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    Summary
    EudraCT Number:2007-005312-62
    Sponsor's Protocol Code Number:F60038 GE 401
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2008-01-31
    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 number2007-005312-62
    A.3Full title of the trial
    Etude chez le sujet volontaire sain de l’effet de carbolevure versus placebo sur la fermentation intestinale induite par l’ingestion de lactulose.
    A.4.1Sponsor's protocol code numberF60038 GE 401
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorPierre Fabre Médicament
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Carbolevure
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratoires VEDIM 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 Capsule*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typeMineral : charcoal Probiotics : Yeast
    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
    Observation chez le sujet volontaire sain de la production d’hydrogène secondaire à l’administration de lactulose avec une administration concomitante de carbolevure, association de charbon activé et de levure déshydratée vivante, ou de placebo.

    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10065439
    E.1.2Term Hydrogen breath test
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    L'objectif principal de cet essai est d’évaluer l’effet de Carbolevure® sur la fermentation intestinale induite par l’ingestion de lactulose par la mesure du taux d’hydrogène expiré.
    E.2.2Secondary objectives of the trial
    Les objectifs secondaires sont d’évaluer:
    - l’effet de Carbolevureâ sur le ballonnement abdominal après ingestion de lactulose
    - l’effet de Carbolevureâ sur les douleurs abdominales après ingestion de lactulose
    - la tolérance de Carbolevure®
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    o Homme ou femme dont l’âge est compris entre 18 et 60 ans (bornes incluses),
    o Ayant un taux d’hydrogène expiré supérieur ou égal à 10 ppm sur au moins 3 mesures consécutives lors du test respiratoire réalisé à la sélection,
    o Affilié à un régime de sécurité sociale ou bénéficiant d’un tel régime,
    o Acceptant de participer à l’étude après avoir lu et compris le document écrit d’information et signé le formulaire de consentement,
    o Suffisamment coopérant pour se conformer aux impératifs de l'étude.
    E.4Principal exclusion criteria
    o Existence d’une affection sévère chronique cardio-vasculaire, rénale, hépatique, gastro-intestinale, endocrinienne, hématologique, neuro-psychiatrique, respiratoire ou allergique jugée par l'investigateur incompatible avec la réalisation de l'essai,
    o Existence d’anomalies caractérisées du transit intestinal (diarrhée définie par l’émission de 3 selles liquides ou pâteuses par jour ou constipation définie par un nombre de selles hebdomadaires inférieur à 3 et/ou des difficultés régulières d’évacuation du rectum),
    o Présence d’antécédent ou symptomatologie d’une pathologie gastro-intestinale,
    o Existence d’une allergie ou une intolérance connue à l'un des constituants du produit (charbon activé),
    o Existence d’une allergie ou une intolérance connue au lactulose,
    o Ayant un indice de masse corporelle inférieur ou égale à 19 kg/m² ou supérieur à 27 kg/m²,
    o Ayant un score d’anxiété ou un score de dépression supérieur à 11 sur l’échelle HAD,
    o Prise d’un traitement médicamenteux, notamment les antibiotiques, les laxatifs et tout autre traitement pouvant influencer la motricité intestinale pris dans le mois précédent le début de l’étude,
    o Etant dans la période d'exclusion dans le Fichier National des volontaires, participation à un autre essai clinique ou prévision de participer à un autre essai clinique dans les 30 jours suivant sa participation à la présente étude,
    o Perception d'un montant total d'indemnités supérieur à 4500 Euros sur les 12 derniers mois,
    o Possibilité, d'après l'investigateur, de manquer d'esprit de coopération pendant l'étude,
    o Incapacité linguistique ou psychique de signer le consentement éclairé,
    o Refus de donner son consentement par écrit,
    o Privation de liberté par décision administrative ou judiciaire, ou est sous tutelle ou curatelle,
    o Incapacité à être contacté par téléphone en cas d'urgence.

    Pour les femmes :
    o grossesse ou allaitement en cours,
    o absence de contraception efficace (contraceptifs oraux, dispositif intra-utérin, ligature des trompes).
    E.5 End points
    E.5.1Primary end point(s)
    Le critère principal d’évaluation est la mesure des taux d’hydrogène expirés avant et après administration de 10g de lactulose.
    Cinq tests respiratoires seront effectués pour chaque sujet avant et après administration de lactulose, au début et à la fin de chaque période de traitement (voir annexe 17.3):
    - Sélection, visite V1
    - période 1, visite V2 (J7 ± 3),
    - période 1, visite V3 (J14 ± 3),
    - période 2, visite V4 (J21 ± 3),
    - période 2, visite V5 (J28 ± 3).
    Les temps de mesure seront (en minutes) : -15, 0 (ingestion de lactulose), 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210, 225 et 240.

    Chaque sac à gaz hermétique utilisé lors des tests respiratoires sera identifié par :
    - le numéro de protocole,
    - le code sujet composé du numéro de centre, du numéro de patient, des initiales du sujet (3 premières lettres du nom et les 2 premières du prénom),
    - l’identification de la visite (V1, V2, V3, V4 ou V5),
    - la date de la visite,
    - le temps du recueil en minutes.
    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 No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    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.8.3 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 concerned2
    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 Information not present in EudraCT
    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 years0
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months4
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    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 Yes
    F.3.2Patients No
    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 state16
    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 Decision2008-03-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-03-03
    P. End of Trial
    P.End of Trial StatusOngoing
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