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    The EU Clinical Trials Register currently displays   35891   clinical trials with a EudraCT protocol, of which   5892   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2014-000261-51
    Sponsor's Protocol Code Number:PHRC_IR_2013_BOMMELAER
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2015-08-28
    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 ConcernedFrance - ANSM
    A.2EudraCT number2014-000261-51
    A.3Full title of the trial
    POPCUR : a randomized, controlled, double bind study, comparing curcuma to placebo, associated with thiopurines, in the prevention of post-operative Crohn's disease recurrence
    Etude controllée, randomisée, en double aveugle, comparant la curcumine au placebo, associés aux thiopurines, dans la prévention de la récidive post-opératoire de la maladie de Crohn
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Randomized, controlled, double bind study, comparing curcumin to placebo, associated with thiopurines, in the the prevention of post-operative Crohn's desease relapse
    Etude controllée, randomisée, en double aveugle, comparant la curcumine au placebo, associés aux thiopurines, dans la prévention de la récidive post-opératoire de la maladie de Crohn
    A.3.2Name or abbreviated title of the trial where available
    POPCUR
    POPCUR
    A.4.1Sponsor's protocol code numberPHRC_IR_2013_BOMMELAER
    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 SponsorCHU de Clermont-Ferrand
    B.1.3.4CountryFrance
    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 supportCHU de Clermont-Ferrand
    B.4.2CountryFrance
    B.4.1Name of organisation providing supportGIRCI Rhône-Alpes Auvergne (ministère de la santé)
    B.4.2CountryFrance
    B.4.1Name of organisation providing support3i Nature
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU de Clermont-Ferrand
    B.5.2Functional name of contact pointClinical Research Departement
    B.5.3 Address:
    B.5.3.1Street Address58 rue Montalembert
    B.5.3.2Town/ cityClermont-Ferrand
    B.5.3.3Post code63000
    B.5.3.4CountryFrance
    B.5.4Telephone number+334737501195
    B.5.5Fax number+33473754730
    B.5.6E-mailplacarin@chu-clermontferrand.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 No
    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.3.1Product nameCurcuma
    D.3.4Pharmaceutical form Capsule
    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.3.9.1CAS number 8000051-72-1
    D.3.9.3Other descriptive nameCURCUMA LONGA RHIZOMA
    D.3.9.4EV Substance CodeSUB13507MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number95 to 100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    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 Yes
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Crohn's Disease
    Maladie de Crohn
    E.1.1.1Medical condition in easily understood language
    Crohn's Disease
    Maladie de Crohn
    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 18.0
    E.1.2Level PT
    E.1.2Classification code 10011401
    E.1.2Term Crohn's disease
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Comparer l’efficacité de curcumine + azathioprine versus placebo + azathioprine dans la prévention de la récidive postopératoire de la maladie de Crohn évaluée par le score endoscopique de Rutgeerts à 6 mois.
    E.2.2Secondary objectives of the trial
    1. Comparer l’efficacité de curcumine + azathioprine versus placebo + azathioprine dans la prévention de la récidive clinique postopératoire à 6 mois et 1 an
    2. Etudier la relation entre les marqueurs d’inflammation (CRP, calprotectine fécale), leur évolution et le score endoscopique à 6 mois
    3. Etudier la relation entre l’évaluation lésionnelle par IRM et le score endoscopique à 6 mois
    4. Etudier la relation entre les marqueurs d’inflammation (CRP, calprotectine fécale), leur évolution et la récidive clinique à 6 mois et 1 an
    5. Etudier le taux de récidive en fonction du nombre et du type de facteurs de risque de récidive (tabagisme, maladie perforante, antécédent de résection, résection > 0,5 mètre et localisation ano-périnéale)
    6. Comparer les délais jusqu’à récidive clinique entre groupes de randomisation
    7. Comparer le taux de récidive chirurgicale entre les 2 groupes 8. Evaluer la tolérance au de la curcumine
    9. Evaluer l’impact de la curcumine sur la qualité de vie
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Malades atteints d’une maladie de Crohn confirmée par examen radiologique, endoscopique ou histologique
    • Age > 18ans
    • Patients bénéficiant du régime de l’assurance maladie
    • Attestant comprendre la note d’information et désirant participer à l’étude
    • Opérés ou remis en continuité depuis moins de 15 jours, d’une maladie de Crohn, iléale ou iléo-colique.
    • Dont toutes les lésions radiologiquement, endoscopiquement ou cliniquement décelables ont été enlevées
    • Porteur d’une anastomose atteignable par iléo-coloscopie
    E.4Principal exclusion criteria
    • RCH, colite indéterminée
    • Femme enceinte ou allaitante
    • Femme en âge de procréer refusant l’utilisation d’un moyen de contraception efficace
    • Indication de traitement par anti-TNF
    • Traitements en cours par antibiotiques, probiotiques, mesalazine, méthotrexate, ciclosporine, tacrolimus, anti-TNF, ustekinumab.
    • Traitement en cours par corticoïdes, sauf dans le cadre d’une décroissance d’un traitement initié avant l’intervention chirurgicale
    • Insuffisance rénale chronique (créatinine > 2X valeur normale du laboratoire)
    • Hépathopathie chronique hormis cholangite sclérosante primitive
    • Transaminases, phosphatases alcalines, ou bilirubine supérieures à 3 fois la normale
    • Infection par HIV, HBV (sauf si anticorps anti-HBs positifs), HCV avec des sérologies datant de moins de 3 mois.
    • Contre-indications à l’Imurel : fièvre jaune, hypersensibilité connue à l’Imurel, prise d’allopurinol
    • Sujet non compliant
    E.5 End points
    E.5.1Primary end point(s)
    Le critère d’évaluation principal sera la proportion de patients dans chaque bras avec un score endoscopique de Rutgeerts > i2 à l’iléo-coloscopie pratiquée à 6 mois de la chirurgie avec rétablissement de la continuité.
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 mois
    E.5.2Secondary end point(s)
    • Distribution des malades selon les 5 classes du score endoscopique de Rutgeerts à 6 mois.
    • Taux de récidive postopératoire endoscopique sévère (Rutgeerts > i3)
    • Taux de récidive postopératoire clinique à 6 mois et un an, définie par CDAI > 150 Cf.
    • Délai, en semaines, avant récidive postopératoire clinique, définie par CDAI > 150
    • Taux sérique de la CRP à chaque visite (inclusion, 1 mois, 3 mois, 6 mois, 1 an)
    • Résultats IRM
    • Type et nombre de facteurs de risque RPO (tabagisme, maladie perforante, antécédent de résection, résection > 0,5 mètre et localisation ano-périnéale)
    • Taux de récidive postopératoire chirurgicale à 1 an
    • Mesure de la calprotectine fécale à chaque visite (inclusion, 1 mois, 3 mois, 6 mois et un an)
    • Effets indésirables liés à la tolérance de la curcumine
    • Qualité de vie mesurée par IBD-Q entre J0, V6 et V12 (
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 monh
    3 months
    6 months
    1 year
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy No
    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) 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 No
    E.8.1.4Double blind Yes
    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) No
    E.8.2.2Placebo Yes
    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 concerned7
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    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: 90
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state122
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 122
    F.4.2.2In the whole clinical trial 122
    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)
    N/A
    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 Decision2014-09-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-11-04
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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