal anti-inflammatory drugs (NSAIDs) (occasional NSAIDs use is permitted) initiated within 4 weeks prior to first study drug intake,
(5) Concomitant use of medications known to prolong the QT interval.
(6) Known allergy to any of the active ingredients or excipients of the study drugs.
(7) History of phenylketonuria
(8) Subjects who have participated in a clinical trial in the previous 30 days.
(9) Subjects deprived of freedom by judicial or administrative decision, hospitalized without their consent or for other reasons than the research, under legal protection or unable to express their consent.

(1) Mujeres embarazadas o con posibilidad de quedarse embarazadas (no usan anticonceptivos) o lactantes.
(2) Que tengan una enfermedad o condición como las que siguen:
- valores anormales de electrolitos clínicamente significativos (sodio, fosfato, potasio, calcio),
- hiperparatiroidismo primario asociado con hipercalcemia,
- insuficiencia cardiaca congestiva de Clase III y IV (Am. Heart Assoc., Clasificación NYHA),
- angina de pecho inestable o infarto reciente de miocardio, PTCA o bypass de la arteria coronaria dentro de los 3 meses previos,
- ascitis,
- conocimiento/ sospecha de obstrucción intestinal, megacolon, perforación intestinal o del íleo, o gastroparesia,
- enfermedad inflamatoria intestinal,
- historia de cirugía de banda gástrica o bypass o retención gástrica,
- historia de colectomía, excepto resección sigmoide parcial
- estreñimiento crónico severo (<2 movimientos intestinales por semana)
- dificultades de deglución
- cualquier otra condición clínica que, en opinión del investigador, no permitiese al sujeto participar en buenas condiciones en el estudio.
(3) Preparado de fosfato sódico tomado dentro de las tres semanas anteriores previas a la colonoscopia.
(4) Fármacos que afecten a la función o perfusión renal, incluyendo diuréticos, enzima convertidora de la angiotensina (ACE), inhibidores y bloqueantes de los receptores de la angiotensina o uso diario de fármacos antiinflamatorios no esteroideos (NSAIDs) (el uso ocasional de NSAIDs está permitido), que comiencen dentro de las 4 semanas antes de la primera toma del fármaco en estudio.
(5) Uso de medicaciones concomitantes que se sepa que prolongan el intervalo QT.
(6) Alergia conocida a alguno de los ingredientes activos o excipientes de los fármacos del estudio.
(7) Historia de fenilcetonuria.
(8) Sujetos que hayan participado en un ensayo clínico en los 30 días previos.
(9) Sujetos privados de libertad por decisión judicial o administrativa, hospitalizados sin su consentimiento o por otras razones distintas de la investigación, bajo protección legar o incapaces de otorgar su consentimiento.

E.5 End points

E.5.1

Primary end point(s)

Efficacy: Quality Score of bowel preparation with Boston Bowel Preparation Scale (BBPS)

Eficacia: Puntuación de limpieza global de la Escala de Preparación Intestinal de Boston (BBPS).

E.5.1.1

Timepoint(s) of evaluation of this end point

During the colonoscopy

Durante la colonoscopia

E.5.2

Secondary end point(s)

Efficacy:
- Proportion of patients with 'adequate' cleansing for the right colon segment (segment score > or = to 2).
- Proportion of patients with 'adequate' cleansing for the transverse colon segment (segment score > or = to 2).
- Proportion of patients with 'adequate' cleansing for the left colon segment (segment score > or = to 2).
- Proportion of completed colonoscopies (intubation of the cecum) and proportion of rescheduled colonoscopies.
- Relationship of the BBPS score and the percentage of patients who completed the colonoscopy (intubation of the cecum).
- Polyps detection rate (percentage of patients with at least one polyp detected).
- Polyps detection rate by location (colon segment).
- Mean number of polyps per patient detected per size (< 5 mm / 5-<10 mm / > or = to 10 mm).

Acceptability:
- Proportion of patients with 'very acceptable' acceptability, based on a 4-points Likert scale.
- Proportion of patients willing to repeat the same bowel preparation.
- Proportion of patients who assessed the product taste as 'no taste', based on a 4-points Likert scale.
- Proportion of patients who assessed the easiness to take the product as 'easy', based on a 4-points Likert scale.

Tolerability:
- Proportion of patients experiencing nausea, vomiting, abdominal pain, abdominal bloating.
- Severity of nausea, vomiting, abdominal pain, abdominal bloating using a 4-point Likert scale.

Compliance:
- Patient's compliance based on the assessment of study drug intake.

Safety:
Proportion of patients with TEAEs by System and Organ Class (SOC) and Preferred Term (PT) using MedDRA terminology.
Diarrhoea is an expected outcome of study drug with bowel preparation, will not be captured as an adverse event unless it is a serious adverse event.
It is also expected that some cancers will be detected during colonoscopy; these will not be considered as serious adverse events.
Polyps and diverticuli found during the colonoscopy will not be considered as adverse events, because they are part of the objectives of the colonoscopy.

Eficacia:
- Proporción de pacientes con limpieza 'adecuada' del segmento derecho del colon (puntuación del segmento > o = 2).
- Proporción de pacientes con limpieza 'adecuada' del segmento transverso del colon (puntuación del segmento > o = 2).
- Proporción de pacientes con limpieza 'adecuada' del segmento izquierdo del colon (puntuación del segmento > o = 2).
- Proporción de colonoscopias completas (intubación cecal) y proporción de colonoscopias reprogramadas.
- Relación entre la puntuación BBPS y el porcentaje de pacientes que hayan completado la colonoscopia (intubación cecal).
- Tasa de detección de pólipos (porcentaje de pacientes con al menos un pólipo detectado)
- Tasa de detección de pólipos por localización (segmento del colon).
- Número medio de pólipos por paciente detectados por tamaño (< 5 mm / 5-<10 mm / > o = 10 mm).

Aceptabilidad:
- Proporción de pacientes con una aceptabilidad 'muy aceptable', basada en una escala Likert de 4 puntos.
- Proporción de pacientes que deseen repetir la misma preparación intestinal.
- Proporción de pacientes que evalúen el sabor del producto como 'sin sabor', basado en una escala Likert de 4 puntos.
- Proporción de pacientes que evalúen la facilidad de tomar el producto como 'fácil', basado en una escala Likert de 4 puntos.

Tolerabilidad:
- Proporción de pacientes que presenten nausea, vómitos, dolor abdominal, inflamación abdominal.
- Intensidad de la náusea, vómitos, dolor abdominal, inflamación abdominal usando una escala Likert de 4 puntos.

Cumplimiento:
- El cumplimiento de los pacientes se basa en la evaluación de la ingesta de la medicación del estudio.

Seguridad:
Proporción de pacientes con TEAEs por sistema orgánico (SOC) y término preferente (PT) usando la terminología MedDRA.
No se registrará la diarrea como acontecimiento adverso a no ser que se trate de un acontecimiento adverso grave, ya que es una consecuencia lógica de la medicación del estudio en la preparación intestinal.
Los pólipos o diverticulitis encontrados durante la colonoscopia no se considerarán acontecimientos adversos, porque son parte de los objetivos de la colonoscopia. Asimismo se espera que se detecten algunos cánceres durante la colonoscopia; éstos no se considerarán como acontecimientos adversos graves.

E.5.2.1

Timepoint(s) of evaluation of this end point

From the start of drug intake through visit 4

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

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

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

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

Última visita del último paciente

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

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:

224

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

224

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

F.3.3.2

Women of child-bearing potential using contraception

Yes

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

168

F.4.2

For a multinational trial

F.4.2.1

In the EEA

448

F.4.2.2

In the whole clinical trial

448

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

2013-02-22

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-02-15

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

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Clinical trials