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    Summary
    EudraCT Number:2017-001216-11
    Sponsor's Protocol Code Number:FISAN-BOT-2017-01
    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:2017-04-07
    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 number2017-001216-11
    A.3Full title of the trial
    Usefulness of botulinum toxin type A in the treatment of chronic anal fissure
    Utilidad de la toxina botulínica tipo A en el tratamiento de la fisura anal crónica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    botulinum toxin for the treatment of chronic anal fissure
    Toxina botulínica para el tratamiento de la fisura anal crónica
    A.4.1Sponsor's protocol code numberFISAN-BOT-2017-01
    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 SponsorDra. A. Teresa Calderón Duque
    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 supportNA
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital Nuestra Sra. del Prado
    B.5.2Functional name of contact pointDra. Pilar Cruz y Dra Laura Arriero
    B.5.3 Address:
    B.5.3.1Street AddressCarretera de Madrid, Km. 114,
    B.5.3.2Town/ cityTALAVERA DE LA REINA (Toledo)
    B.5.3.3Post code45600
    B.5.3.4CountrySpain
    B.5.6E-mailpilarc11@hotmail.com
    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 Xeomin®
    D.2.1.1.2Name of the Marketing Authorisation holderMerz Pharma España S.L.
    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.3.1Product nameIncobotulinumtoxinA
    D.3.2Product code IncobotulinumtoxinA
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    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.3.9.2Current sponsor codeFISAN-BOT-2017-01
    D.3.9.3Other descriptive nameBOTULINUM TOXIN TYPE A
    D.3.9.4EV Substance CodeSUB13117MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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
    Chronic anal fissure
    Fisura anal crónica
    E.1.1.1Medical condition in easily understood language
    Chronic anal fissure
    Fisura anal crónica
    E.1.1.2Therapeutic area Not possible to specify
    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
    Assess the cure rate of chronic anal fissure with botulinum toxin in 2 years of follow-up
    Valorar la tasa de curación de la fisura anal crónica con toxina botulínica en un seguimiento de 2 años
    E.2.2Secondary objectives of the trial
    * Determine the effect of botulinum toxin A (incobotulinumtoxinA) on the relaxation of the internal anal sphincter in patients with chronic anal fissure.
    * Assess pain control with botulinum toxin.
    * Determine what type of complications may appear with botulinum toxin treatment and estimate their proportion.
    * Establish prognostic factors in the failure of treatment of chronic anal fissure with botulinum toxin.
    * Calculate the risk profiles for the emergence of complications.
    * Estimate the median time in the emergence of failure.
    * Know the percentage of patients in whom a surgical treatment could be avoided, through the use of this therapy.
    * Assess quality of life before and after using the toxin.
    *Determinar el efecto de la toxina botulínica A (incobotulinumtoxinA) en la relajación del esfínter anal interno en pacientes con fisura anal crónica.
    *Valorar el control del dolor con toxina botulínica.
    *Determinar qué tipo de complicaciones pueden aparecer con el tratamiento con toxina botulínica y estimar su proporción.
    *Establecer los factores pronósticos en el fracaso del tratamiento de la fisura anal crónica con toxina botulínica.
    *Calcular los perfiles de riesgo para la aparición de complicaciones.
    *Estimar el tiempo mediano en la aparición del fracaso.
    *Conocer el porcentaje de pacientes en los que se podría evitar un tratamiento quirúrgico, mediante el uso de esta terapia.
    *Valorar calidad de vida antes y después del uso de la toxina.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    * Patients seen in the clinical Surgery Consultation with diagnosis of chronic anal fissure.
    * Patients older than 18 years of age with a diagnostic of fissure of more than two months of evolution who have not responded to previous anal fissure medical treatments. Medical treatment would consist of hygienic dietary measures and systemic and local analgesic treatment with ointments (Annex 1). These ointments will be either calcium antagonists (Diltiazem 2%) or nitrates (Rectogesic 0.4%), whose main function is to relax the smooth muscle of the anus. This treatment should be prescribed for 6-8 weeks before assessing whether or not there has been healing or improvement
    *Pacientes que acudan a la Consulta de Cirugía con diagnóstico de fisura anal crónica.
    * Pacientes mayores de 18 años de edad con clínica de fisura de más de dos meses de evolución que no han respondido a tratamientos médicos de fisura anal previos. El tratamiento médico consistiría en medidas higiénico dietéticas y tratamiento analgésico sistémico y local con pomadas (Anexo 1). Estas pomadas serán bien calcio antagonistas (Diltiazem 2%) o nitratos (Rectogesic 0.4%), ambas con función relajante del músculo liso del ano por distintas vías de actuación. Este tratamiento debe prescribirse durante 6-8 semanas antes de valorar si se ha producido o no curación o mejoría.
    E.4Principal exclusion criteria
    *Minors
    *Patients with diagnosis of chronic anal fissure that it isn’t idiopathic.
    * Patients who have not previously received medical treatment for the anal fissure.
    * Patients with contraindication to the use of Botulinum Toxin type A: Myasthenia gravis, Eaton-Lambert syndrome, pregnant women, acelticoline deficiency.
    *Menores de edad.
    *Pacientes con diagnóstico de fisura anal crónica que no sea idiopática.
    *Pacientes que no hayan recibido previamente tratamiento médico para la fisura anal.
    *Pacientes con contraindicación para el uso de la Toxina botulínica tipo A: Miastenia gravis, síndrome Eaton-Lambert, embarazadas, déficit de acelticolina.
    E.5 End points
    E.5.1Primary end point(s)
    Recovery will be defined, when the fissure is healed and without symptoms; Improvement, when the fissure endures without symptons; and failure when both fissure and symptoms endure. In the last group, patients who required surgical management, will be included.
    Se definirá curación, cuando la fisura esté cicatrizada y sin clínica; mejoría, cuando la fisura persista en ausencia de síntomas; y fracaso cuando persistan la fisura y los síntomas. En este último grupo, se incluirá a los pacientes que por su sintomatología requirieron manejo quirúrgico.
    E.5.1.1Timepoint(s) of evaluation of this end point
    2 years
    2 años
    E.5.2Secondary end point(s)
    Efficacy: We will evaluate the pain with EVA scale, exhaust gases and feces and physical examination to see if the lession has dissapeared. Also, we will do a control manometry and ecography at 1 and 3 months after the treatment. Patients will be followed up at the clinical surgery consultation for two years. Recurrence of chronic anal fissure after the follow-up period will be defined as treatment failure.
    Eficacia: Se evaluarán a la semana el dolor mediante la escala EVA, escape de gases y heces y la exploración física objetivando si hay desaparición de la lesión, así como también al mes y tres meses donde se incluirá además la realización de manometría control y ecografía. Se efectuará seguimiento a los pacientes en la Consulta de Cirugía durante dos años para comprobar recurrencia o no del proceso. Se definirá como fracaso al tratamiento la recidiva de la fisura anal crónica tras el periodo de seguimiento.
    E.5.2.1Timepoint(s) of evaluation of this end point
    2 years
    2 años
    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 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 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 Yes
    E.8.1.7.1Other trial design description
    Estudio de tipo prospectivo de cohorte única
    Prospective study of a single cohort
    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
    ultima visita ultimo paciente
    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 months24
    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) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state100
    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
    ninguno
    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 Decision2017-04-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-04-21
    P. End of Trial
    P.End of Trial StatusOngoing
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