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    Summary
    EudraCT Number:2013-001248-67
    Sponsor's Protocol Code Number:LIN4113
    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:2013-11-12
    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 number2013-001248-67
    A.3Full title of the trial
    CLINICAL TRIAL PHASE IIIb to evaluate predictors of response to linaclotide in patients with irritable bowel syndrome and explore the impact on intestinal symptoms
    ENSAYO CLÍNICO FASE IIIb para evaluar factores predictores de respuesta a linaclotida en pacientes con Síndrome de Intestino Irritable y explorar el impacto sobre los síntomas extraintestinales
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of predictors of response to linaclotide in patients with irritable bowel syndrome and explore the impact on intestinal symptoms
    Evaluacion de factores predictores de respuesta a linaclotida en pacientes con Síndrome de Intestino Irritable y explorar el impacto sobre los síntomas extraintestinales
    A.3.2Name or abbreviated title of the trial where available
    linaclotide
    linaclotida
    A.4.1Sponsor's protocol code numberLIN4113
    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 Sponsoralmirall
    B.1.3.4CountrySpain
    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 supportAlmirall
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFib Hospital Clínico San Carlos
    B.5.2Functional name of contact pointUCICEC
    B.5.3 Address:
    B.5.3.1Street Addressprofesor Martín Lagos s/n
    B.5.3.2Town/ citymadrid
    B.5.3.3Post code28040
    B.5.3.4CountrySpain
    B.5.4Telephone number+349133030003793
    B.5.5Fax number+349133030003515
    B.5.6E-mailfibucicec.hcsc@salud.madrid.org
    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 Constella
    D.2.1.1.2Name of the Marketing Authorisation holderalmirall sa
    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 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 INNlinaclotide
    D.3.9.1CAS number 851199-59-2
    D.3.9.4EV Substance CodeSUB32529
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number290
    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
    Irritable bowel syndrome
    Síndrome de intestino irritable
    E.1.1.1Medical condition in easily understood language
    Irritable bowel syndrome
    Sindrome de intestino irritable
    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 16.1
    E.1.2Level PT
    E.1.2Classification code 10023003
    E.1.2Term Irritable bowel syndrome
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluate possible predictors of response to linaclotide, specifically the prevalence of pain on the altered bowel (proportion pain / constipation), which can allow the identification of profiles of IBS patients who would benefit from treatment
    Evaluar posibles factores predictores de respuesta a linaclotida, específicamente el predominio de dolor sobre la alteración del tránsito intestinal (proporción dolor/estreñimiento), que puedan permitir la identificación de los perfiles de pacientes con SII que más se beneficiarían del tratamiento
    E.2.2Secondary objectives of the trial
    asses whether the response at 4 weeks predicts response at 12 weeks
    Evaluate the impact of linaclotide on non-intestinal symptoms, digestive and non-digestive, associated with IBS.
    Evaluar si la respuesta a las 4 semanas predice la respuesta a las 12 semanas.
    Evaluar el impacto de linaclotida sobre los síntomas no intestinales, digestivos y no digestivos, asociados al SII.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age betwen 18 and 70 years old
    2. Sex: male and female
    3. Meet the Rome III criteria for the diagnosis of constipation predominant IBS
    4. Moderate-severe constipation IBS, defined as a score greater than 175 points IBSSS
    5. Clinical explorations to support the diagnosis of IBS:
    a. All patients: blood in less than six months that shows no anemia
    b. Over 50 years: colonoscopy to the cecum without abnormalities explaining the symptoms in the last five years.
    6. Sign informed consent: Patients should give informed consent in writing and must be able to read and understand it.
    1. Edad: mayor de 18 e inferior a 70 años
    2. Sexo: ambos sexos
    3. Cumplir criterios de Roma III para el diagnóstico de SII con predominio estreñimiento
    4. SII estreñimiento moderado-grave, definido como una puntuación del IBSSS mayor a 175 puntos
    5. Exploraciones complementarias para soportar el diagnóstico de SII:
    a. Todos los pacientes: análisis de sangre en menos de 6 meses que no muestre anemia
    b. Mayores de 50 años: colonoscopia hasta ciego sin hallazgos que justifiquen los síntomas en los últimos 5 años.
    6. Firma del consentimiento informado escrito: Los pacientes deberán otorgar un consentimiento informado escrito y deberán ser capaces de leer y comprender el mismo.
    E.4Principal exclusion criteria
    1. Women of childbearing age who are unwilling or unable to use valids methods of contraception during the study period and up to 4 weeks after finishing.
    2. Women of childbearing age who use an invalid method of contraception.
    3. Pregnant or breast-feeding.
    4l. Women with a positive pregnancy test at the time of enrollment or prior to study drug administration.
    1. Las mujeres en edad fértil que no quieran o no puedan usar un método anticonceptivo aceptable durante todo el periodo del estudio y hasta 4 semanas después de finalizado el estudio.
    2. Mujeres en edad fértil que utilicen un método anticonceptivo prohibido.
    3. Mujeres embarazadas o en periodo de lactancia.
    4. Mujeres con un resultado positivo en el test de embarazo en el momento de la inclusión o antes de la administración del fármaco del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Clinical response at 12 weeks defined as a subjective improvement on a Likert scale of "Cataloging opinion of the answer" as better or much better compared to baseline and accompanied by a decrease IBSSS score above 30% of baseline or achieve a score below 75 points
    respuesta clínica a las 12 semanas definida como una mejoría subjetiva en una escala Likert de ?Catalogación subjetiva de la respuesta? como mejor o mucho mejor respecto a la situación basal y acompañado de una disminución de la puntuación del IBSSS superior al 30% de la basal o alcance una puntuación por debajo de 75 puntos
    E.5.1.1Timepoint(s) of evaluation of this end point
    baseline, week 4 and week 12
    al inicio, semana 4 y semana 12
    E.5.2Secondary end point(s)
    Anxiety-depresion Score,
    PHQ12 Score
    Non intestinal digestive symptoms Score fear / worry Score
    Confidence in the drug
    baseline severity (IBSSS)
    Score de ansiedad-depresión,
    Score PHQ12 (síntomas extradigestivos), Score de sintomas digestivos no intestinales, Score miedo/preocupación,
    Score de confianza en el fármaco,
    Gravedad basal (IBSSS)
    E.5.2.1Timepoint(s) of evaluation of this end point
    baseline, week 4 and weeek 12
    inicio, 4ª semana y 12ª semana
    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 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 trial1
    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 concerned8
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee 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
    LVLS
    ultima visita del ultimo paciente
    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 months8
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 108
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 12
    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 state120
    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 Decision2014-01-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-11-07
    P. End of Trial
    P.End of Trial StatusOngoing
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