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    Summary
    EudraCT Number:2010-024028-24
    Sponsor's Protocol Code Number:IBS-PTX
    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:2012-01-11
    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 number2010-024028-24
    A.3Full title of the trial
    EFFECT OF PENTOXIFYLLINE ON THE TIGHT JUNCTIONS (TJs) OF THE INTESTINAL MUCOSA IN PATIENTS WITH IRRITABLE BOWEL SYNDROME (IBS).
    EFECTO DE LA PENTOXIFILINA EN LAS UNIONES ESTRECHAS (TJs) DE LA MUCOSA INTESTINAL EN PACIENTES CON SINDROME DE INTESTINO IRRITABLE (SII).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    EFFECT OF PENTOXIFYLLINE IN PATIENTS WITH IRRITABLE BOWEL SYNDROME (IBS).
    EFECTO DE LA PENTOXIFILINA EN PACIENTES CON SINDROME DE INTESTINO IRRITABLE (SII).
    A.3.2Name or abbreviated title of the trial where available
    IBS-PTX
    IBS-PTX
    A.4.1Sponsor's protocol code numberIBS-PTX
    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 Canarias
    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 supportNO
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFUNDACIÓN RAFAEL CLAVIJO
    B.5.2Functional name of contact pointUCICEC
    B.5.3 Address:
    B.5.3.1Street AddressHospital Universitario de Canarias. PLANTA 1ª. Ofra s/n. La Cuesta
    B.5.3.2Town/ cityLa Laguna
    B.5.3.3Post code38320
    B.5.3.4CountrySpain
    B.5.4Telephone number+34922678115
    B.5.5Fax number+34922647112
    B.5.6E-maila.aldea@gmail.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 HEMOVÁS
    D.2.1.1.2Name of the Marketing Authorisation holderFERRER-GROUP LABORATORY
    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 namepentoxifylline
    D.3.2Product code pentoxifylline
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPentoxifilline
    D.3.9.2Current sponsor code2010-024028-24
    D.3.9.3Other descriptive namePentoxifilline
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet for oral suspension
    D.8.4Route of administration of the placeboBuccal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    IRRITABLE BOWEL SYNDROME (IBS) generates tomach pain and changes in depositions number and consistency. IBS has a high prevalence in Digestive consultations. In spite of this, we haven´t good treatments to avoid cronic and recurrents symptoms.
    Síndrome de intestino irritable (SII) se caracteriza por dolor abdominal y un cambio en el número y/o consistencia de deposiciones. SII tiene una elevada prevalencia en las consultas del especialista de Digestivo. A pesar del importante número de pacientes afectos, no disponemos de tratamientos eficaces para remitir estos síntomas crónicos y recidivantes.
    E.1.1.1Medical condition in easily understood language
    IRRITABLE BOWEL SYNDROME (IBS) generates a lot of unconfortables symptoms. It´s the most frecuent diagnosis in Digestive consultations. No exist good treatments to avoid it.
    Síndrome de intestino irritable (SII) genera muchos síntomas incómodos. Es el diagnóstico más frecuente en las consultas del Aparato Digestivo. No existen tratamientos para evitarlos.
    E.1.1.2Therapeutic area Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
    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
    Determine the therapeutic effectiveness of treatment with oral pentoxifiline in the severity and the clinic evolution of patient with IBS.
    Determinar la eficacia terapéutica del tratamiento con pentoxifilina oral en la severidad y la evolución clínica de pacientes con SII.
    E.2.2Secondary objectives of the trial
    Research the effect os treatment with pentoxifiline
    Investigar el efecto del tratamiento con pentoxifilina
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    P atients from 18 to 65 years old and with capacity to give informed consent.
    The patients with IBS are belong that patients who come to Digestive consultation from our center.
    Patients must have a monitoring at least 6 months before the inclussion.
    Achive the Roma III criterions for IBS (Gastroenterology 2006;130:1377-90) with moderate-severe gravity according to Francis modificated scale.
    Patients could not have any alergic pathology or gastrointestinals illness.
    Women with fertile age no pregnant (proven blood or urine test in visit of selection) and use methods of contraception at least from 14 days before first dose of medicine until 14 days after last dose of medicine.
    Pacientes de 18 a 65 años y con capacidad para otorgar su consentimiento informado. Los pacientes con SII pertenecerán a las consultas externas ambulatorias de Aparato Digestivo de nuestro centro.
    Los pacientes tendrán un seguimiento clínico durante al menos 6 meses previos a su inclusión.
    Cumplir los criterios de Roma III para SII (Gastroenterology 2006;130:1377-90) con una gravedad moderada-severa según valoración por escala modificada de Francis (ver descripción posterior).
    Los participantes no presentarán patología alérgica ni otras enfermedades gastrointestinales.
    Las mujeres en edad fértil deberán obtener un resultado negativo en la prueba de embarazo en suero o en orina en la visita de selección, y aceptar el empleo de métodos anticonceptivos adecuados al menos desde los 14 días previos a la primera dosis del fármaco de estudio hasta los 14 siguientes a la última.
    E.4Principal exclusion criteria
    Patients can not take Salicylates, NSAIDs, antibiotics,anticholinergic, Opiates or any other medication or product
    use for diarrea sintomatic treathment two weeks before biopsia. Besides, others medications as corticoid, antihistamine or immunosuppressives can not be taken 3 months before the colon biopsia.
    Patients who had recibed radiotherapy or chemotherapy 6 months before the study.
    Alergic reactions to pentoxifiline, pregnancy, kidney or hepatic severe failure or any mental or legal disability to sign informed consent .
    Pregnant or while breastfeeding.
    All cases where medicine in research is contraindicated by medicine technical data
    Los pacientes no podrán tomar salicilatos, AINES, antibióticos, anticolinérgicos, opiáceos y cualquier otra medicación o producto usados para el tratamiento sintomático de la diarrea, en las 2 semanas previas a la biopsia. Además el empleo de otras medicaciones como corticoides, antihistamínicos o inmunosupresores, no se permitirá en los 3 meses previos a la realización de la biopsia de colon.
    Pacientes que hayan recibido radioterapia o quimioterapia en los 6 meses previos al estudio.
    Reacciones alérgicas a la pentoxifilina, el embarazo, insuficiencia renal o hepática grave y en cualquier caso la incapacidad mental o legal para firmar el consentimiento.
    Mujeres embarazadas o en período de lactancia.
    Todos los casos en los que está contraindicado el uso del medicamento en investigación según la ficha técnica del mismo.
    E.5 End points
    E.5.1Primary end point(s)
    Main variable will be the assessment of IBS clinic evolution and severity.
    La variable principal será la evaluación de la evolución clínica y de la severidad del SII.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 year
    1 año
    E.5.2Secondary end point(s)
    assessment of biologic effect of treatment with PTX
    Valorar el efecto biológico del tratamiento con PTX
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 year
    1 año
    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 No
    E.6.5Efficacy Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 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 Yes
    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 when we had the 59 pacients included and studied during a year.
    In the case where it will be not the last visit of the last subject undergoing the trial, we will write a justification and take care for the patients (rigth treatment and medication)
    El fin del estudió será cuando tengamos los 59 pacientes incluidos y estudiados en un año.
    En caso de no poder incluir todos los pacientes, realizaremos una justificación por escrito y nos encargaremos de que los pacientes reciban los cuidados adecuados (correctos tratamiento y medicamentos)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    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: 59
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2012-01-11. Yes
    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 state59
    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)
    Follows with treatment before or none if it´s successful
    Continuar con su tratamiento anterior o ninguno si es exitoso
    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 Decision2012-05-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-02-24
    P. End of Trial
    P.End of Trial StatusOngoing
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