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    Summary
    EudraCT Number:2013-000821-30
    Sponsor's Protocol Code Number:SAD13-ER1
    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:2013-06-10
    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 number2013-000821-30
    A.3Full title of the trial
    CLINICAL RESPONSE TO 5HT4 RECEPTORS AGONIST (PRUCALOPRIDE): GASTROCOLIC REFLEX
    ESTUDIO DEL REFLEJO GASTROCOLICO: INFLUENCIA DE PRUCALOPRIDA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    CLINICAL RESPONSE TO 5HT4 RECEPTORS AGONIST (PRUCALOPRIDE): GASTROCOLIC REFLEX
    ESTUDIO DEL REFLEJO GASTROCOLICO: INFLUENCIA DE PRUCALOPRIDA
    A.3.2Name or abbreviated title of the trial where available
    GASTROCOLIC REFLEX
    reflejo gastrocolico
    A.4.1Sponsor's protocol code numberSAD13-ER1
    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 SponsorEnrique Rey Díaz-Rubio
    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 supportfundacion investigación biomedica hospital clinico san carlos
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationfundacion investigación biomedica hospital clinico san carlos
    B.5.2Functional name of contact pointana belen rivas paterna
    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 number00349133030003793
    B.5.5Fax number00349133030003515
    B.5.6E-mailfibucicec.hcsc@salud.madrid.org
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 Resolor
    D.2.1.1.2Name of the Marketing Authorisation holderShire Pharmaceuticals Ibérica, S.L
    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 Tablet
    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 INNPRUCALOPRIDE SUCCINATE
    D.3.9.3Other descriptive namePRUCALOPRIDE SUCCINATE
    D.3.9.4EV Substance CodeSUB28850
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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
    chronic constipation
    estreñimiento cronico
    E.1.1.1Medical condition in easily understood language
    chronic constipation
    estreñimiento cronico
    E.1.1.2Therapeutic area Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess whether 5HT4 agonist (prucalopride at a dose of 2 mg/day) increases the gastrocolic reflex in patients with chronic constipation.
    Evaluar si la prucaloprida (dosis de 2 mg) induce un mayor aumento del tono rectal postprandial que en condiciones fisiológicas.
    E.2.2Secondary objectives of the trial
    - To assess whether there is a relationship between the magnitude of increased CCK levels and that of the gastrocolic reflex under physiological conditions in patients with chronic constipation.
    - To assess whether there is a temporal relationship between CCK levels and the duration of the gastrocolic reflex under physiological conditions in patients with chronic constipation.
    - To assess whether 5HT4 agonist (prucalopride 2 mg/day) induces a greater increase in postprandial serum levels of cholecystokinin in patients with chronic constipation.
    Evaluar si existe una relación entre la magnitud de aumento de los niveles de CCK y la magnitud del reflejo gastrocólico en condiciones fisiológicas.
    Evaluar si existe una relación temporal entre los niveles de CCK y la duración del reflejo gastrocólico en condiciones fisiológicas.
    Evaluar si prucaloprida (2 mg) induce un mayor aumento de los niveles séricos de colecistoquinina postprandiales.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    >18 and <65 years of age
    Ability to communicate appropriately
    Meeting the Rome III criteria for functional chronic constipation
    Having an approved indication for the clinical use of prucalopride
    - Género femenino
    -Tener una edad > 18 años y menor de 65
    -Capacidad adecuada para comunicarse
    -Cumplir los criterios Roma III para estreñimiento crónico funcional
    -Refractariedad a tratamiento con laxantes.
    E.4Principal exclusion criteria
    Existence of any relevant organic and/or systemic disease
    Use of medication(s) known to interfere with gastrointestinal motility
    Cases in which constipation is secondary to drugs or systemic disease(s).
    Inability to sign informed consent
    - Género masculino.
    -Existencia de alguna enfermedad orgánica y/o sistémica relevante.
    -Consumo de medicación que interfiera en la motilidad gastrointestinal (procinéticos, laxantes, antidiarreicos y espamolíticos). No deben haberlos consumido al menos 2 semanas previas a la fecha de inclusión en el estudio.
    - Estreñimiento secundario a fármacos o enfermedades sistémicas.
    - Embarazo o lactancia.
    -Incapacidad para firmar el consentimiento informado
    E.5 End points
    E.5.1Primary end point(s)
    Gastrocolic reflex: defined as the decrease in rectal volume produced after eating. This is quantified as follows:
    Magnitude: defined as the percentage of volume decrease in the first half-hour after eating with respect to the volume 30 minutes prior to food intake.
    Duration: defined as the time necessary to recover 50% of the decrease in rectal volume after food intake, with a maximum of 2 hours.
    Gastrocolic reflex stimulation: defined as the increase in serum CCK levels after food intake, evaluating the maximum concentration achieved and the time to maximum concentration
    Magnitud del reflejo gastrocólico: se define como el porcentaje de disminución del volumen rectal en la primera media hora tras la ingesta respecto a la media hora previa a la ingesta.
    Duración del reflejo gastrocólico: se define como el tiempo necesario para recuperar el 50% de la disminución del volumen rectal tras la ingesta, con un máximo de 2 horas.
    Se evaluará el reflejo gastrocólico mediante la realización de estudio del tono rectal con baróstato electrónico (cambios en el tono basal pre y postingesta) y determinación de los niveles sanguíneos de colecistoquinina (niveles pre y postingesta) a través de analítica
    E.5.1.1Timepoint(s) of evaluation of this end point
    baseline appointment and at the end of the first week
    al inicio del paciente en el estudio y una semana después
    E.5.2Secondary end point(s)
    not aplicable
    no aplica
    E.5.2.1Timepoint(s) of evaluation of this end point
    not aplicable
    no aplica
    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 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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    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 Yes
    E.8.2.3.1Comparator description
    situacion fisiologica del paciente
    patients physiological conditions
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA 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
    Se considerará el final del ensayo clínico la última visita que realice el último sujeto que haya sido incluido en el estudio
    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 months3
    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: 10
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 state10
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 10
    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)
    Patients will continue with clinical follow-up at the discretion of the principal
    investigator
    Los pacientes continuarán con seguimiento clínico a criterio del investigador
    principal
    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 Decision2013-07-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-05-09
    P. End of Trial
    P.End of Trial StatusOngoing
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