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    The EU Clinical Trials Register currently displays   43973   clinical trials with a EudraCT protocol, of which   7311   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    EudraCT Number:2017-003770-14
    Sponsor's Protocol Code Number:3030-202-002
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2018-07-17
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2017-003770-14
    A.3Full title of the trial
    A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Evaluate the Safety and Efficacy of Eluxadoline in Pediatric Patients (Age 12 to 17 Years) with Irritable Bowel Syndrome with Diarrhea (IBS-D)
    Estudio en fase II, aleatorizado, doble ciego, controlado con placebo, de grupos paralelos y de búsqueda de dosis, para evaluar la eficacia y seguridad de eluxadolina en pacientes pediátricos (edades comprendidas entre los 12 y 17 años) con síndrome del intestino irritable con diarrea (SII-D).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate the Safety and Efficacy of Eluxadoline in Patients Age 12 to 17 Years with Irritable Bowel Syndrome with Diarrhea
    Estudio para evaluar la seguridad y eficacia de la eluxadolina en pacientes pediátricos (de 12 a 17 años de edad) con síndrome
    del intestino irritable con diarrhea
    A.4.1Sponsor's protocol code number3030-202-002
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/388/2017
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAllergan LTD
    B.1.3.4CountryUnited Kingdom
    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 supportAllergan Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAllergan Ltd
    B.5.2Functional name of contact pointAllergan Ltd EU Regulatory Dept
    B.5.3 Address:
    B.5.3.1Street AddressMarlow International Parkway
    B.5.3.2Town/ cityMarlow / Buckinghamshire
    B.5.3.3Post codeSL7 1YL
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44(0) 1628 494444
    B.5.5Fax number+44(0) 1628 494449
    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 No
    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 nameEluxadoline
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Yes
    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 INNEluxadoline
    D.3.9.1CAS number 864821-90-9
    D.3.9.3Other descriptive nameELUXADOLINE
    D.3.9.4EV Substance CodeSUB175259
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    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
    Irritable Bowel Syndrome with
    Diarrhea (IBS-D)
    Syndrome del intestino irritable con diarrea (SII-D)
    E.1.1.1Medical condition in easily understood language
    Abdominal pain / discomfort.
    Cramps, bloating , diarrhea and constipation.
    Dolor abdominal/molestias
    Calambres, hinchazón, diarrea y estreñimiento
    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 20.1
    E.1.2Level PT
    E.1.2Classification code 10023003
    E.1.2Term Irritable bowel syndrome
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10060845
    E.1.2Term Diarrhea predominant irritable bowel syndrome
    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
    - To explore the therapeutic effect of eluxadoline in treating IBS-D in pediatric patients 12-17 years of age.
    - To evaluate the pharmacokinetics (PK) of eluxadoline in pediatric patients with IBS-D.
    - To evaluate the safety and tolerability of eluxadoline in pediatric patients with IBS-D.
    -Explorar el efecto terapéutico de la eluxadolina en el tratamiento del SIID en pacientes pediátricos de 12 a 17 años de edad.
    -Evaluar la farmacocinética (FC) de la eluxadolina en pacientes pediátricos con SII-D.
    -Evaluar la seguridad y tolerabilidad de la eluxadolina en pacientes
    pediátricos con SII-D.
    E.2.2Secondary objectives of the trial
    The results of this dose-ranging study will allow the selection of an optimal dose(s) of eluxadoline to evaluate in the subsequent confirmatory efficacy study.
    Los resultados de este estudio de búsqueda de dosis permitirán la selección de la(s) dosis óptima(s) de eluxadolina que se evaluarán en el posterior estudio de eficacia confirmatorio.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    To be eligible to participate in the study, patients must meet the following criteria:
    1. Patient must provide written or verbal informed assent and the parent/guardian/LAR must provide written informed consent before the initiation of any study-specific procedures.
    2. Patient is a male or female outpatient, 12 to 17 years of age inclusive, at the time the patient provides assent for the study and parent/guardian/LAR has provided signed consent.
    3. Patient is able to read and understand the assessments in the eDiary.
    4. Female patients of childbearing potential must have a negative serum pregnancy test at Visit 1 (screening) and a negative urine pregnancy test at Visit 3 (randomization) prior to dosing.
    5. Female patients who have had their first menstrual period and are sexually active must agree to use a reliable form of contraception. Reliable contraception is defined as:
    a) Hormonal contraception (eg, oral contraceptive, contraceptive implant, or injectable hormonal contraceptive).
    b) Double-barrier method (eg, condom plus intrauterine device, diaphragm plus spermicide).
    6. Patient has a diagnosis of IBS-D as defined by the modified Rome IV child/adolescent criteria*: Must include all of the following:
    1. Abdominal pain at least 4 days per month over at least 2 months associated
    with one or more of the following:
    a. Related to defecation
    b. A change in frequency of stool
    c. A change in form (appearance) of stool
    2. After appropriate evaluation, the symptoms cannot be fully explained by another medical condition
    3. Patient has predominantly diarrheal stool symptoms defined as Bristol stool types 6 or 7 for >25% of bowel movements and Bristol stool types 1 or 2 for <25% of bowel movements that occur in the absence of laxatives
    *All criteria fulfilled for at least 2 months prior to Visit 1 (screening).
    7. Patient has been compliant with the eDiary by completing both the morning and evening assessments for at least 8 out of the 14 days immediately preceding Visit 3 (randomization).
    8. Patient has an average daytime abdominal pain score ≥2.0 over the 2 weeks prior to randomization.
    9. Patient has at least 1 daytime bowel movement with a consistency of Type 6 or Type 7 on the pediatric Bristol Stool Form Scale (p-BSFS) on at least 2 days per week during the 2 weeks prior to randomization that occurs in the absence of laxatives.
    10. Patient has no clinically significant findings on a physical examination, vital sign assessment, electrocardiogram (ECG), and clinical laboratory tests (clinical chemistry panel, liver biochemical tests, complete blood count, urine drug screen, urinalysis) after providing informed assent and after written consent is obtained, but before receiving the first dose of study treatment. (A central laboratory will be used to evaluate all urine [except urine pregnancy tests] and blood samples and will
    utilize reference ranges specific to a patient’s age and gender. ECGs will be performed and electronically transmitted to a central ECG laboratory for analysis by a pediatric cardiologist in accordance with the instructions provided by the central ECG laboratory. The Investigator will determine if a particular finding is clinically significant. [In making this determination, the Investigator will consider whether the particular finding could represent a condition that would exclude the patient from the study, could represent a safety concern if the patient participates in the study, or could confound the study-specific assessments of safety or efficacy.])
    Para ser elegibles para participar en el estudio, los pacientes deben satisfacer los siguientes criterios:
    1. El paciente debe dar el asentimiento informado por escrito o de palabra y el progenitor/tutor/representante legal debe proporcionar el consentimiento informado por escrito antes de iniciar cualquier procedimiento específico del estudio.
    2. En el momento en que el paciente da el asentimiento para el estudio y el progenitor/tutor/representante legal entrega el consentimiento firmado, el paciente es un paciente ambulatorio de sexo masculino o femenino de 12 a 17 años de edad (ambos incluidos).
    3. El paciente es capaz de leer y entender las evaluaciones en el cuaderno electrónico.
    4. Las mujeres en edad fértil deben disponer de una prueba de embarazo en sangre con resultado negativo en la visita 1 (selección) y una prueba de embarazo en orina con resultado negativo en la visita 3 (aleatorización), antes de la dosificación.
    5. Las mujeres que hayan tenido su primera menstruación y sean sexualmente activas deben acceder al uso de un método anticonceptivo fiable. El método anticonceptivo fiable se define como:
    a) Un anticonceptivo hormonal (p. ej., anticonceptivo oral, implante anticonceptivo o anticonceptivo hormonal inyectable).
    b) Método de doble barrera (p. ej., condón más dispositivo intrauterino, diafragma más espermicida).
    6. Se ha diagnosticado al paciente SII-D, tal y como se define en los criterios modificados de Roma IV para niños/adolescentes;* debe satisfacer todos los siguientes:
    1. Dolor abdominal al menos 4 días al mes durante al menos 2 meses asociado a uno o más de los siguientes puntos:
    a. Relacionado con la defecación
    b. Un cambio en la frecuencia de las defecaciones
    c. Un cambio en la forma (apariencia) de las heces
    2. Tras una evaluación apropiada, ninguna otra enfermedad explica por complete los síntomas.
    3. El paciente presenta predominantemente síntomas de heces diarreicas definidos como tipos 6 o 7 en la escala de heces de Bristol en >25 % de las deposiciones y tipos 1 o 2 en la escala de Bristol en <25 % de las deposiciones sin haber tomado laxantes.
    *Todos los criterios deben haberse satisfecho durante al menos 2 meses antes de la visita 1 (selección).
    7. El paciente ha cumplido el criterio del cuaderno electrónico, puesto que ha completado las evaluaciones matutinas y vespertinas durante al menos 8 de los 14 días inmediatamente anteriores a la visita 3 (aleatorización).
    8. El paciente tiene una puntuación media de dolor abdominal diurno de ≥2,0 durante las 2 semanas previas a la aleatorización.
    9. El paciente realiza al menos 1 defecación durante el horario diurno con una consistencia de tipo 6 o 7 en la escala de heces de Bristol para pacientes pediátricos (p-BSFS, por sus siglas en inglés) por lo menos 2 días a la semana durante las 2 semanas previas a la aleatorización sin haber tomado laxantes.
    10. El paciente no presenta signos clínicamente significativos en una exploración física, una evaluación de las constantes vitales, un electrocardiograma (ECG) y análisis clínicos (bioquímica clínica, pruebas bioquímicas hepáticas, hemograma completo, análisis farmacológico de orina, análisis de orina) después de dar el asentamiento informado y tras obtener el consentimiento por escrito, pero antes de recibir la primera dosis del tratamiento del estudio. (Se empleará un laboratorio central para evaluar todas las muestras de orina [excepto las pruebas de embarazo en orina] y de sangre, y se aplicarán intervalos de referencia específicos para la edad y el sexo del paciente. Los ECG se realizarán y se transferirán electrónicamente a un laboratorio central de ECG para que un cardiólogo pediátrico los analice conforme a las instrucciones proporcionadas por el laboratorio central de ECG. El investigador determinará si un hallazgo concreto es clínicamente significativo. [Para tomar esta determinación, el investigador tendrá en cuenta si el hallazgo concreto puede representar una enfermedad que excluya al paciente del estudio o un riesgo de seguridad si el paciente participa en el estudio, o bien si puede entorpecer las evaluaciones de seguridad o eficacia específicas del estudio.])
    E.4Principal exclusion criteria
    Patients who meet any of the following criteria will not be eligible to participate in the study:
    1.has no gallbladder
    2.has had any of the following surgeries:
    a)Any abdominal surgery within the 3 months prior to trial;
    b)A history of major gastric, hepatic, pancreatic, or intestinal surgery
    3.has known or suspected biliary duct obstruction, or sphincter of Oddi disease or dysfunction
    4.has a history of pancreatitis; structural diseases of the pancreas, known or
    suspected pancreatic duct obstruction
    5.has a history of cholecystitis within 6months before trial.
    6.has known or suspected bile acid malabsorption.
    7.is a current regular alcohol drinker and/or binge drinker, and/or has a history
    of alcoholism, alcohol abuse, or alcohol addiction, and/or intends to consume alcohol during the trial.
    8.has had chronic or severe constipation or sequelae from constipation,
    or known or suspected mechanical GI obstruction or pseudo obstruction.
    9.has had or current diagnosis of constipation with encopresis.
    10.meets the child/adolescent Rome IV criteria of IBS with constipation, IBS
    with constipation and diarrhea (mixed), unspecified IBS, or functional constipation.
    11.has had intestinal obstruction, stricture, toxic megacolon, GI perforation, fecal impaction, gastric banding, bariatric surgery, adhesions, ischemic colitis, or impaired intestinal circulation.
    12.has a history of hepatic impairment as defined by Child-Pugh Classification Grade A,B or C
    13.has a history or current diagnosis of inflammatory or immune-mediated lower
    GI disorders including inflammatory bowel disease
    14.has celiac disease,or a positive serological test for celiac disease and the
    condition has not been ruled out by endoscopic biopsy
    15.has any congenital and/or acquired malabsorption syndrome
    16.has a history of a microbiologically documented GI infection within 3months prior to trial
    17.has a known lactose or fructose intolerance
    18.has a history of diverticulitis within 3 months prior to trial
    19.has had within 5 years prior to trial or current evidence of laxative abuse
    20.has a history of either hypo-or hyperthyroidism that is untreated or treated
    with medication at a dose that has not been stable for at least 3months prior to
    21.Patient’s diarrhea is deemed by the Investigator to be caused by infectious
    22.has had or current evidence of blood in the stool
    23.currently has both unexplained and clinically significant alarm symptoms and systemic signs of infection or colitis, or any neoplastic process
    24.has a history or current diagnosis of eosinophilic gastroenteritis
    25.has Cystic Fibrosis, and or any other causes of pancreatic exocrine insufficiency
    26.is receiving enteral tube feeding
    27.has a history of a cardiovascular event, including stroke, myocardial infarction, congestive heart failure, or transient ischemic attack within 6months prior to trial
    28.has an unstable renal, hepatic, metabolic, or hematologic condition
    29.has a history of malignancy within 5 years before Screening, which includes any new diagnosis of malignancy or any treatment for or recurrence of a malignancy that was diagnosed 5 or more years prior. In order to be eligible for the study, patient must be malignancy free for the past 5years
    30.has a history of immunodeficiency
    31.has a history of drug abuse
    32.has a positive urine drug result
    33.has a weight and BMI less than the 3rd percentile.
    34.has had an unintentional weight loss greater than or equal to 5% of his/her
    body weight within the last 3months
    35.Female patients who are pregnant or nursing, or plan to become pregnant or nurse during the trial
    36.has known allergies or hypersensitivity to opioids
    37.used a prohibited medication or failed to meet the stabledose
    38.is unable to tolerate the placebo oral tablets prior to randomization.
    39.has any condition that, in the opinion of the Investigator, would contribute to
    the patient’s IBS-D symptoms or confound the evaluation of safety or efficacy of the IMP
    40.has neurodevelopmental disabilities producing a cognitive delay that precludes comprehension and completion of the daily eDiary or other study-related questionnaires
    41.has a poorly treated or poorly controlled psychiatric disorder that might
    influence the patient’s ability to participate in the study
    42.has an acute or chronic condition that, in the Investigator's opinion, would
    limit the patients' ability to complete or participate in this clinical study
    43.has any condition that, in the opinion of the Investigator, would compromise
    the well-being of the patient
    44.received an investigational product during the 30 days before Visit1 or is planning to receive an IMP or use an investigational device at any time during the
    45. Patient’s parent/guardian/LAR has been directly or indirectly involved in the conduct and administration of this study as an Investigator, Sub-Investigator, Study Coordinator, or other study member
    Los pacientes que satisfagan alguno de los siguientes criterios no serán elegibles para participar en el estudio:
    1. El paciente no tiene vesícula biliar
    2. El paciente se ha sometido alguna de las siguientes intervenciones quirúrgicas:
    a) cualquier intervención quirúrgica abdominal durante los 3 meses anteriores a la selección; o bien
    b) antecedentes de cirugía mayor gástrica, hepática, pancreática o intestinal.
    3. El paciente presenta una obstrucción o sospecha de obstrucción del conducto biliar, o bien disfunción del esfínter de Oddi.
    4. El paciente tiene antecedentes de pancreatitis; alteraciones estructurales del páncreas, obstrucción o sospecha de obstrucción del conducto pancreático.
    5. El paciente tiene antecedentes de colecistitis durante los 6 meses anteriores a la selección.
    6. El paciente presenta malabsorción de ácido biliar o sospecha de la misma.
    7. El paciente bebe alcohol regularmente y/o presenta episodios de consumo intensivo de alcohol, y/o tiene antecedentes de alcoholismo, abuso de bebidas alcohólicas o adicción al alcohol, y/o tiene la intención de consumir alcohol durante el ensayo.
    8. El paciente tiene antecedentes de estreñimiento crónico o grave o secuelas de estreñimiento, o bien oclusión intestinal mecánica o seudooclusión o sospecha de esta.
    9. El paciente tiene antecedentes o diagnóstico actual de estreñimiento con encopresis.
    10. El paciente satisface los criterios de Roma IV para niños/adolescentes de SII con estreñimiento, SII con estreñimiento y diarrea (mixto), SII no especificado o estreñimiento functional.
    11. El paciente tiene antecedentes de oclusión intestinal, estenosis intestinal, megacolon tóxico, perforación gastrointestinal, retención fecal, cerclaje gástrico, cirugía bariátrica, adherencias, colitis isquémica o trastorno de circulación intestinal.
    12. El paciente tiene antecedentes registrados de disfunción hepática tal y como está definida en los grados A, B y C de la escala de Child-Pugh
    13. El paciente tiene antecedentes o diagnóstico actual de trastornos digestivos bajos de origen inflamatorio o inmunitario, incluida la enfermedad intestinal inflamatoria
    14. El paciente presenta celiaquía o bien una prueba serológica con resultado positive para celiaquía y no se ha descartado la enfermedad mediante biopsia endoscópica.
    15. El paciente tiene algún síndrome de malabsorción congénito y/o adquirido
    16. El paciente tiene antecedentes de infección gastrointestinal con confirmación microbiológica (es decir, cultivo de heces o antecedentes médicos) durante los 3 meses anteriores a la selección.
    17. El paciente presenta una intolerancia conocida a la lactosa o fructosa
    18. El paciente tiene antecedentes de diverticulitis durante los 3 meses previos a la selección.
    19. El paciente tiene antecedentes durante los 5 años anteriores a la selección o indicios actuales de abuso de laxantes.
    20. El paciente tiene antecedentes de hipotiroidismo o hipertiroidismo que no ha sido tratado o ha sido tratado con medicamentos a una dosis que no ha sido estable durante al menos los 3 meses previos a la selección.
    21. El investigador considera que la diarrea del paciente está causada por una infección
    22. El paciente tiene antecedentes o indicios actuales de sangre en las heces
    23. El paciente presenta actualmente síntomas de alarma de causa desconocida y clínicamente significativos
    24. El paciente tiene antecedentes o diagnóstico actual de gastroenteritis eosinofílica.
    25. El paciente presenta fibrosis quística y/o cualquier otra causa de insuficiencia pancreática exocrina.
    26. El paciente está recibiendo nutrición enteral.
    27. El paciente tiene antecedentes de episodios cardiovasculares, incluida apoplejía, infarto de miocardio, insuficiencia cardíaca congestiva o accidente isquémico transitorio durante los 6 meses anteriores a la selección.
    28. El paciente presenta una alteración renal, hepática, metabólica o hematológica inestable.
    29. El paciente tiene antecedentes de neoplasia maligna (excepto carcinomas basocelulares o epidermoides y carcinoma de cuello uterino in situ) durante los 5 años anteriores a la selección,
    30. El paciente tiene antecedentes de inmunodeficiencia (p. ej., infección por VIH, deficiencia de IgA o IgG).
    31. El paciente tiene antecedentes de drogadicción.
    32. El paciente ha obtenido un resultado positivo en el análisis de orina para cocaína, barbitúricos o canabinoides.
    33. El paciente tiene un peso y un índice de masa corporal (IMC) inferior al percentil 3.
    34. El paciente ha experimentado una pérdida de peso involuntaria superior o igual al 5 % de su peso corporal en los últimos 3 meses.
    35. Mujeres que actualmente están embarazadas o son lactantes, o que prevén quedarse embarazadas o lactar durante el estudio clínico.
    Para el resto de criterio consulte el protocolo
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy assessment will be the change from baseline in the 24‑
    hour (combined daytime and nighttime) stool consistency averaged over the
    4-week Treatment Period.
    El principal criterio de valoración de la eficacia será el cambio con respecto al valor basal en la consistencia de las heces de 24 horas (englobando horario diurno y nocturno) promediado durante el periodo de tratamiento de 4 semanas.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Throughout the study
    Over the 4-week period
    A lo largo del studio
    Durante el periodo de 4 semanas
    E.5.2Secondary end point(s)
    The secondary efficacy parameters include change from baseline in the
    4-week average for daily daytime and nighttime stool consistency scores
    during the Treatment Period, as well as change from baseline in the 4-week
    average for daytime, nighttime, and 24-hour (combined daytime and nighttime) abdominal pain, bowel movement frequency, urgency-free days in a week, and number of fecal incontinence-free days in a week during the Treatment Period.

    The secondary change-from-baseline efficacy parameters will be analyzed in a
    similar way as the primary efficacy parameter using the ANCOVA model.
    Los parámetros secundarios de eficacia incluyen el cambio desde el valor basal de los índices diarios de consistencia de las heces diurnas y nocturnas promediado durante las 4 semanas del periodo de tratamiento, así como el cambio desde el valor basal del dolor abdominal diurno, nocturno y de 24 horas (englobando diurno y nocturno), la frecuencia de defecación, los días sin urgencia en una semana y el número de días sin incontinencia fecal en una semana promediado durante las 4 semanas del periodo de tratamiento.
    Los parámetros de eficacia secundarios de cambio desde el valor basal se analizarán de forma similar al parámetro principal de eficacia utilizando el modelo ANCOVA.
    E.5.2.1Timepoint(s) of evaluation of this end point
    throughout the study
    4 week
    A lo largo del studio
    4 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 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. trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    E. trial design description
    Rango de dosis
    Dose Ranging
    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 trial4
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA66
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    United Kingdom
    United States
    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
    The end of Trial is defined by the Last Patient Last visit
    El final del tratamiento está definido como el ultimo paciente última visita
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months9
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 120
    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) Yes
    F. of subjects for this age range: 120
    F.1.2Adults (18-64 years) No
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 70
    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)
    No treatment will be given to the patients after the study has ended
    No se proporcionará nungún tratamiento a los pacientes después de que finalice el estudio
    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 Decision2018-09-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-07-30
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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