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    Summary
    EudraCT Number:2021-002819-60
    Sponsor's Protocol Code Number:FAC-BOTOX
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-06-23
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2021-002819-60
    A.3Full title of the trial
    Treatment of chronic anal fissure with ultrasound-guided intersphincteric infiltration of botulinum toxin A.
    Tratamiento de la fisura anal crónica con infiltraciones interesfinterianas ecoguiadas de toxina botulínica A
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment of chronic anal fissure with ultrasound-guided intersphincteric infiltration of botulinum toxin A.
    Tratamiento de la fisura anal crónica con infiltraciones interesfinterianas ecoguiadas de toxina botulínica A
    A.4.1Sponsor's protocol code numberFAC-BOTOX
    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 SponsorHospital Universitario de Burgos
    B.1.3.4CountrySpain
    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 supportHospital Universitario de Burgos
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUnidad de Investigación, Hospital Universitario de Burgos
    B.5.2Functional name of contact pointMiriam Saiz
    B.5.3 Address:
    B.5.3.1Street AddressAvda Islas Baleares 3
    B.5.3.2Town/ cityBurgos
    B.5.3.3Post code09006
    B.5.3.4CountrySpain
    B.5.6E-mailmsaiz@hubu.es
    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
    D.2.1.1.2Name of the Marketing Authorisation holderAllergan
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInfiltration
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBotulinum Toxin Type A
    D.3.9.1CAS number 93384-43-1
    D.3.9.3Other descriptive nameBOTULINUM TOXIN TYPE A
    D.3.9.4EV Substance CodeSUB13117MIG
    D.3.10 Strength
    D.3.10.1Concentration unit U unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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) Yes
    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
    Chronic anal fissure
    Fisura anal crónica
    E.1.1.1Medical condition in easily understood language
    Chronic anal fissure
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
    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 whether the technique of ultrasound-guided botulinum toxin infiltration is more effective and safer than the standard one, by controlling the infiltration sites.
    The aim is to analyze whether the location of the botulinum toxin infiltration is an important factor in the result of the treatment.
    On the other hand, the aim is to standardize a technique and make it much more precise for the localization of the infiltration, through the use of the endorectal ultrasound probe. Therefore, our objective is to establish a novel technique that complements the standard technique, is reproducible and does not increase the risks and is even safer, as it controls the site of toxin infiltration.
    Valorar si la técnica de infiltración de toxina botulínica ecoguiada es más efectiva, y segura que la estándar, al controlar los puntos de infiltración.
    Se trata de analizar si la localización de la infiltración de la toxina botulínica es un factor importante en el resultado del tratamiento. porcentaje de valorar si el
    Por otro lado, se busca estandarizar una técnica y hacerla mucho más precisa para la localización de la infiltración, mediante el uso de la sonda ecográfica endorrectal. Por tanto, nuestro objetivo es instaurar una técnica novedosa que complementa a la técnica estándar, reproducible y que no incrementa los riesgos siendo incluso más segura, al controlar el lugar de la infiltración de la toxina
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    All patients of legal age who sign the informed consent form and are diagnosed with chronic anal fissure will be included in the study. Chronic anal fissure will be considered as that which has been evolving for more than 6 weeks, in spite of various hygienic-dietary treatments and/or relaxants (NTG) or calcium blockers and which macroscopically presents some of the aspects of chronicity referred to: indurated edges, observation in the fundus of internal anal sphincter fibers and/or sentinel polyp persisting for more than 6 weeks.
    Se incluirán en el estudio todos aquellos pacientes mayores de edad, que firmen el consentimiento informado y estén diagnosticados de fisura anal crónica. Se considerará fisura anal crónica a aquella que lleva más de 6 semanas de evolución, a pesar de diversos tratamientos higiénico-dietéticos y/o relajantes (NTG) o bloqueadores del calcio y que macroscópicamente presenta alguno de los aspectos de cronicidad referidos: bordes indurados, observación en el fondo de fibras de EAI y /o pólipo centinela que persista más de 6 semanas.
    E.4Principal exclusion criteria
    Patients in whom botulinum toxin injection is contraindicated are excluded from the study: patients with alterations of neuromuscular transmission such as myasthenia gravis, Lambert Eaton myasthenic syndrome, inflammatory bowel disease, concomitant treatment with aminoglycosides, pregnancy or lactation, asthma or adverse reactions to treatment.
    Estarán excluidos del estudio los pacientes en que está contraindicada la inyección de toxina botulínica: pacientes con alteraciones de la transmisión neuromusculares como miastenia gravis, síndrome miasténico Lambert Eaton, Enfermedad Inflamatoria intestinal. tratamiento concomitante con aminoglucósidos, embarazo o lactancia, asma o reacciones adversas al tratamiento
    E.5 End points
    E.5.1Primary end point(s)
    The main variables that we will specify in the study will be whether there is healing of the fissure (epithelialization of the fissure and disappearance of symptoms such as pain or bleeding), that there is no recurrence and, finally, to assess the complications of treatment (mainly anal incontinence), especially anal incontinence.
    Las principales variables que precisaremos en el estudio serán, si existe curación de la fisura, (epitelización de la misma y desaparición de la sintomatología como el dolor o el sangrado), que no haya recidiva y, por último, valorar las complicaciones del tratamiento (fundamentalmente la incontinencia anal) sobre todo la incontinencia anal.
    E.5.1.1Timepoint(s) of evaluation of this end point
    2, 8 and 24 weeks
    2, 8 y 24 semanas
    E.5.2Secondary end point(s)
    Not applicable
    E.5.2.1Timepoint(s) of evaluation of this end point
    not applicable
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    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 Yes
    E.8.2.3.1Comparator description
    Usual clinical practice
    E.8.2.4Number of treatment arms in the trial2
    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
    The end of the trial will be the last follow-up visit of the last included patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    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: 50
    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 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 state50
    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 Decision2021-08-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-06-19
    P. End of Trial
    P.End of Trial StatusOngoing
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