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    Summary
    EudraCT Number:2012-005754-38
    Sponsor's Protocol Code Number:AOC-PSM-201301
    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:2013-03-06
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2012-005754-38
    A.3Full title of the trial
    Title : COMPARISON OF THE EFFECTIVENESS OF TWO PROTOCOLS FOR BOWEL CLEANING FOR CAPSULE ENDOSCOPY STUDIO
    Título: COMPARACIÓN DE LA EFECTIVIDAD DE DOS PROTOCOLOS DE LIMPIEZA INTESTINAL PARA EL ESTUDIO CON CAPSULA ENDOSCOPICA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    COMPARISON OF TWO DRUGS FOR BOWEL CLEANING FOR CAPSULE ENDOSCOPY STUDIO
    COMPARACIÓN DE DOS PRODUCTOS DE LIMPIEZA INTESTINAL PARA UN ESTUDIO DE CÁPSULA ENDOSCÓPICA
    A.4.1Sponsor's protocol code numberAOC-PSM-201301
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorHOSPITAL DE GALDAKAO-USANSOLO
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportDEPARTAMENTO DE SANIDAD DEL GOBIERNO VASCO - BIOEF
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDEPARTAMENTO DE SANIDAD DEL GOBIERNO VASCO-BIOEF
    B.5.2Functional name of contact pointOLATZ SABAS
    B.5.3 Address:
    B.5.3.1Street AddressPLAZA ASUA Nº 1
    B.5.3.2Town/ citySONDIKA
    B.5.3.3Post code48150
    B.5.3.4CountrySpain
    B.5.4Telephone number0034944536143
    B.5.5Fax number0034944530465
    B.5.6E-mailosabas@bioef.org
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Citrafleet
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratorios Casen Fleet
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameCitrafleet
    D.3.4Pharmaceutical form Powder for oral solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSODIUM PICOSULFATE
    D.3.9.1CAS number 10040-45-6
    D.3.9.4EV Substance CodeSUB10569MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMAGNESIUM OXIDE, LIGHT
    D.3.9.1CAS number 546-93-0
    D.3.9.3Other descriptive nameMAGNESIUM OXIDE, LIGHT
    D.3.9.4EV Substance CodeSUB12130MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3.5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCITRIC ACID ANHYDROUS
    D.3.9.1CAS number 77-92-9
    D.3.9.3Other descriptive nameCITRIC ACID ANHYDROUS
    D.3.9.4EV Substance CodeSUB29050
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10.97
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Moviprep
    D.2.1.1.2Name of the Marketing Authorisation holderNORGINE
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameMoviprep
    D.3.4Pharmaceutical form Powder for oral suspension
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPOLYETHYLENE GLYCOL 3350
    D.3.9.3Other descriptive namePOLYETHYLENE GLYCOL 3350
    D.3.9.4EV Substance CodeSUB20318
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSODIUM SULFATE ANHYDROUS
    D.3.9.1CAS number 7757-82-6
    D.3.9.3Other descriptive nameSODIUM SULFATE ANHYDROUS
    D.3.9.4EV Substance CodeSUB15326MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number7500
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSODIUM CHLORIDE
    D.3.9.3Other descriptive nameSODIUM CHLORIDE
    D.3.9.4EV Substance CodeSUB12581MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2691
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPOTASSIUM CHLORIDE
    D.3.9.3Other descriptive namePOTASSIUM CHLORIDE
    D.3.9.4EV Substance CodeSUB12559MIG
    D.3.10 Strength
    D.3.10.1Concentration unit d day
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1015
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNASCORBIC ACID
    D.3.9.2Current sponsor codeASCORBIC ACID
    D.3.9.4EV Substance CodeSUB05579MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4700
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSODIUM ASCORBATE
    D.3.9.3Other descriptive nameSODIUM ASCORBATE
    D.3.9.4EV Substance CodeSUB10549MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5900
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another 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.1.1Medical condition(s) being investigated
    We do not use these products in a concrete disease. We compare the effectiveness of these products to obtain an accurate bowel cleansing before performing a capsule endoscopic study.
    No usamos estos productos en una patología en concreto, sino que nuestro objetivo es comparar la eficacia de ambos para obtener una adecuada limpieza intestinal en aquellos pacientes que van a ser sometidos a un estudio con cápsula endoscópica
    E.1.1.1Medical condition in easily understood language
    We do not use these products in a concrete disease. We compare the effectiveness of these products to obtain an accurate bowel cleansing before performing a capsule endoscopic study.
    No los usamos en una enfermedad concreta. Nuestro objetivo es comparar su eficacia para obtener una adecuada limpieza intestinal en aquellos pacientes sometidos a un estudio con cápsula endoscópica
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the effectiveness of the preparation with PSMC versus the one usually used (PEG) to obtain a correct intestinal cleansing of patients undergoing capsule endoscopy study. The cleanliness level will be measured by a scale designed for this purpose.
    Evaluar la eficacia de la preparación intestinal con PSMC frente al habitual con PEG en función de la limpieza intestinal de los pacientes sometidos a estudio con CE. El nivel de limpieza se medirá siguiendo una escala diseñada a este fin.
    E.2.2Secondary objectives of the trial
    1 - Compare the bowel preparation tolerance between the experimental group (group taking PSMC) and control group (group taking PEG).
    2 - Compare adherence to the bowel cleansing protocol between the experimental group (group taking PSMC) and control group (group taking PEG).
    3 - Compare the percentage of adverse effects between the experimental group (group taking PSMC) and control group (group taking PEG).
    4 - To evaluate the reproducibility of the scale that we have designed to measure intestinal cleansing.
    1- Comparar la tolerancia a la preparación intestinal entre el grupo experimental (grupo que toma el PSMC) y el grupo control (grupo que toma PEG).
    2- Comparar la adhesión a la preparación intestinal entre el grupo experimental (grupo que toma el PSMC) y el grupo control (grupo que toma PEG).
    3- Comparar el porcentaje de aparición de efectos adversos entre el grupo experimental (grupo que toma el PSMC) y el grupo control (grupo que toma PEG).
    4- Evaluar la Reproductibilidad de la escala ideada para medir la limpieza intestinal.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1 - Patients of both sexes, aged above 18 years.
    2 - Have any symptom or condition for which is necessary to make a capsule endoscopy study.
    3 - Patients who after being informed of the study give written consent for the study.
    1- Pacientes de ambos sexos, mayores de 18 años.
    2- Que tengan algún síntoma o patología por el que se le ha indicado un estudio con cápsula endoscópica.
    3- Pacientes que tras ser informados del estudio otorguen consentimiento por escrito para la realización del estudio.
    E.4Principal exclusion criteria
    1 - Coexistence of severe organic disease that contraindicate making the intestinal cleansingor presenting any medical contraindications to drinking large volumes of fluid (I. Cardiac symptomatic IRenal with CrCl <50%).
    2 - contraindication or allergy to any component of the preparations (hypersensitivity to any of the ingredients of the products).
    3 - Any medical contraindications included in product sheet: severe dehydration, hypermagnesemia, gastric retention, gastrointestinal ulceration, toxic colitis, toxic megacolon, ileus, nausea and vomiting, ascites, acute surgical abdominal conditions such as appendicitis and obstruction or known or suspected gastrointestinal perforation., rhabdomyolysis as laxatives can induce this condition and may therefore exacerbate. No use in patients with active inflammatory bowel disease known, eg Crohn's disease, ulcerative colitis. Phenylketonuria. Glucose 6-phosphate dehydrogenase deficiency.
    3 - In patients with suspected suffering from a bowel obstruction or fistula.
    4 - Patients with cognitive impairment that makes it impossible to complete the questionnaires.
    5 - Coexisting psychiatric condition that impairs the patient to answer the the questionnaires properly.
    6 - Illiteracy and language problems that hinder the realization of the tests.
    7 - Pregnancy.
    8 - We exclude urgent capsule endoscopy explorations.
    1- Coexistencia de patología orgánica severa que impida o dificulte la toma de la preparación o aquellos que presenten alguna contraindicación médica a la ingesta de grandes volúmenes de líquido (I. Cardíaca sintomática, IRenal con ClCr<50%).
    2- Contraindicación médica o alergia a alguno de los componentes de las preparaciones (hipersensibilidad a cualquiera de los ingredientes de los productos).
    3- Presentar alguna Contraindicaciónes de la medicación de ficha técnica de los productos: deshidratación grave, hipermagnesemia, retención gástrica, ulceración gastrointestinal, colitis tóxica, megacolon tóxico, íleo, náuseas y vómitos, ascitis, procesos abdominales quirúrgicos agudos tales como apendicitis aguda y obstrucción o perforación gastrointestinal conocida o sospechada., rabdomiolisis ya que los laxantes pueden inducir esta afección y pueden por lo tanto exacerbarla. No usar en pacientes con enfermedad intestinal inflamatoria activa conocida, p.ej., enfermedad de Crohn, colitis ulcerosa. Fenilcetonuria. Déficit glucosa 6 fosfato deshidrogenasa.
    3- En pacientes en los que se sospecha, basándose en el cuadro clínico o en las pruebas y registros obtenidos antes del procedimiento, que padecen una obstrucción intestinal o fístulas.
    4- Pacientes con deterioro cognitivo que haga imposible cumplimentar los cuestionarios.
    5- Coexistencia de patología psiquiátrica que incapacite al paciente la contestación adecuada a los cuestionarios.
    6- Analfabetismo o Problemas idiomáticos que dificulten la realización de los tests.
    7- Embarazo.
    8- Excluiremos las exploraciones solicitadas con carácter urgente, ya que la rapidez con la que se debe realizar la prueba, impide la realización correcta de la dieta que se debe realizar los días previos a la realización de la prueba.
    E.5 End points
    E.5.1Primary end point(s)
    Our main hypothesis is that the proposed protocol, based on sodium picosulfate, light magnesium oxide, anhydrous citric acid (PSMC) is more effective than the current protocol, based on polyethylene glycol (PEG), to achieve adequate bowel cleansing in patients undergoing EC to study. Define the degree of bowel cleansing in patients using a scale designed ad hoc for this study.
    For this purpouse we will need to include 300 patients.
    Nuestra hipótesis principal es que el protocolo propuesto, basado en Picosulfato sódico, óxido de magnesio ligero, ácido cítrico anhidro (PSMC) es más eficaz que el protocolo actual, basado en polietilenglicol (PEG), para conseguir una adecuada limpieza intestinal en los pacientes sometidos a estudio con CE. Definiremos el grado de limpieza intestinal de los pacientes mediante una escala diseñada ad hoc en este estudio. Para ello necesitaremos la inclusión en el estudio de 300 pacientes
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 years
    3 años
    E.5.2Secondary end point(s)
    1- PSMC bowel preparation is better tolerated than PEG tolerance being measured by a test designed for this purpose.
    2- The degree of patient adherence to the intestinal preparation is greater when using the PSMC that when using PEG.
    3- PSMC bowel preparation has a lower percentage of adverse effects than with PEG.
    4- The scale we propose to assess bowel cleansing is reproducible for measuring the degree of cleanliness in studies with capsule endoscopy.
    H1 La preparación intestinal con PSMC es mejor tolerado que el PEG siendo la tolerancia medida según un test diseñado para este fin.
    H2 El grado de adherencia de los pacientes a la preparación intestinal es mayor cuando se utiliza el PSMC que cuando se utiliza PEG.
    H3 La preparación intestinal con PSMC presenta un menor porcentaje de efectos adversos Ej menos dolor abdominal, menos náuseas, menos vómitos, menos dolor de cabeza etc. que con el PEG.
    H4 La escala que proponemos para valorar la limpieza intestinal es reproducible para medir el grado de limpieza en los estudios con cápsula endoscópica.
    E.5.2.1Timepoint(s) of evaluation of this end point
    3 years
    3 años
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    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
    The last visit of the last subject will be considered the finsh of the study
    La última visita del último paciente marca el final de elstudio
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state300
    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)
    They will not nedd further treatment
    No necesitan otros tratamientos adicionales.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-07-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-06-06
    P. End of Trial
    P.End of Trial StatusOngoing
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