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    Summary
    EudraCT Number:2007-005914-38
    Sponsor's Protocol Code Number:IBS-CGD
    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:2008-03-07
    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 number2007-005914-38
    A.3Full title of the trial
    Efecto de la estabilización prolongada del mastocito intestinal con cromoglicato disódico en la evolución clínica y la microinflamación de la mucosa intestinal en los pacientes con síndrome de intestino irritable tipo diarrea.
    A.4.1Sponsor's protocol code numberIBS-CGD
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorServicio de Digetivo del Hospital Valle Hebrón del Instituto Catalán de Salud. NIF Q5855029D
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Gastrofenal
    D.2.1.1.2Name of the Marketing Authorisation holderSigma-Tau España S.A.
    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 Capsule*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNcromoglicato disódico
    D.3.9.1CAS number 15826376
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100.8
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 Information not present in EudraCT
    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 placeboCapsule*
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Sindrome de intestino irritable
    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
    Analizar el impacto que tiene el efecto de un agente estabilizador del mastocito, cromoglicato disódico, en la evolución clínica de los pacientes con síndrome de intestino irritable con predominio de diarrea, con el objetivo inmediato de poder ofrecer una alternativa válida, eficaz y segura para el tratamiento de esta patología tan frecuente.
    E.2.2Secondary objectives of the trial
    a.- Investigar y estudiar los mecanismos fisiopatológicos implicados en la respuesta terapéutica, y para ello se analizará el efecto de la estabilización prolongada de los mastocitos en la inflamación microscópica de la mucosa intestinal comparando para ello los cambios, antes y después del tratamiento, en:
    -la morfología epitelial en el yeyuno
    -el número de mastocitos y linfocitos intraepiteliales
    -los patrones de degranulación mastocitaria y porcentaje de células activadas
    -los mediadores intracitoplasmáticos y activación/supresión de genes del mastocito
    -la liberación de mediadores inflamatorios en sangre periférica y fluido intestinal
    -los cambios en la flora intestinal
    -cambios en la expresión génica en la mucosa yeyunal
    b.- Analizar el grado de influencia en la respuesta terapéutica de variables demográficas como sexo, edad, niveles del fármaco en sangre y niveles de estrés.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    · Edad comprendida entre los 18-65 años.
    · Firma del consentimiento informado.
    · Pruebas de alergia alimentaria pricks cutáneos a alergenos alimentarios y pneumoalergenos negativos.
    · Diagnóstico de síndrome de intestino irritable según los criterios de Roma III en los últimos 6-12 meses.
    · Ausencia de embarazo.
    · Ausencia de otras enfermedades gastrointestinales que cursen con diarrea crónica especialmente descartando enfermedad celíaca.
    · Nivel de T3, T4 y TSH normal.
    · Inicio de la enfermedad no relacionado con enfermedad infecciosa.
    E.4Principal exclusion criteria
    · Edad <18 o >65 años.
    · Reacciones alérgicas o anafilácticas al cromoglicato.
    · Toma de corticoides o inmunosupresores, en los 6 meses previos a la realización de la biopsia intestinal.
    · Toma de estabilizadores del mastocito como el ketotifeno, nedocromil, anticolinérgicos, antihistamínicos, antiserotoninérgicos o antidepresivos en el mes previo a la biopsia.
    · Toma de salicilatos, AINES, β2-agonistas, acetaminofeno, antiácidos, codeína o derivados opioides en las 2 semanas previas a la biopsia.
    · Tratamiento con radioterapia o quimioterapia en los 6 meses previos a la inclusión.
    · Embarazo.
    · Diabetes Mellitus.
    · Hipertiroidismo.
    · Resección intestinal (excepto apendicectomía o divertículo de Meckel)
    · Incapacidad mental o legal para firmar el consentimiento.
    · Alergia alimentaria.
    · Retirada voluntaria
    · Pérdida de seguimiento
    · Violación del protocolo
    · Reacción adversa grave
    · Psicopatías que requieran tratamiento farmacológico
    E.5 End points
    E.5.1Primary end point(s)
    La variable principal a estudiar es la proporción de pacientes que presentan una mejoría significativa en la evolución clínica expresada en forma de dolor abdominal y consistencia de las deposiciones recogidas como variable cuantitativa mediante escalas graduadas, tras el tratamiento con un agente estabilizador de la membrana del mastocito, cromoglicato disódico, en los pacientes con síndrome de intestino irritable y predominio de diarrea.
    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 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) Information not present in EudraCT
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Information not present in EudraCT
    E.7.3Therapeutic confirmatory (Phase III) Information not present in EudraCT
    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 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.8.3 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 Information not present in EudraCT
    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
    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 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.1.3Elderly (>=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 state64
    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 Decision2008-05-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-12-10
    P. End of Trial
    P.End of Trial StatusOngoing
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