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    Summary
    EudraCT Number:2016-003827-45
    Sponsor's Protocol Code Number:MA39293-DIET
    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:2017-11-22
    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 number2016-003827-45
    A.3Full title of the trial
    AN OPEN LABEL PHASE IV, MULTICENTER, INTERNATIONAL, INTERVENTIONAL STUDY TO EVALUATE THE EFFECT OF DIET ON GASTROINTESTINAL ADVERSE EVENTS IN PATIENTS WITH IPF TREATED WITH PIRFENIDONE
    ESTUDIO INTERNACIONAL DE MINIMA INTERVENCIÓN EN FASE IV, MULTICÉNTRICO Y ABIERTO, PARA EVALUAR EL EFECTO DE LA DIETA SOBRE LOS EFECTOS ADVERSOS GASTROINTESTINALES EN PACIENTES CON FPI TRATADOS CON PIRFENIDONA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    AN OPEN LABEL PHASE IV, MULTICENTER, INTERNATIONAL, INTERVENTIONAL STUDY TO EVALUATE THE EFFECT OF DIET ON GASTROINTESTINAL ADVERSE EVENTS IN PATIENTS WITH IPF TREATED WITH PIRFENIDONE
    ESTUDIO INTERNACIONAL DE MINIMA INTERVENCIÓN EN FASE IV, MULTICÉNTRICO Y ABIERTO, PARA EVALUAR EL EFECTO DE LA DIETA SOBRE LOS EFECTOS ADVERSOS GASTROINTESTINALES EN PACIENTES CON FPI TRATADOS CON PIRFENIDONA
    A.3.2Name or abbreviated title of the trial where available
    MADIET
    MADIET
    A.4.1Sponsor's protocol code numberMA39293-DIET
    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 SponsorCIBER - Instituto Carlos III
    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 supportHoffmann-La Roche
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationALPHA BIORESEARCH- NEXT CRO MONEPE, UNIÓN TEMPORAL DE EMPRESAS, LEY 18/82
    B.5.2Functional name of contact pointAlicia Navarro Cid
    B.5.3 Address:
    B.5.3.1Street AddressPso. de la Castellana, 163. 2º Izq
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28046
    B.5.3.4CountrySpain
    B.5.4Telephone number34917452520
    B.5.5Fax number34917450653
    B.5.6E-mailalicia.navarro@alphabioresearch.com
    B.Sponsor: 2
    B.1.1Name of SponsorInstitut d'Investigació Biomédica de Bellvitge (IDIBELL)
    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 supportHoffmann-La Roche
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationALPHA BIORESEARCH- NEXT CRO MONEPE, UNIÓN TEMPORAL DE EMPRESAS, LEY 18/82
    B.5.2Functional name of contact pointAlicia Navarro Cid
    B.5.3 Address:
    B.5.3.1Street AddressPso. de la Castellana, 163 2ºIzq
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28046
    B.5.3.4CountrySpain
    B.5.4Telephone number34917452520
    B.5.5Fax number34917450653
    B.5.6E-mailalicia.navarro@alphabioresearch.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 ESBRIET
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/04/241
    D.3 Description of the IMP
    D.3.1Product nameESBRIET
    D.3.4Pharmaceutical form Capsule, hard
    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 INNPIRFENIDONE
    D.3.9.1CAS number 53179-13-8
    D.3.9.2Current sponsor codeESBRIET
    D.3.9.3Other descriptive nameESBRIET
    D.3.9.4EV Substance CodeSUB09907MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number801
    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.IMP: 2
    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 ESBRIET
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/04/241
    D.3 Description of the IMP
    D.3.1Product nameESBRIET
    D.3.4Pharmaceutical form Capsule, hard
    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 INNPIRFENIDONE
    D.3.9.1CAS number 53179-13-8
    D.3.9.2Current sponsor codeESBRIET
    D.3.9.3Other descriptive nameESBRIET
    D.3.9.4EV Substance CodeSUB09907MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1602
    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.IMP: 3
    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 ESBRIET
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/04/241
    D.3 Description of the IMP
    D.3.1Product nameESBRIET
    D.3.4Pharmaceutical form Capsule, hard
    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 INNPIRFENIDONE
    D.3.9.1CAS number 53179-13-8
    D.3.9.2Current sponsor codeESBRIET
    D.3.9.3Other descriptive nameESBRIET
    D.3.9.4EV Substance CodeSUB09907MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2403
    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
    Idiopathic Pulmonary Fibrosis
    Fibrosis Pulmonar Idiopática
    E.1.1.1Medical condition in easily understood language
    Idiopathic Pulmonary Fibrosis
    Fibrosis Pulmonar Idiopática
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10021240
    E.1.2Term Idiopathic pulmonary fibrosis
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To compare the incidence of gastrointestinal AEs in patients treated with IPF, initiating pirfenidone for the first time, according to the type of diet (MUFA vs SFA). Gastrointestinal AEs rates between study groups will be evaluated during the first 16 weeks of pirfenidone treatment.
    Any gastrointestinal AE related to pirfenidone treatment, including nausea, diarrhea, dyspepsia, reflux, vomiting, stomach discomfort, and abdominal distension, will be studied.
    • Comparar la incidencia de AA gastrointestinales en pacientes con FPI en tratamiento, que inician el tratamiento con pirfenidona por primera vez, de acuerdo con el tipo de dieta (AGMI frente a AGS). Se evaluarán las tasas de AA gastrointestinales entre los grupos del estudio durante las primeras 16 semanas de tratamiento con pirfenidona.
    Se estudiarán todos los AA gastrointestinales relacionados con el tratamiento con pirfenidona, incluyendo náuseas, diarrea, dispepsia, reflujo, vómitos, molestias estomacales y distensión abdominal.
    E.2.2Secondary objectives of the trial
    • To evaluate the characteristics of the patients in both arms, including associated epidemiological parameters
    • Severity (according to the Common Terminology Criteria {CTC} grading for Adverse Events version 4.0), frequency, duration of the gastrointestinal side effects, discontinuation of treatment, dose reduction and hospitalization due to these side effects.
    • Specific variables of the diet that may interfere in gastric treatment-emergent side effects:
    o Number of daily meals
    o Method of cooking the food
    o Use of butter/oil in cooking
    o Quantity and variety of foods
    • Other factors that may act on gastric function and drug absorption: weight, use of proton pump inhibitors (PPI), gastro-prokinetics (such as Cisapride, Domperidone, and Metoclopromide)
    • Evaluar las características de los pacientes de ambos grupos, incluidos los parámetros epidemiológicos asociados
    • Intensidad (de acuerdo con la clasificación de los Criterios Terminológicos Comunes {CTC} de acontecimientos adversos versión 4.0), frecuencia, duración de los efectos secundarios gastrointestinales, interrupción del tratamiento, reducción de la dosis y hospitalización debido a estos efectos secundarios.
    • Variables específicas de la dieta que pueden interferir en los efectos secundarios gástricos surgidos durante el tratamiento:
    o Número de comidas al día
    o Método de cocción de los alimentos
    o Uso de mantequilla/aceite en la cocción
    o Cantidad y variedad de alimentos
    • Otros factores que pueden actuar sobre la función gástrica y la absorción del fármaco: peso, uso de inhibidores de la bomba de protones (IBP), gastroprocinéticos (como cisaprida, domperidona y metoclopramida)
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Sub-study to evaluate the pharmacokinetics of pirfenidone according to type of diet in patients with idiopathic pulmonary fibrosis.
    Sub estudio para evaluar la farmacocinética de pirfenidona según el tipo de dieta en pacientes con fibrosis pulmonar idiopática.
    E.3Principal inclusion criteria
    • Signed Informed Consent Form
    • Ability to comply with the study protocol in the opinion of the Investigator
    • Age > 40 years
    • Diagnosis of IPF at least 1 week prior to study baseline and no more than 5 years.
    • Confirmation of IPF diagnosis by the Investigator of each Centre, in accordance with the 2011 international consensus guidelines (Raghu et al. 2011), at baseline.
    • IPF that meet criteria for pirfenidone treatment initiation according to local reimbursement policy
    • Approval of potential study participation by Central Committee (FFQ shows a clear diet predominance, MUFA or SFA).
    Defined and regular diet for at least six months prior to baseline (i.e. no frequent changes in the type of diet).
    • For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of <1% per year during the Treatment Period and for at least 58 days after the last dose of study treatment
    o A woman is considered to be of childbearing potential if she is post-menarcheal, has not reached a post-menopausal state (≥12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus).
    o Examples of contraceptive methods with a failure rate of <1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.
    o The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.
    • For men who are not surgically sterile: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as defined below:
    o With female partners of childbearing potential, men must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of <1% per year during the Treatment Period and for at least 118 days after the last dose of trial treatment to avoid exposing the embryo. Men must refrain from donating sperm during this same period.
    • Formulario de consentimiento informado firmado
    • Capacidad para cumplir el protocolo de estudio según la opinión del investigador
    • Edad > 40 años
    • Diagnóstico de FPI al menos 1 semana y no más de 5 años antes del inicio del estudio.
    • Confirmación del diagnóstico de FPI por el investigador de cada centro, de acuerdo con las directrices de consenso internacional de 2011 (Raghu et al. 2011), al inicio.
    • Que la FPI cumple los criterios para el inicio de tratamiento con pirfenidona de acuerdo con la política de reembolso local
    • Aprobación de la participación potencial en el estudio por parte del Comité Central (el CFCA muestra una predominancia clara en la dieta, AGMI o AGS).
    Dieta definida y regular durante al menos seis meses antes del inicio (es decir, sin cambios frecuentes en el tipo de dieta).
    • En el caso de mujeres en edad fértil: acuerdo de no mantener relaciones sexuales (abstenerse de mantener relaciones heterosexuales) o utilizar un método anticonceptivo con una tasa de fracaso <1 % al año durante el período de tratamiento y durante al menos 58 días después de la última dosis del tratamiento en estudio
    o Se considera que una mujer está en edad fértil si es posmenárquica, si no ha llegado a la menopausia (≥12 meses seguidos de amenorrea sin una causa identificada distinta de la menopausia), y si no se ha sometido a esterilización quirúrgica (extirpación de ovarios y/o útero).
    o Algunos ejemplos de métodos anticonceptivos con una tasa de fracaso <1 % al año incluyen la ligadura de trompas bilateral, la esterilización masculina, los anticonceptivos hormonales que inhiben la ovulación, los dispositivos intrauterinos liberadores de hormonas y los dispositivos intrauterinos de cobre.
    o La fiabilidad de la abstinencia sexual debe evaluarse en función de la duración del ensayo clínico y del estilo de vida preferido y habitual de la paciente. La abstinencia periódica (p. ej., calendario, ovulación, sintotérmica o métodos posovulación) y la marcha atrás no son métodos anticonceptivos aceptables.
    • En el caso de hombres que no se han sometido a esterilización quirúrgica: acuerdo de no mantener relaciones sexuales (abstenerse de mantener relaciones heterosexuales) o utilizar métodos anticonceptivos, acuerdo de abstenerse de realizar donaciones de esperma, según se define a continuación:
    o Con parejas femeninas en edad fértil, el hombre debe abstenerse de mantener relaciones sexuales o bien utilizar un preservativo junto con un método anticonceptivo adicional para, en conjunto, alcanzar una tasa de fracaso <1 % al año durante el período de tratamiento y durante al menos 118 días después de la última dosis del tratamiento del ensayo para evitar la exposición del embrión. Los hombres deben abstenerse de realizar donaciones de esperma durante dicho período.
    E.4Principal exclusion criteria
    • History of coexistent and clinically significant (in the opinion of the Investigator) COPD (including chronic bronchitis, emphysema), bronchiectasis, asthma, inadequately treated sleep-disordered breathing, or any clinically significant pulmonary diseases or disorders other than IPF.
    • History of any connective tissue disease, including, but not limited to: rheumatoid arthritis, scleroderma, polymyositis/dermatomyositis, systemic lupus erythematosus, or mixed connective tissue disease
    • History of clinically significant environmental exposure to agents known to cause pulmonary fibrosis, including asbestos, beryllium, silica, and other occupational dusts; amiodarone, nitrofurantoin, and other drugs; radiation; and birds, feathers, molds, and other inhaled antigens known to cause hypersensitivity pneumonitis
    • Participation in any other investigational trial throughout the study
    • Any serious medical condition that, in the opinion of the Investigator, may pose an additional risk in administering study treatment to the patient
    • Certain laboratory abnormalities or findings at baseline, including:
    o Total bilirubin > 5 of the upper limit of normal (ULN)
    o AST/SGOT or ALT/SGPT >1.5 ULN
    o Alkaline phosphatase >2.0 ULN
    o Creatinine clearance <40 mL/min, calculated using the Cockcroft-Gault formula
    • Pregnant or lactating, or intending to become pregnant during the study
    • Pharmacological treatments (concomitant-therapy) at baseline that may cause patient gastrointestinal side effects
    • Major gastro-intestinal disorders at baseline (gastric or bowel surgery, ulcus). Patients with gastroesophagic reflux or other minor digestive disorders can be included.
    • Pregnant patients, or women of child-bearing potential, not using a reliable contraceptive method
    • Planning to change the type of diet in the next 4 months
    • Not able to follow a specific type of diet or cannot be allocated to a specific type of diet (MUFA vs SFA) by the Central Committee
    • Previous intolerance or allergy to pirfenidone or hypersensitivity to the active substance or to any of the excipients
    • Antecedentes de EPOC (incluyendo bronquitis crónica, enfisema) coexistente y clínicamente significativa (según la opinión del investigador), bronquiectasia, asma, tratamiento inadecuado de la apnea del sueño, o cualquier enfermedad pulmonar clínicamente significativa o trastornos diferentes de la FPI.
    • Antecedentes de cualquier enfermedad del tejido conjuntivo, incluyendo, entre otros: artritis reumatoide, esclerodermia, polimiositis/dermatomiositis, lupus eritematoso sistémico o enfermedad mixta del tejido conjuntivo
    • Antecedentes de exposición ambiental clínicamente significativa a agentes que se sabe que causan fibrosis pulmonar, incluyendo amianto, berilio, sílice y otras sustancias en polvo en el lugar de trabajo; amiodarona, nitrofurantoína y otros fármacos; radiación; y pájaros, plumas, moho y otros antígenos inhalados que se sabe que causan neumonitis por hipersensibilidad
    • Historia de colitis y otras enfermedades inflamatorias intestinales
    • Participación en otro ensayo de investigación durante el estudio
    • Cualquier estado médico grave que, en la opinión del investigador, pueda suponer un riesgo adicional al administrar el tratamiento en estudio al paciente
    • Determinadas pruebas analíticas anómalas al inicio, incluyendo:
    o Bilirrubina total >5 del límite superior de la normalidad (LSN)
    o AST/SGOT o ALT/SGPT >1,5 LSN
    o Fosfatasa alcalina >2,0 LSN
    o Aclaramiento de creatinina <40 ml/min, calculado con la fórmula de Cockcroft-Gault
    • Mujeres embarazadas o en período de lactancia, o que intentan quedarse embarazadas durante el estudio
    • Tratamientos farmacológicos (terapia concomitante) al inicio que pueden causar efectos secundarios gastrointestinales al paciente
    • Trastornos gastrointestinales importantes al inicio (cirugía gástrica o intestinal, úlcera). Pueden incluirse pacientes con reflujo gastroesofágico u otros trastornos digestivos leves.
    • Mujeres embarazadas o en edad fértil, que no utilizan un método anticonceptivo fiable
    • Pacientes que planean cambiar el tipo de dieta en los próximos 4 meses
    • Pacientes que no pueden seguir un tipo de dieta específica o que el Comité Central no puede asignar a un tipo de dieta específica (AGMI frente a AGS)
    • Intolerancia previa o alergia a la pirfenidona o hipersensibilidad al principio activo o a cualquiera de los excipientes
    E.5 End points
    E.5.1Primary end point(s)
    • To compare the incidence of gastrointestinal AEs in patients treated with IPF, initiating pirfenidone for the first time, according to the type of diet (MUFA vs SFA). Gastrointestinal AEs rates between study groups will be evaluated during the first 16 weeks of pirfenidone treatment.
    Any gastrointestinal AE related to pirfenidone treatment, including nausea, diarrhea, dyspepsia, reflux, vomiting, stomach discomfort, and abdominal distension, will be studied.
    • Comparar la incidencia de AA gastrointestinales en pacientes con FPI en tratamiento, que inician el tratamiento con pirfenidona por primera vez, de acuerdo con el tipo de dieta (AGMI frente a AGS). Se evaluarán las tasas de AA gastrointestinales entre los grupos del estudio durante las primeras 16 semanas de tratamiento con pirfenidona.
    Se estudiarán todos los AA gastrointestinales relacionados con el tratamiento con pirfenidona, incluyendo náuseas, diarrea, dispepsia, reflujo, vómitos, molestias estomacales y distensión abdominal.
    E.5.1.1Timepoint(s) of evaluation of this end point
    16 weeks
    16 semanas
    E.5.2Secondary end point(s)
    Baseline characteristics of MUFA and SFA subjects will be described and evaluated using mean and standard deviation for continuous symmetric variables, median and interquartile range (Q1-Q3) for non-symmetric variables and absolute and relative frequencies for categorical variables.
    Las características iniciales de los sujetos de los grupos de AGMI y AGS se describirán y evaluarán utilizando la media y la desviación estándar de variables simétricas continuas, la mediana y el intervalo intercuartílico (Q1-Q3) de las variables asimétricas, y las frecuencias absoluta y relativa para las variables categóricas.
    E.5.2.1Timepoint(s) of evaluation of this end point
    16 weeks
    16 semanas
    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 No
    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 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 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 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 concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA6
    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
    Última visita del último 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 months18
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months18
    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: 45
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 45
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 90
    F.4.2.2In the whole clinical trial 90
    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 Decision2017-12-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-12-14
    P. End of Trial
    P.End of Trial StatusOngoing
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