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    Summary
    EudraCT Number:2016-002265-60
    Sponsor's Protocol Code Number:F-FR-58800-003
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-01-19
    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
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2016-002265-60
    A.3Full title of the trial
    EFFICACY, SAFETY AND TOLERABILITY OF A BOWEL CLEANSING PREPARATION (EZICLEN®/IZINOVA®) IN PAEDIATRIC SUBJECTS UNDERGOING COLONOSCOPY: A PHASE III, MULTICENTRE, RANDOMISED, COMPARATIVE STUDY VERSUS KLEAN-PREP® (PEG-ELECTROLYTES), ADMINISTERED ON THE DAY BEFORE COLONOSCOPY, INVESTIGATOR-BLINDED, NON-INFERIORITY IN ADOLESCENTS OF 12 TO 17 YEARS OF AGE (INCLUSIVE) ≥40 KG.

    P/214/2011
    Etude de Phase III, multicentrique, randomisée, de non infériorité, en simple aveugle, évaluant l’efficacité, la sécurité et la tolérance d’une préparation de lavage colique : l’Eziclen®/Izinova® par comparaison au Klean-Prep® (Electrolytes PEG), administrés la veille de la coloscopie chez des adolescents âgés de 12 à 17 ans inclus et pesant ≥ 40 kg.

    P/214/2011
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    COMPARAISON OF THE EFFICACY, SAFETY AND TOLERABILITY OF EZICLEN®/IZINOVA® VERSUS KLEAN-PREP® ON BOWEL CLEANSING IN ADOLESCENTS AGED 12-17 YEARS ≥40 KG UNDERGOING COLONOSCOPY.
    Comparaison de l’efficacité, la sécurité et la tolérance de l’Eziclen®/Izinova® et du Klean-Prep® sur le lavage colique avant coloscopie chez des adolescents âgés de 12 à 17 ans inclus et pesant ≥ 40 kg.
    A.3.2Name or abbreviated title of the trial where available
    EASYKID
    A.4.1Sponsor's protocol code numberF-FR-58800-003
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/169/2016
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorIpsen Pharma
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportIpsen Pharma
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationICTA PM
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street Address11 rue du Bocage
    B.5.3.2Town/ cityFONTAINE-LES-DIJON
    B.5.3.3Post code21121
    B.5.3.4CountryFrance
    B.5.4Telephone number33380534059
    B.5.5Fax number33380571022
    B.5.6E-maileasykid@icta.fr
    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 Izinova
    D.2.1.1.2Name of the Marketing Authorisation holderIPSEN PHARMA
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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.3.4Pharmaceutical form Concentrate for oral solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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 Klean-Prep
    D.2.1.1.2Name of the Marketing Authorisation holderNORGINE
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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.3.4Pharmaceutical form Powder for oral solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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
    Routinely accepted indication for undergoing colonoscopy, including but not limited to polyposis coli diagnosis or surveillance, gastrointestinal bleeding, unexplained diarrhoea or constipation, surveillance of inflammatory bowel disease or confirmation of mucosal healing, abdominal pain, abnormal endosonography or manometry, anaemia of unknown aetiology, cancer surveillance
    Indication acceptée en routine pour réaliser une coloscopie, incluant mais non limitée au diagnostic ou à la surveillance de polyposies coli, saignement gastro-intestinal, diarrhée ou constipation inexpliquées, surveillance des maladies intestinales inflammatoires ou confirmation de cicatrisation mucosale, douleur abdominale, endosonographie ou manométrie anormales, anémie sans étiologie connue, surveillance de cancer
    E.1.1.1Medical condition in easily understood language
    Children who have been prescribed a colonoscopy.
    Enfants ayant une prescription de coloscopie.
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level PT
    E.1.2Classification code 10010007
    E.1.2Term Colonoscopy
    E.1.2System Organ Class 10022891 - Investigations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to demonstrate that Eziclen®/Izinova®, an osmotic sulphate-based laxative preparation given on the day before colonoscopy has non-inferior efficacy to Klean-Prep® (polyethylene glycol (PEG)-electrolytes) on colon cleansing in adolescents aged 12 to 17 years (inclusive) with a body weight ≥40 kg, scheduled to undergo a colonoscopy for a routinely accepted diagnostic indication.
    L'objectif principal est de démontrer que Eziclen®/Izinova®, une préparation laxative osmotique à base de sulfate délivrée la veille de la coloscopie a une efficacité non-inférieure à celle de Klean-Prep® (polyéthylène glycol (PEG)-électrolytes) pour le lavage colique chez l’adolescent âgé de 12 à 17 ans (inclus) et pesant ≥40 kg, devant réalisé une coloscopie pour établir un diagnostic de pratique courante.
    E.2.2Secondary objectives of the trial
    The secondary objectives are:
    - To compare efficacy of Eziclen®/Izinova® versus Klean-Prep® on overall and segmental cleansing and colonoscopy quality indicators
    - To assess compliance with preparation administration in both study arms
    - To compare safety, acceptability and tolerability of Eziclen®/Izinova®versus Klean- Prep®
    Les objectifs secondaires sont de:
    - Comparer l’efficacité de l’Eziclen®/Izinova® versus Klean-Prep® sur le lavage
    global et par segments et sur les indicateurs de qualité de la coloscopie
    - Evaluer l’observance de la prise du traitement dans les deux groupes de l’étude
    - Comparer la sécurité, l’acceptabilité et la tolérance d’Eziclen®/Izinova® à celles de
    Klean-Prep®
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subject MUST satisfy all of the following entry criteria before being allowed to participate in the study:
    (1) Provision of signed informed consent form (ICF) to participate in the study obtained from the adolescent's parent(s)/ legal representative and a signed assent form from the adolescent according to local law
    (2) Male or female subjects between 12 to 17 years of age (inclusive)
    (3) Body weight more than or equal to 40 kg
    (4) Female of childbearing potential must have a negative pregnancy test
    (5) If female, and of child-bearing potential, subject must use an acceptable form of birth control (hormonal birth control, intrauterine device (IUD), double-barrier method, or depot contraceptive)
    (6) Routinely accepted indication for undergoing colonoscopy, including but not limited to polyposis coli diagnosis or surveillance, gastrointestinal bleeding, unexplained diarrhoea or constipation, surveillance of inflammatory bowel disease or confirmation of mucosal healing, abdominal pain, abnormal endosonography or manometry, anaemia of unknown aetiology, cancer surveillance
    (7) In the investigator’s judgment, the parent(s)/legal representative are/is mentally competent to provide informed consent for the subject to participate in the study
    (8) In the investigator’s judgement, subject is able and willing to follow study procedures including drug administration and response to questionnaires
    Le sujet DOIT satisfaire aux critères d’inclusions suivants avant d’être autorisé à participer à cette étude :
    (1) Obtention du consentement éclairé signé (CE) par le(s) parent(s)/ représentant légal et de l’assentiment signé par l’adolescent conformément à la loi en vigueur, afin de participer à l’étude
    (2) Sujets de sexe masculin ou féminin âgés entre 12 et 17 ans (inclus)
    (3) Poids supérieur ou égal à 40 kg
    (4) Les filles en âge de procréer doivent avoir un test de grossesse négatif
    (5) Les filles en âge de procréer doivent utiliser une méthode contraceptive efficace (contrôle hormonal, dispositif intra-utérin, méthode avec double barrière, ou contraception dite depot)
    (6) Indication acceptée en routine pour réaliser une coloscopie, incluant mais non limitée au diagnostic ou à la surveillance de polyposies coli, saignement gastro-intestinal, diarrhée ou constipation inexpliquées, surveillance des maladies intestinales inflammatoires ou confirmation de cicatrisation mucosale, douleur abdominale, endosonographie ou manométrie anormales, anémie sans étiologie connue, surveillance de cancer
    (7) Selon le jugement de l’investigateur, le(s) parent(s)/représentant légal est/sont mentalement apte à fournir un consentement éclairé pour le sujet afin de participer à l’étude
    (8) Selon le jugement de l’investigateur, le sujet est apte et volontaire pour suivre les procédures de l’étude incluant l’administration du médicament et la réponse aux questionnaires
    E.4Principal exclusion criteria
    If any of the following apply, the subject MUST NOT enter/continue in the study:
    (1) Subject with known or suspected ileus, gastrointestinal obstruction, gastric retention (gastroparesis), rectal impaction, toxic colitis, severe ulcerative colitis or toxic megacolon, swallowing disorders
    (2) Subject with known or suspected inflammatory bowel disease (Crohn’s disease, ulcerative colitis) in moderate to severe active phase defined by PCDAI >30 (Crohn’s disease) or PUCAI >34 (ulcerative colitis)
    (3) Subject with bowel perforation or increased risk of bowel perforation, including connective tissue disorders or recent bowel surgery
    (4) Subject with previous significant gastrointestinal surgery (e.g. colostomy, colectomy, gastric bypass, stomach stapling)
    (5) Subject with uncontrolled pre-existing electrolyte abnormalities, or with electrolyte abnormalities based on Visit 1 laboratory results such as hypernatremia, hyponatremia, hyperphosphatemia, hypokalaemia, hypocalcaemia, uncorrected dehydration, or secondary to the use of diuretics or angiotensin converting enzyme (ACE) inhibitors judged clinically significant by the investigator
    (6) Subject with a prior history or current condition of severe renal (estimated glomerular filtration rate (GFR) less than 30 mL/min/1.73 m2), liver (Child-Pugh C) or cardiac insufficiency (including congestive heart failure grade III and IV)
    (7) Female subject who is pregnant or lactating
    (8) Subject who has participated in another investigational drug treatment within the last 90 days before the first study visit
    (9) Subject with phenylketonuria
    (10) Subject with history of hypersensitivity to any ingredient of either drug product
    (11) Subject for whom intake of substances likely to affect gastrointestinal motility or urinary flow rate is required
    (12) Subject with requirement to take any other oral medication within 3 hours of starting the bowel preparation, as this may impact medication absorption
    (13) Subject with tendency for nausea and/or vomiting
    (14) Subject with impaired consciousness that predisposes them to pulmonary aspiration or who have known swallowing disorders
    (15) Subject with history of major medical/psychiatric conditions that, in the judgment of the investigator, would compromise safety in the study
    (16) Subject with mental or psychiatric condition rendering the subject unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude
    (17) Subject with a condition that, in the opinion of the investigator, might increase the risk to the subject or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study
    (18) Subject who has previous enrolment in this study or concomitant enrolment in other clinical studies
    Si l’un des critères suivant s’applique, le sujet NE DOIT PAS entrer dans/continuer l’étude:
    (1) Sujet avec iléus connu ou suspecté, obstruction gastro-intestinale, rétention gastrique (gastro parésie), impaction fécale, colite toxique, colite ulcérative sévère ou mégacôlon toxique, troubles de la déglutition
    (2) Sujet présentant une maladie intestinale inflammatoire connue ou suspectée (maladie de Crohn, colite ulcérative) en phase active modérée à sévère définie par : PCDAI >30 (maladie de Crohn) ou PUCAI >34 (colite ulcérative)
    (3) Sujet ayant une perforation intestinale ou un risque accru de perforation intestinale, incluant des troubles du tissu conjonctif ou une chirurgie intestinale récente
    (4) Sujet avec antécédent significatif de chirurgie gastro-intestinale (e.g. colostomie, colectomie, dérivation gastrique, gastroplastie)
    (5) Sujet présentant des anomalies électrolytiques préexistantes non contrôlées, ou mises en évidence à partir des résultats biologiques de la Visite 1 et jugées cliniquement significatives par l’investigateur comme l’hypernatrémie, hyponatrémie, hyperphosphatémie, hypokaliémie, hypocalcémie, déshydratation non corrigée, ou secondaire à l’utilisation de diurétiques ou d’inhibiteurs de l’enzyme de conversion de l’angiotensine (ECA)
    (6) Sujet ayant, ou avec antécédent de, insuffisance rénale sévère (débit de filtration glomérulaire estimé (DFG) inférieur à 30 mL/min/1.73 m2), hépatique (Child-Pugh C) ou cardiaque (incluant insuffisance cardiaque congestive de grade III et IV)
    (7) Femme enceinte ou allaitante
    (8) Sujet ayant participé à une autre étude clinique dans les 90 jours précédant la première visite de l’étude
    (9) Sujet avec antécédent de phénylcétonurie
    (10) Sujet avec antécédent d’hypersensibilité à l’un des ingrédients de chaque produit à l’étude
    (11) Sujet pour lequel la prise de substance pouvant affecter la motilité gastro-intestinale ou le débit urinaire est exigée
    (12) Sujet devant prendre un autre médicament par voie orale dans les 3 heures précédant le lavage colique, car cela peut impacter l’absorption du médicament
    (13) Sujet ayant une propension à la nausée et/ou au vomissement
    (14) Sujet atteint de troubles de la conscience le prédisposant à l’aspiration pulmonaire ou ayant un trouble de déglutition connu
    (15) Sujet avec antécédent de conditions médicales/psychiatriques majeures qui, selon le jugement de l’investigateur, pourrait compromettre sa sécurité lors de l’étude
    (16) Sujet ayant une condition mentale ou psychiatrique le rendant inapte à comprendre la nature, la portée et les conséquences possibles de l'étude, et/ou ayant fait preuve d’une attitude non coopérative
    (17) Sujet ayant une condition qui, d'après le jugement de l’investigateur, pourrait augmenter les risques pour le sujet ou diminuer la chance d'obtenir des données satisfaisantes pour atteindre les objectifs de l’étude
    (18) Sujet ayant participé précédemment à cette étude ou en cours de participation à une autre étude clinique
    E.5 End points
    E.5.1Primary end point(s)
    Primary Endpoints and Evaluations:
    Non-inferiority of Eziclen®/Izinova®versus Klean-Prep® in the cleansing of the colon:
    Blinded overall assessment of preparation efficacy (Cleansing Score) as determined by the
    colonoscopist upon completion of the examination, based on a 4-point scale:
    Score // Grade // Description
    4 // Excellent // No more than small bits of adherent faeces/fluid
    3 // Good // Small amounts of faeces or fluid not interfering with examination
    2 // Fair // Enough faeces or fluid to prevent a completely reliable examination
    1 // Poor // Large amounts of faecal residue, additional cleansing required

    Only perfect preparations graded as excellent (4) or good (3), which allow full, reliable examination of the mucosa, will be considered as successful.
    Primary efficacy will be assessed on the basis of preparation success or failure.
    Critères de jugement primaires et évaluations :
    Non-infériorité d’Eziclen®/Izinova® versus Klean-Prep® dans le lavage colique :
    Evaluation générale en aveugle de l’efficacité de la préparation (score de lavage) déterminé par l'endoscopiste suite à la réalisation de l’examen, basée sur une échelle à 4 points :

    Score // Grade // Description
    4 // Excellent // Pas plus que de petits morceaux de matière fécale adhérente/fluide
    3 // Bon // Petites quantités de matière fécale ou fluide n’interférant pas avec l’examen
    2 // Faible // Suffisamment de matière fécale ou fluide pour empêcher un examen complètement fiable
    1 // Mauvais // Grande quantité de résidus de matière fécale, lavage additionnel requis

    Seules les préparations parfaites gradées comme excellent (4) ou bon (3), qui ont permis un examen complet et fiable de la muqueuse, seront considérées comme des succès.
    L'efficacité principale sera évaluée sur la base du succès ou de l'échec de la préparation.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary end point will be assessed at Visit 2 (colonoscopy).
    Le critère de jugement primaire sera évalué à la Visite 2 (coloscopie).
    E.5.2Secondary end point(s)
    Secondary Endpoints and Evaluations:
    - Need to place a nasogastric tube to complete preparation
    - Time to clear effluent (from first intake of preparation), as reported by the subject
    - Need for rescue treatment (saline enema) because of inadequate preparation
    - Cleansing Scores assessed by the 4-point scale (poor, fair, good, excellent)
    - Overall and segmental Cleansing Scores assessed by Boston Bowel Preparation Scale
    (BBPS)
    - Duration of intubation (from colonoscope introduction to caecal intubation)
    - Duration of examination, measured by colonoscope withdrawal time from caecum
    - Procedure documented as completed (procedures that reached the caecum)
    - Treatment compliance: volumes of fluids measured by the caregiver and reported in
    the treatment questionnaire of subject’s leaflet during treatment administration
    - Treatment acceptability, assessed by Treatment Acceptability Questionnaire completed by caregiver or subject at the time of intake using a 5-point scale questionnaire to be filled in by the subject immediately after dosing

    Very badly accepted/unacceptable // Subject showed great displeasure, compromising use of formulation
    Badly but accepted // Subject showed displeasure with dosing but could be coaxed to take complete dose
    Neither good nor bad // Subject showed no apparent displeasure and with little effort was coaxed to take complete dose
    Well accepted // Subject appeared to enjoy the formulation and with little coaxing ingested complete dose
    Very well accepted // Subject appeared eager and ingested complete without special coaxing

    Safety and tolerability:
    - Collection of adverse events (AEs) (for up to 30 days following the day of
    colonoscopy)
    - Tolerability by a Symptom Scale after each dose of treatment. Subjects will rate their
    preparation related symptoms after intake (stomach cramping, stomach bloating and
    nausea) on a paediatric 5-point scale, ranging from 1=no symptoms to 5= severely
    distressing symptoms
    - Description and histological examination of any colonic biopsy specimens of
    mucosal lesions suspected by the investigator to have been caused by colonic lavage
    - Vital signs including body weight and physical examination
    - Laboratory data: serum and urinary biochemistry (Visit 1, Visit 2, Visit 4)
    Critères de jugement secondaires et évaluations :
    - Nécessité de placer une sonde nasogastrique pour terminer la préparation
    - Le temps pour obtenir des selles claires (à partir de la première prise de la préparation), comme reporté par le sujet
    - Recours au traitement de secours (lavage par solution saline) à cause d’une mauvaise préparation
    - Score de lavage évalué par l’échelle à 4 points (excellent, bon, faible, mauvais)
    - Le score de lavage général et segmentaire basé sur le score BBPS : « Boston Bowel
    Preparation Scale »
    - La durée de l’intubation (depuis l’introduction du coloscope jusqu’à l’intubation caecale)
    - La durée de l’examen, mesurée au moment du retrait du coloscope du caecum
    - Procédure documentée comme complète (la procédure a atteint le caecum)
    - L'observance au traitement : les volumes de liquides mesurés par la personne donnant les soins et reportés dans le questionnaire de traitement du patient pendant son administration
    - L’acceptabilité du traitement, évaluée par le questionnaire d’acceptabilité du traitement complété par la personne donnant les soins ou le sujet lui-même immédiatement après la prise, sur une échelle à 5 points

    Très mal accepté / pas accepté // Le sujet a montré un grand mécontentement, mettant en péril l'utilisation de la préparation
    Mal mais accepté // Le sujet a montré un mécontentement pour la quantité utilisée mais pourrait être incité à prendre la dose complète
    Ni bien ni mal // Le sujet n’a pas montré un mécontentement apparent et avec peu d’effort a été incité à prendre la dose complète
    Bien accepté // Le sujet a apprécié la formulation et a ingéré la dose complète avec peu d’insistance
    Très bien accepté // Le sujet était désireux de terminer la dose et a pris la dose complète sans insistance

    Sécurité et tolérance :
    - La collecte les effets indésirables (EIs) (jusqu’à 30 jours après la coloscopie)
    - La tolérance évaluée par une Échelle de Symptômes après chaque dose de traitement. Les sujets noteront leurs symptômes relatifs à la prise du traitement (crampe d'estomac, ballonnement et nausée) sur une échelle pédiatrique à 5 points, allant de 1= pas de symptôme à 5 = symptômes extrêmement désagréables
    - La description et l’examen histologique de toute biopsie de lésions de la muqueuse du côlon soupçonnées par l’investigateur d’avoir été causé par le lavage colique
    - Les signes vitaux incluant le poids et l’examen physique
    - Les données biologiques : analyses biochimiques sériques et urinaires (Visite 1, Visite 2, Visite 4)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary end points will be assessed at Visits 1, 2, 3 and 4.
    Les critères de jugement secondaires seront évalués aux Visites 1, 2, 3 et 4.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    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 Yes
    E.6.13.1Other scope of the trial description
    Tolerabilty
    Tolérance
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    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 Yes
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA26
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 250
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 250
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 250
    F.4.2.2In the whole clinical trial 250
    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
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-01-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-01-10
    P. End of Trial
    P.End of Trial StatusCompleted
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