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    Summary
    EudraCT Number:2022-003817-12
    Sponsor's Protocol Code Number:2021/0384/HP
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2023-01-26
    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 number2022-003817-12
    A.3Full title of the trial
    Mechanisms of action on rectal motility of intrarectal botulinum toxin injections in patients with fecal incontinence
    Mécanismes d’action sur la motricité rectale des injections de toxine botulique intra-rectales chez les patients souffrant d’incontinence fécale
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Mechanisms of action on rectal motility of intrarectal botulinum toxin injections in patients with fecal incontinence
    Mécanismes d’action sur la motricité rectale des injections de toxine botulique intra-rectales chez les patients souffrant d’incontinence fécale
    A.4.1Sponsor's protocol code number2021/0384/HP
    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 Rouen
    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 Rouen
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU de Rouen
    B.5.2Functional name of contact pointDavid Mallet
    B.5.3 Address:
    B.5.3.1Street Address1 rue de Germont
    B.5.3.2Town/ cityRouen
    B.5.3.3Post code76031
    B.5.3.4CountryFrance
    B.5.4Telephone number+33232888265
    B.5.5Fax number+33232888287
    B.5.6E-mailsecretariat.DRC@chu-rouen.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 BOTOX 200 UNITÉS ALLERGAN, poudre pour solution injectable
    D.2.1.1.2Name of the Marketing Authorisation holderABBVIE
    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 nameBOTOX 200 UNITÉS ALLERGAN, poudre pour solution injectable
    D.3.4Pharmaceutical form Powder for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPRectal 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
    Patients with fecal incontinence who have failed conservative treatments and are candidates for intrarectal botulinum toxin injections.
    Patients souffrant d’incontinence fécale en échec des traitements conservateurs et candidats aux injections intra-rectales de toxine botulique.
    E.1.1.1Medical condition in easily understood language
    Patients with fecal incontinence
    Patients souffrant d’incontinence fécale
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10016296
    E.1.2Term Fecal incontinence
    E.1.2System Organ Class 100000004856
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To study, 1 month after intra-rectal injections, the effect of botulinum toxin on rectal motricity stimulated by laxative instillation and recorded in high resolution manometry.
    Étudier, 1 mois après la réalisation des injections intra-rectales, l’effet de la toxine botulique sur la motricité rectale stimulée par l’instillation de laxatifs et enregistrée en manométrie haute-résolution.
    E.2.2Secondary objectives of the trial
    - Evaluate the clinical efficacy of botulinum toxin injections at 1 month after injections.
    - Evaluate the quality of life at 1 month after the injections
    - Evaluate the tolerance of botulinum toxin injections
    - Évaluer l’efficacité clinique des injections de toxine botulique à 1 mois des injections.
    - Évaluer la qualité de vie à 1 mois des injections
    - Évaluer la tolérance des injections de toxine botulique
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Active or predominantly active fecal incontinence with failure of first-line conservative treatments (normalization of transit, perineal rehabilitation)
    - Impairment of quality of life left to the discretion of the investigator
    - Patients at least 18 years old
    - Patients who have read and understood the information letter and signed the consent form
    - Patients affiliated to the French Social Security system
    - Women of childbearing age with effective contraception (Cf. CTFG) (estrogen-progestin or intrauterine device or tubal ligation) and a negative urine pregnancy test by -HCG at inclusion, during the study period.
    - Postmenopausal woman: confirmatory diagnosis (non-medically induced amenorrhea for at least 12 months prior to the inclusion visit)
    - Men with a partner of childbearing age who must take contraception (Cf. CTFG) (estrogen-progestin or intrauterine device or tubal ligation) at inclusion, for the duration of the study.
    • Incontinence fécale active ou à prédominance active avec échec des traitements conservateurs de 1ère intention (normalisation du transit, rééducation périnéale)
    • Altération de la qualité de vie laissée selon l’appréciation de l’investigateur
    • Patients âgés d’au moins 18 ans
    • Patients ayant lu et compris la lettre d’information et signé le consentement
    • Patients affiliés au régime de la Sécurité Sociale
    • Femme en âge de procréer ayant une contraception efficace (Cf. CTFG) (oestro-progestatifs ou dispositif intra-utérin ou ligature de trompes) et un test de grossesse urinaire par -HCG négatif à l’inclusion, pendant la durée de l’étude.
    • Femme ménopausée : diagnostic de confirmation (aménorrhée non médicalement induite depuis au moins 12 mois avant la visite d’inclusion)
    • Homme avec une partenaire en âge procréer devant prendre une contraception (Cf. CTFG) (oestro-progestatifs ou dispositif intra-utérin ou ligature de trompes) à l’inclusion, pendant la durée de l’étude.
    E.4Principal exclusion criteria
    - Pregnant woman, parturient, breastfeeding woman, woman able to procreate who has not had effective contraception according to the WHO definition (oestro-progestin or intra-uterine device or tubal ligation) for at least 3 months
    - Patient deprived of liberty by an administrative or judicial decision or subject of legal age (under guardianship or curatorship)
    - Exclusive passive fecal incontinence
    - Person suffering from constipation (Rome IV criteria)
    -Person presenting an inflammatory or cancerous digestive pathology
    - History of rectal surgery
    - Person participating in another research protocol or having participated in another research protocol within 4 weeks prior to the inclusion visit
    - Patients unable to receive botulinum toxin injections
    - patients who cannot tolerate short colonoscopy or manometry recording
    - patients with contraindications to colonic purging
    - Femme enceinte, parturiente, allaitante, femme en mesure de procréer n’ayant pas de contraception efficace selon la définition de l’OMS (oestro-progestatifs ou dispositif intra-utérin ou ligature de trompes) depuis au moins 3 mois
    - Patient privé de liberté par une décision administrative ou judiciaire ou sujet majeur protégé (sous tutelle ou curatelle)
    - Incontinence fécale passive exclusive
    - Personne souffrant de constipation (critères de Rome IV)
    -Personne présentant une pathologie digestive inflammatoire ou cancéreuse évolutive
    - Antécédent de chirurgie rectale
    - Personne participant à un autre protocole de recherche ou ayant participé à un autre protocole de recherche dans les 4 semaines précédant la visite d’inclusion
    - patients ne pouvant recevoir les injections de toxine botulique
    - patients ne pouvant supporter la coloscopie courte ou l’enregistrement par manométrie
    - patients ayant des contres indications à la purge colique
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint was the time to onset of high amplitude propagative contractions (HAPC) after instillation of DULCOLAX® in the sigmoid and rectum, before and 1 month after intra-rectal botulinum toxin injections.
    Le critère de jugement principal est le délai d’apparition des contractions propagées de grande amplitude (= « high amplitude propagative contractions », HAPC) après instillation de DULCOLAX® au niveau du sigmoïde et du rectum, avant et 1 mois après injections intra-rectales de toxine botulique.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 month after BOTOX injection
    1 mois après les injections de BOTOX
    E.5.2Secondary end point(s)
    The secondary endpoints were:
    - The characteristics of the contractions at the level of the rectum and the sigmoid measured before then 1 month after injections of botulinum toxin: number, frequency, amplitude, duration of the HAPC, index of contractility, number and characteristics of the contractions (propagated or retropropagated).
    - Expulsion or not of the probe (which is an indirect sign of the efficiency of the colorectal motricity) as well as the delay of expulsion of the probe.
    - Severity scores (Cleveland Score, Appendix 2), stool schedule and quality of life score (FIQL Score, Appendix 4) before and 1 month after botulinum toxin injections.
    - Adverse events, which will be collected at each visit
    - Tolerance of the botulinum toxin treatment
    Les critères de jugement secondaires sont :
    - Les caractéristiques des contractions au niveau du rectum et du sigmoïde mesurés avant puis 1 mois après injections de toxine botulique : nombre, fréquence, amplitude, durée des HAPC, index de contractilité, nombre et caractéristiques des contractions (propagées ou retropropagées).
    - Expulsion ou non de la sonde (qui est un signe indirect d’efficacité de la motricité colo-rectale) ainsi que le délai d’expulsion de la sonde.
    - Les scores de sévérité (Score de Cleveland, Annexe 2), le calendrier des selles et le score de qualité de vie (Score FIQL, Annexe 4) avant et 1 mois après injections de toxine botulique.
    - Les évènements indésirables, qui seront recueillis à chaque visite
    - La tolérance du traitement par toxine botulique
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 month after botulinum toxin injections.
    1 mois après injections de toxine botulique.
    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 Yes
    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 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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    LVLS
    DVDP
    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 months4
    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 months4
    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: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 6
    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 state21
    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
    Aucun
    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 Decision2023-05-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-02-22
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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