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    Summary
    EudraCT Number:2021-000593-29
    Sponsor's Protocol Code Number:CHUBX2020/64
    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:2021-03-03
    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 number2021-000593-29
    A.3Full title of the trial
    A Prospective Pilot Study to assess the efficacy of BOTOX-A in patients with Low Anterior Resection syndrome (LARS>20) and refractory medical treatment after rectal resection
    Etude pilote prospective pour évaluer l'efficacité du BOTOX-A chez les patients atteints du syndrome de résection antérieure (LARS> 20) après résection rectale et réfractaire au traitement médical
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Prospective Pilot Study to assess the efficacy of BOTOX-A in patients with Low Anterior Resection syndrome (LARS>20) and refractory medical treatment after rectal resection
    Etude pilote prospective pour évaluer l'efficacité du BOTOX-A chez les patients atteints du syndrome de résection antérieure (LARS> 20) après résection rectale et réfractaire au traitement médical
    A.3.2Name or abbreviated title of the trial where available
    BOTOX-TME
    BOTOX-TME
    A.4.1Sponsor's protocol code numberCHUBX2020/64
    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 BORDEAUX
    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 supportMinistère de la Santé
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU DE BORDEAUX
    B.5.2Functional name of contact pointSophie TABUTEAU
    B.5.3 Address:
    B.5.3.1Street Address12 rue Dubernat
    B.5.3.2Town/ cityTalence
    B.5.3.3Post code33404
    B.5.3.4CountryFrance
    B.5.4Telephone number33557821066
    B.5.5Fax number33556794926
    B.5.6E-mailsophie.tabuteau@chu-bordeaux.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 UNITES ALLERGAN
    D.2.1.1.2Name of the Marketing Authorisation holderALLERGAN FRANCE
    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 solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPAuricular use
    Rectal 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
    Low Anterior Resection syndrome (LARS>20) and refractory medical treatment after rectal resection
    Syndrome de résection antérieure (LARS> 20) après résection rectale et réfractaire au traitement médical
    E.1.1.1Medical condition in easily understood language
    Low Anterior Resection syndrome (LARS>20) and refractory medical treatment after rectal resection
    Syndrome de résection antérieure (LARS> 20) après résection rectale et réfractaire au traitement médical
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    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 assess the efficacy of BOTOX-A on the proportion of patients with bowel dysfunction (LARS score > 20) at 3 months after injection
    Évaluer l'efficacité du BOTOX-A sur la proportion de patients présentant une dysfonction intestinale (score LARS> 20) 3 mois après l'injection
    E.2.2Secondary objectives of the trial
    To evaluate
    - Compliance and Tolerance to treatment at 3 months
    - Functional outcome (LARS) at 0,1, 2, 3 and 6 months after injection
    - Faecal incontinence (WEXNER) at 0,1, 2, 3 and 6 months
    - Quality of life (QLQ-C30 and QLQ-CR29) at 0, 1, 3 and 6 months
    - Trait anxiety (STAI-Y trait) at baseline
    - State anxiety (STAI-Y state) at baseline, 1,3 and 6 months
    - Anorectal Ultrasound at baseline
    - Manometry at 0,1,3 and 6 months
    - Rectal compliance (Barostat) at 0,1,3 and 6 months
    - Efficacy of BOTOX-A at 6 months
    - Correlation between LARS and physiologic tests will be analyzed at 0, 1, 3 and 6 months
    Evaluer :
    - Compliance et tolérance au traitement à 3 mois
    - Résultat fonctionnel (LARS) à 0, 1, 2, 3 et 6 mois après l'injection
    - Incontinence fécale (WEXNER) à 0, 1, 2, 3 et 6 mois
    - Qualité de vie (QLQ-C30 et QLQ-CR29) à 0, 1, 3 et 6 mois
    - Trait d'anxiété (STAI-Y trait) à l’inclusion
    - Etat d’anxiété (STAI-Y état) à 0, 1, 3 et 6 mois
    - Echographie endo-anale à l’inclusion
    - Manométrie rectale à 0, 1, 3 et 6 mois
    - Plasticité rectale (Barostat) à 0, 1, 3 et 6 mois
    - Efficacité du BOTOX-A à 6 mois
    - Corrélation entre le LARS et les tests physiologiques sera analysée à 0, 1, 3 et 6 mois
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patient: male and female, age ≥18 years
    - Tumour: rectal cancer
    - Surgery: anterior resection (high or low) with colorectal or coloanal anastomosis, or intersphincteric resection, or pull-through
    - Symptoms: Low Anterior Resection Syndrome (LARS score >20) refractory to medical treatment at 3 months after rectal surgery (or after temporary stoma closed)
    - Straight or pouch colonic reconstruction
    - Surgery alone or with neoadjuvant therapy (chemoradiotherapy, short course radiotherapy, induction chemotherapy)
    - Signed and dated informed consent
    - Patient affiliated to a social security system or beneficiary of the same Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
    - Patient: homme et femme, âge ≥ 18 ans
    - Patients opéré d’un cancer rectal
    - Chirurgie: résection antérieure (haute ou basse) avec anastomose colorectale ou coloanale, ou résection intersphinctérique, ou pull-through
    - Symptômes: Syndrome de résection antérieure basse (score LARS> 20) réfractaire au traitement médical à 3 mois après chirurgie rectale (ou après fermeture temporaire de la stomie)
    - Reconstruction colique droite ou en poche
    - Chirurgie seule ou avec thérapie néoadjuvante (chimioradiothérapie, radiothérapie de courte durée, chimiothérapie d'induction)
    - Consentement éclairé signé et daté
    - Patient affilié à un système de sécurité sociale ou bénéficiaire de la même volonté et capacité à se conformer aux visites programmées, aux plans de traitement, aux tests de laboratoire et aux autres procédures d'étude
    E.4Principal exclusion criteria
    - Anal cancer
    - Anal surgery in the last 3 months
    - Acute/painful perianal disease
    - Without adjuvant treatment
    - Contraindication for BOTOX-A (known hypersensitivity to botulinum toxin type A or to albumin, infection at the proposed injection site, severe myastenia)
    - Have received BOTOX-A in perianal region in the previous 3 months
    - General anesthesia performed less than a month
    - Impossibility of performing a rectoscopy (eg: anal stenosis)
    - Recent history (<12 months) of myocardial infarction and / or arrhythmias not reduced by appropriate treatment
    - Subject with a significant deficit of clinical or subclinical neuromuscular transmission (myasthenia or Lambert-Eaton syndrome) or with peripheral motor neuropathy (such as amyotrophic lateral sclerosis or motor neuropathy)
    - Treatment that directly or indirectly interferes with neuromuscular transmission (aminoglycosides, curare, anticholinesterase, aminoquinoline, cyclosporine, etc.)
    - History of neuromuscular disorders
    - Anal clinical examination suggesting the presence of an anorectal abscess
    - Pregnant woman or breastfeeding woman
    - Women of child-bearing potential not using effective contraception (oestrogen-progesteron combined contraceptives or intra uterine device) since at least 7 days and during all the duration of the study
    - Persons deprived of their liberty or under measure of judicial protection (curatorship or guardianship) or unable to give their consent
    - Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol or follow-up schedule, as assessed by investigator
    - Cancer anal
    - Chirurgie anale au cours des 3 derniers mois
    - Maladie périanale aiguë / douloureuse
    - Sans traitement adjuvant
    - Contre-indication au BOTOX-A (hypersensibilité connue à la toxine botulique de type A ou à l'albumine, infection au site d'injection proposé, myasténie sévère)
    - Avoir reçu du BOTOX-A dans la région périanale au cours des 3 mois précédents
    - Anesthésie générale réalisée moins d'un mois
    - Impossibilité d'effectuer une rectoscopie (ex: sténose anale)
    - Antécédents récents (<12 mois) d'infarctus du myocarde et / ou d'arythmies non réduits par un traitement approprié
    - Sujet avec un déficit important de transmission neuromusculaire clinique ou subclinique (myasthénie ou syndrome de Lambert-Eaton) ou avec une neuropathie motrice périphérique (telle que sclérose latérale amyotrophique ou neuropathie motrice)
    - Traitement qui interfère directement ou indirectement avec la transmission neuromusculaire (aminosides, curare, anticholinestérase, aminoquinoléine, cyclosporine, etc.)
    - Antécédents de troubles neuromusculaires
    - Examen clinique anal suggérant la présence d'un abcès ano-rectal
    - Femme enceinte ou femme qui allaite
    - Femmes en âge de procréer n'utilisant pas de contraception efficace (contraceptifs combinés oestro-progestérone ou dispositif intra-utérin) depuis au moins 7 jours et pendant toute la durée de l'étude
    - Personnes privées de liberté ou sous mesure de protection judiciaire (curatelle ou tutelle) ou incapables de donner leur consentement
    - Toute condition psychologique, familiale, sociologique ou géographique susceptible d'entraver le respect du protocole de l'étude ou du calendrier de suivi, tel qu'évalué par l'investigateur
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients with LARS > 20 at 3 months after injection
    Proportion de patients avec un LARS > 20 à 3 mois après injection
    E.5.1.1Timepoint(s) of evaluation of this end point
    At 3 months after injection
    A 3 mois après injection
    E.5.2Secondary end point(s)
    - Compliance and tolerance to treatment at 3 months: proportion of patients receiving full treatment, type and frequency of adverse reactions
    - Functional outcome with LARS score at 0, 1, 2, 3 and 6 months
    - Faecal incontinence with Wexner score at 0, 1, 2, 3 and 6 months
    - Quality of life (QLQ-C30 and QLQ-CR29) at 0, 1,3 and 6 months
    - Evaluation of Anxiety profil (STAI-Y trait) at baseline
    - Evaluation of Anxiety profil (STAI-Y state) at 0, 1,3 and 6 months
    - Evaluation of anal sphincter (Anorectal Ultrasound) at inclusion
    - Evaluation and comparison of physiologic tests (manometry and barostat) at 0, 1, 3 and 6 months
    - Proportion of patients with LARS ≤ 20 at 6 months
    - Correlation between LARS and physiologic tests will be analyzed at 0, 1, 2, 3 and 6 months
    - Compliance et tolérance du traitement à 3 mois : proportion des patients recevant la totalité du traitement, type et fréquence des évènements indésirables
    - Résultat fonctionnel (score de LARS) à l’inclusion, 1, 2, 3 et 6 mois
    - Incontinence fécale (score de WEXNER) à l’inclusion, 1, 2, 3 et 6 mois
    - Qualité de vie (QLQ-C30 and QLQ-CR 29) à l’inclusion, 1, 3 et 6 mois
    - Evaluation du profil d’anxiété trait (STAI-Y trait) à l’inclusion
    - Evaluation du profil d’anxiété état (STAI-Y état) à l’inclusion, 1, 3, 6 mois
    - Sphincter anal (Echographie endo-anale) à l’inclusion
    - Evaluation et comparaison des tests physiologiques (manométrie & Barostat) à l’inclusion, 1, 3 et 6 mois.
    - Proportion des patients avec un LARS ≤20 à 6mois
    - Corrélation entre le LARS et les tests physiologique sera analysé à l’inclusion, 1, 3 et 6 mois
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Compliance and tolerance to treatment at 3 months
    - Functional outcome with LARS score at 0, 1, 2, 3 and 6 months
    - Faecal incontinence with Wexner score at 0, 1, 2, 3 and 6 months
    - Quality of life (QLQ-C30 and QLQ-CR29) at 0, 1,3 and 6 months
    - Evaluation of Anxiety profil (STAI-Y trait) at baseline
    - Evaluation of Anxiety profil (STAI-Y state) at 0, 1,3 and 6 months
    - Evaluation of anal sphincter (Anorectal Ultrasound) at inclusion
    - Evaluation and comparison of physiologic tests (manometry and barostat) at 0, 1, 3 and 6 months
    - Proportion of patients with LARS ≤ 20 at 6 months
    - Correlation between LARS and physiologic tests will be analyzed at 0, 1, 2, 3 and 6 months
    - Compliance et tolérance du traitement à 3 mois
    - Résultat fonctionnel (score de LARS) à l’inclusion, 1, 2, 3 et 6 mois
    - Incontinence fécale (score de WEXNER) à l’inclusion, 1, 2, 3 et 6 mois
    - Qualité de vie (QLQ-C30 and QLQ-CR 29) à l’inclusion, 1, 3 et 6 mois
    - Evaluation du profil d’anxiété trait (STAI-Y trait) à l’inclusion
    - Evaluation du profil d’anxiété état (STAI-Y état) à l’inclusion, 1, 3, 6 mois
    - Sphincter anal (Echographie endo-anale) à l’inclusion
    - Evaluation et comparaison des tests physiologiques (manométrie & Barostat) à l’inclusion, 1, 3 et 6 mois.
    - Proportion des patients avec un LARS ≤20 à 6mois
    - Corrélation entre le LARS et les tests physiologique sera analysé à l’inclusion, 1, 3 et 6 mois
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    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
    Dernière Visite du Dernier Patient inclus (DVDP)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months18
    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: 5
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 state20
    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 Decision2021-05-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-06-17
    P. End of Trial
    P.End of Trial StatusCompleted
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