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    Summary
    EudraCT Number:2013-001912-31
    Sponsor's Protocol Code Number:BUG-3/MIC
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-12-02
    Trial results View 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 number2013-001912-31
    A.3Full title of the trial
    Randomised, double-blind, placebo-controlled, multi-centre trial on the efficacy and safety of budesonide for induction of remission in incomplete microscopic colitis
    Estudio aleatorizado, doble-ciego, controlado con placebo y multicéntrico sobre la eficacia y la seguridad de budesonida para inducir la remisión en la colitis microscópica incompleta
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Randomised, double-blind, placebo-controlled, multi-centre trial on the efficacy and safety of budesonide for induction of remission in incomplete microscopic colitis
    Estudio aleatorizado, doble-ciego, controlado con placebo y multicéntrico sobre la eficacia y la seguridad de budesonida para inducir la remisión en la colitis microscópica incompleta
    A.3.2Name or abbreviated title of the trial where available
    Budesonide for induction of remission in incomplete microscopic colitis
    Budesonida para inducir la remisión en la colitis microscópica incompleta
    A.4.1Sponsor's protocol code numberBUG-3/MIC
    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 SponsorDr. Falk Pharma GmbH
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportDr. Falk Pharma GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDr. Falk Pharma GmbH
    B.5.2Functional name of contact pointClinical Research and Development
    B.5.3 Address:
    B.5.3.1Street AddressLeinenweberstr. 5
    B.5.3.2Town/ cityFreiburg
    B.5.3.3Post code79108
    B.5.3.4CountryGermany
    B.5.4Telephone number++4976115140
    B.5.5Fax number++497611514377
    B.5.6E-mailmohrbacher@drfalkpharma.de
    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 Budenofalk® 9 mg gastro-resistant granules
    D.2.1.1.2Name of the Marketing Authorisation holderDr. Falk Pharma GmbH
    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 nameBudenofalk® 9 mg gastro-resistant granules
    D.3.2Product code Budenofalk
    D.3.4Pharmaceutical form Gastro-resistant granules
    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 INNBUDESONIDE
    D.3.9.1CAS number 51333-22-3
    D.3.9.3Other descriptive nameBudenofalk
    D.3.9.4EV Substance CodeSUB05955MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number9
    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 placeboGastro-resistant granules
    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
    Patients with active incomplete microscopic colitis
    Pacientes con colitis microcóspica incompleta activa
    E.1.1.1Medical condition in easily understood language
    Patients with active incomplete microscopic colitis
    Pacientes con colitis microcóspica incompleta activa
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10056979
    E.1.2Term Colitis microscopic
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the trial is to demonstrate efficacy of budesonide for induction of remission in patients with active incomplete microscopic colitis
    El objetivo primario del ensayo es demostrar la eficacia de budesonida para inducir la remisión de la colitis microscópica incompleta activa después de 8 semanas de tratamiento
    E.2.2Secondary objectives of the trial
    - To study the maintenance of remission after end of treatment
    - To study safety and tolerability of budesonide
    - To assess patients? health related quality of life
    - To assess the proportion of patients that fulfil the criteria for irritable bowel syndrome (ROME III criteria)
    - Estudiar el mantenimiento de la remisión después del final del tratamiento
    - Estudiar la seguridad y la tolerabilidad de budesonida
    - Evaluar la calidad de vida relacionada con la salud de los pacientes
    - Evaluar el porcentaje de pacientes que cumplen los criterios del síndrome del intestino irritable (criterios ROMA III)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Signed informed consent,
    2.Man or woman between 18 and 80 years of age,
    3.Histologically established diagnosis of incomplete microscopic colitis (MCi) defined as the following findings in at least two segments of the colon:
    - increased lymphoplasmacellular infiltrate in the lamina propria and
    - thickened subepithelial collagenous band > 5 ?m and < 10 ?m and/or
    - abnormal intraepithelial lymphocytes > 5 and < 20 per 100 epithelial cells,
    4.History of chronic non-bloody, watery diarrhoea for at least 4 weeks,
    5.Clinically active disease (defined as a mean of ? 3 stools/day, thereof a mean of ? 1 watery stool/day during the week prior to randomisation),
    6.Women of child-bearing potential have to apply during the entire duration of the study a highly effective method of birth control, which is defined as those which result in a low failure rate (i.e., less than 1% per year) when used constantly and correctly such as implants, injectables, combined oral contraceptive method, some IUDs, sexual abstinence or vasectomised partner. The investigator is responsible for determining whether the patient uses adequate birth control for study participation.
    1.Consentimiento informado firmado,
    2.Hombres y mujeres de 18 a 80 años de edad,
    3.Diagnóstico histológico confirmado de colitis microscópica incompleta (CMi), definida por los siguientes hallazgos como mínimo en dos segmentos del colon:
    - Aumento del infiltrado linfoplasmocelular en la lámina propia y
    - Engrosamiento de la banda de colágeno subepitelial > 5 ?m y < 10 ?m y/o
    - Número de linfocitos intraepiteliales anormales > 5 y < 20 por cada 100 células epiteliales,
    4.Antecedentes de diarrea líquida sin sangre durante al menos 4 semanas,
    5.Enfermedad clínicamente activa (definida como una media ? 3 deposiciones/día y, de ellas, una media ? 1 deposiciones líquidas/día durante la semana previa a la aleatorización),
    6.Las mujeres fértiles deberán utilizar durante todo el estudio un método anticonceptivo eficaz, que se define como un método con una tasa baja de fallo (menor del 1% al año) cuando se usa de forma constante y correcta, como implantes, inyectables, anticonceptivos orales combinados, ciertos tipos de DIU, abstinencia sexual o pareja vasectomizada. El investigador es el responsable de averiguar si la paciente utiliza el anticonceptivo adecuado durante la participación en el estudio.
    E.4Principal exclusion criteria
    1.Other significant abnormalities in colonoscopy that may have been the cause of diarrhoea except for colonic diverticulosis and non-dysplastic polyps < 2 cm,
    2.Infectious cause of diarrhoea (local routine stool samples, Clostridium difficile included) or history of infectious diarrhoea within the last 3 months prior inclusion or local intestinal infection,
    3.Clinical suspicion of drug-induced diarrhoea,
    4.Prior and present MC (i.e., all histological criteria for collagenous colitis or lymphocytic colitis fulfilled),
    5.History of bowel resection,
    6.Radiation therapy of the abdominal or pelvic region,
    7.Positive antibody titres for celiac disease (tGT IgA + serum IgA),
    8.Untreated active thyroid dysfunction,
    9.Any severe concomitant cardiovascular, renal, endocrine, or psychiatric disorder reducing life expectancy,
    10.Abnormal hepatic function (ALT or ALP > 2.5 x upper limit of normal [ULN]), liver cirrhosis, or portal hypertension,
    11.Tuberculosis, hypertension, diabetes mellitus, osteoporosis, peptic ulcer disease, glaucoma, cataract, or infection if careful medical monitoring is not ensured,
    12.History of colorectal cancer,
    13.History of cancer (other than colorectal) in the last 5 years,
    14.Therapy with immunomodulators (e.g., azathioprine, 6-mercaptopurine, or methotrexate) within 3 months prior to baseline,
    15.Treatment with budesonide or other steroids within 4 weeks prior to baseline,
    16.Treatment with antibiotics within 4 weeks prior to baseline,
    17.Treatment with anti-diarrhoeal drugs (e.g., loperamide, ispaghula, codeine, and opium), cholestyramine, bulking agents, and spasmolytics within 2 weeks prior to baseline,
    18.Known intolerance/hypersensitivity/resistance to the trial drug or drugs of similar chemical structure or pharmacological profile,
    19.Current or intended pregnancy or breast-feeding,
    20.Doubt about the patients cooperation, e.g. because of addiction to alcohol or drugs,
    21.Participation in another clinical trial within the last 30 days, simultaneous participation in another clinical trial, or previous participation in this trial.
    1.Otras anomalías significativas detectadas en la colonoscopia que puedan haber sido la causa de la diarrea, excepto diverticulosis colónica y pólipos no displásicos < 2 cm,
    2.Diarrea de origen infeccioso (análisis de muestras fecales de acuerdo con criterios locales, incluida Clostridium difficile) o antecedentes de diarrea infecciosa en los 3 meses previos a la inclusión o infección intestinal local,
    3.Sospecha clínica de diarrea medicamentosa,
    4.CM pasada o presente (es decir, cumplimiento de todos los criterios histológicos de colitis colágena o colitis linfocítica),
    5.Antecedentes de resección intestinal,
    6.Radioterapia en la región abdominal o pélvica,
    7.Presencia de anticuerpos indicadores de celiaquía (IgA contra TGt + IgA en suero),
    8.Disfunción tiroidea activa no tratada,
    9.Cualquier trastorno concomitante grave de naturaleza cardiovascular, renal, endocrina o psiquiátrica que reduzca la esperanza de vida,
    10.Función hepática anormal (ALT o ALP > 2,5 x límite superior de la normalidad [LSN]), cirrosis hepática o hipertensión portal,
    11.Tuberculosis, hipertensión, diabetes mellitus, osteoporosis, úlcera péptica, glaucoma, cataratas o infección si hay dudas de que el paciente tenga una monitorización médica estrecha,
    12.Antecedentes de cáncer colorrectal,
    13.Antecedentes de cáncer de otro tipo en los últimos 5 años,
    14.Tratamiento con inmunomoduladores (p. ej., azatioprina, 6-mercaptopurina o metotrexato) durante los 3 meses previos al periodo basal,
    15.Tratamiento con budesonida u otros corticosteroides durante las 4 semanas previas al periodo basal,
    16.Tratamiento con antibióticos en las 4 semanas previas al periodo basal,
    17.Tratamiento con antidiarreicos (p. ej., loperamida, ispágula, codeína, opio), colestiramina, laxantes formadores de masa y espasmolíticos durante las 2 semanas previas al periodo basal,
    18.Intolerancia, hipersensibilidad o resistencia conocida al fármaco del estudio o a fármacos de estructura química o características farmacológicas similares,
    19.Mujeres embarazadas o que quieran quedarse embarazadas y mujeres en período de lactancia,
    20.Dudas sobre la colaboración del paciente, por ejemplo debido a una adicción al alcohol o a drogas,
    21.Participación en otro ensayo clínico durante los últimos 30 días, participación simultánea en otro ensayo clínico o haber participado antes en este mismo ensayo.
    E.5 End points
    E.5.1Primary end point(s)
    Rate of clinical remission at final/withdrawal visit
    Tasa de remisión clínica en la visita final/de retirada
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 8 weeks of treatment
    Después de 8 semanas de tratamiento
    E.5.2Secondary end point(s)
    Double-blind phase:
    - Rate of clinical remission at V2 and V3
    - Time to remission
    - Total number of stools in the week prior to V2, V3, V4/withdrawal and change from baseline
    - Number of formed stools in the week prior to V2, V3, V4/withdrawal and change from baseline
    - Number of soft stools in the week prior to V2, V3, V4/withdrawal and change from baseline
    - Number of watery stools in the week prior to V2, V3, V4/withdrawal and change from baseline
    - Number of days with abdominal pain in the week prior to V2, V3, V4/withdrawal and change from baseline
    - Number of urgent stools in the week prior to V2, V3, V4/withdrawal and change from baseline
    - Number of stools with urgency grade 3 (have to go immediately to the toilette) in the week prior to V2, V3, V4/withdrawal and change from baseline
    - Number of stools with difficulties staying continent in the week prior to V2, V3, V4/withdrawal and change from baseline
    - Number of days with bloating in the week prior to V2, V3, V4/withdrawal and change from baseline
    - Changes from baseline of histological signs (inflammation of the lamina propria, thickness of the subepithelial collagen band, number of IELs in the surface epithelium, degeneration of the surface epithelium) at V4/withdrawal
    - Rate of histological remission as defined 6.4.7 at V4/withdrawal
    - Rate of histological improvement/no change/aggravation as defined in 6.4.7 at V4/withdrawal
    - Physician?s Global Assessment (PGA) at V4/withdrawal
    - Short Health Scale (SHS) dimensions symptom burden, social function, disease-related worry and general well-being at V2, V3, V4/withdrawal and change from baseline

    Follow-up phase:
    - Rate of responders maintaining clinical remission at FU1 and FU2
    - Rate of patients with relapse at FU1 and FU2
    (relapse defined as a mean of ? 3 stools/day and thereof a mean of ? 1 watery stool/day during at least one week)
    - Time to relapse
    Fase de doble-ciego:
    - Tasa de remisión clínica en las visitas V2 y V3
    - Tiempo hasta la remisión
    - Número total de deposiciones en la semana anterior a las visitas V2, V3, V4/retirada y cambio respecto al periodo basal
    - Número de deposiciones sólidas en la semana anterior a las visitas V2, V3, V4/retirada y cambio respecto al periodo basal
    - Número de deposiciones blandas en la semana anterior a las visitas V2, V3, V4/retirada y cambio respecto al periodo basal
    - Número de deposiciones líquidas en la semana anterior a las visitas V2, V3, V4/retirada y cambio respecto al periodo basal
    - Número de días con dolor abdominal en la semana anterior a las visitas V2, V3, V4/retirada y cambio respecto al periodo basal
    - Número de episodios de urgencia defecatoria en la semana anterior a las visitas V2, V3, V4/retirada y cambio respecto al periodo basal
    - Número de deposiciones con urgencia de grado 3 (necesidad imperiosa de ir al aseo) en la semana anterior a las visitas V2, V3, V4/retirada y cambio respecto al periodo basal
    - Número de deposiciones con dificultades para mantener la continencia en la semana anterior a las visitas V2, V3, V4/retirada y cambio respecto al periodo basal
    - Número de días con meteorismo en la semana anterior a las visitas V2, V3, V4/retirada y cambio respecto al periodo basal
    - Cambios en los signos histológicos respecto al periodo basal (inflamación de la lámina propia, engrosamiento de la banda de colágeno subepitelial, número de LIE en el epitelio superficial, degeneración del epitelio superficial) en la visita V4/de retirada.
    - Tasa de remisión histológica conforme a la definición del apartado 6.4.7 en la visita V4/de retirada.
    - Tasa de mejoría/ausencia de cambios/empeoramiento a nivel histológico, definida conforme al apartado 6.4.7, en la visita V4/de retirada
    - Evaluación global por el médico (PGA) en la visita V4/de retirada
    - Dimensiones de la Escala abreviada de salud (SHS, Short Health Scale) de carga sintomática, función social, preocupación por la enfermedad y bienestar general en las visitas V2, V3, V4/retirada y cambio respecto al periodo basal

    Fase de seguimiento:
    - Tasa de pacientes respondedores al tratamiento que mantienen la remisión clínica en las entrevistas telefónicas de SEG1 y SEG2
    - Tasa de pacientes con recidiva en SEG1 y SEG2
    (definida como una media de ? 3 deposiciones/día y, de ellas, una media de ? 1 deposición líquida/día durante al menos una semana)
    - Tiempo hasta la recidiva
    E.5.2.1Timepoint(s) of evaluation of this end point
    Each visit, if not otherwise defined
    En cada visita, si no se define lo contrario
    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) 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 Yes
    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 Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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
    LVLS
    LVLS
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial 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: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 26
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 106
    F.4.2.2In the whole clinical trial 106
    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)
    Treatment after study end is left to investigator's discretion
    El tratamiento después del estudio se deja a criterio del investigador
    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 Decision2014-01-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-01-09
    P. End of Trial
    P.End of Trial StatusCompleted
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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