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    Summary
    EudraCT Number:2008-006782-83
    Sponsor's Protocol Code Number:EC08/00230
    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:2013-05-16
    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 number2008-006782-83
    A.3Full title of the trial
    Prevention MODS by modulating the inflammatory response through
    melatonin administration in surgical patients with severe sepsis.
    Prevención del MODS mediante la modulación de la respuesta inflamatoria sistémica a través de
    la administración de melatonina en pacientes quirúrgicos con sepsis severa.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial of melatonin for the study of abdominal surgery patients with sepsis may develop multiorgan failure.
    Ensayo clínico con melatonina para el estudio de pacientes de cirugia abdominal con sepsis que pueden desarrollar un fracaso multiorgánico.
    A.4.1Sponsor's protocol code numberEC08/00230
    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 SponsorHospital Universitario Virgen de las Nieves
    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 supportHospital Universitario Virgen de las Nieves
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital Universitario Virgen de las Nieves
    B.5.2Functional name of contact pointPablo Bueno Laraño
    B.5.3 Address:
    B.5.3.1Street Addressc/ Doctor Azpitarte, nº4
    B.5.3.2Town/ cityGranada
    B.5.3.3Post code18012
    B.5.3.4CountrySpain
    B.5.4Telephone number958020213
    B.5.5Fax number958020044
    B.5.6E-mailpablo.bueno.exts@juntadeandalucia.es
    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 nameMELATONIN INJECTABLE
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMelatonin
    D.3.9.1CAS number 73-31-4
    D.3.9.2Current sponsor codeEC 08/00230
    D.3.9.3Other descriptive nameMELATONIN
    D.3.9.4EV Substance CodeSUB14496MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Septic patients of abdominal surgery
    PACIENTES SEPTICOS DE CIRUGIA ABDOMINAL
    E.1.1.1Medical condition in easily understood language
    Septic patients of abdominal surgery
    PACIENTES SEPTICOS DE CIRUGIA ABDOMINAL
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
    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
    Primary objective: To reduce the incidence of multiple organ dysfunction syndrome (MODS) in
    abdominal surgery patients with severe sepsis
    Objetivo primario: Disminuir la incidencia del Síndrome de Disfunción Orgánica Múltiple (MODS) en
    pacientes de cirugía abdominal con sepsis severa
    E.2.2Secondary objectives of the trial
    Objective: 1) To study the inflammatory response by measuring cytokine
    index of lipid peroxidation (levels of malondialdehyde) in the study groups: melatonin,
    placebo and reference. 2) To evaluate clinical and immunological response resulting from administration of
    melatonin. 3) Evaluate the degree of organ dysfunction developed in the patients studied. 4)
    To study the correlation between the treatment given, the modulation of the parameters studied
    and the development of MODS.
    Objetivo secundarios: 1) Estudiar la respuesta inflamatoria mediante la determinación de citoquinas y
    del índice de peroxidación lipídica (niveles de malondialdehido) en los grupos de estudio: melatonina,
    placebo y de referencia. 2) Evaluar respuesta clínica e inmunológica derivada de la administración de
    melatonina. 3) Evaluar el grado de disfunción orgánica desarrollado en los pacientes estudiados. 4)
    Estudiar la correlación entre el tratamiento administrado, la modulación de los parámetros estudiados
    y el desarrollo del MODS.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients who are in clinical status from "severe sepsis" according to the diagnostic criteria
    "American College of Chest Physicians / Society of Critical Care Medicine" (Annex I), ie
    patients with systemic inflammatory response syndrome associated to infectious etiology dysfunction
    organic, hypoperfusion or hypotension, and will undergo surgery.
    Pacientes que se encuentren en estado clínico de "sepsis severa" según los criterios diagnósticos de la
    "American College of Chest Physicians/Society of Critical Care Medicine" (Anexo I), es decir,
    pacientes con síndrome de respuesta inflamatoria sistémica de etiología infecciosa asociado a disfunción
    orgánica, hipoperfusión o hipotensión, y que vayan a ser intervenidos quirúrgicamente.
    E.4Principal exclusion criteria
    Age under 18 years, pregnancy, medical or surgical terminal disease, hepatic or
    chronic renal disease, psychiatric treatment or refusal to participate in the study.
    Edad menor de 18 años, embarazo, enfermedad terminal médica o quirúrgica, insuficiencia hepática o
    renal crónica, enfermedad psiquiátrica en tratamiento o negativa a participar en el estudio.
    E.5 End points
    E.5.1Primary end point(s)
    ASSESSING inflammatory and immunological response: During the days 0
    (pre-surgery and after administration of melatonin or placebo) and at 1, 2, 3, 4 and 5 days after the surgical intervention will be the determination of plasma levels of cytokines (IL-2, IL-4, IL -6, IL-10, TNF-a and IFN-g), and protein markers of apoptosis (sFas, FasL, sFasL, caspase-3, Bcl-2, and PARP), antioxidant enzymes (superoxide dismutase, SOD), catalase glutathione peroxidase and glutathione reductase) and the levels of lipid peroxidation (malondialdehyde). Also at the same time study will be conducted to determine blood count and differential count.
    Assessment of the functionality of various organic by biochemical systems in plasma obtained from blood samples parameters of transaminases (GOT,
    GPT, GGT), total and direct bilirubin, LDH, urea and creatinine. As levels of calcium, sodium, potassium and chloride.
    VALORACIÓN DE LA RESPUESTA INFLAMATORIA E INMUNOLÓGICA: Durante los días 0
    (pre-intervención quirúrgica y previa administración de melatonina o placebo) y a los 1, 2, 3, 4 y 5 dias posteriores a la intervención quirúrgica se realizará la determinación de los niveles plasmáticos de citoquinas (IL-2, IL-4, IL-6, IL-10, TNF-a e IFN-g), marcadores y proteinas de apoptosis (sFas, FasL, sFasL, caspasa-3, Bcl-2, y PARP), enzimas antioxidantes (superóxido dismutasa, SOD), catalasa glutation peroxidasa y glutation reductasa) así como los niveles de peroxidación lipídica (malondialdehido). Así mismo en los mismos tiempos de estudio se realizará la determinación de hemograma y fórmula leucocitaria.
    Valoración de la funcionalidad de los distintos sistemas orgánicos mediante determinaciones bioquímicas en plasma obtenido de las muestras de sangre de los parámetros transaminasas (GOT,
    GPT, GGT), bilirrubina total y directa, LDH, urea y creatinina. Así como los niveles de calcio, sodio, potasio y cloro.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Clinical evaluation: To evaluate the clinical outcome of patients and
    functional status of their organ systems in the days after surgery, was
    use the rating scale of multiple organ dysfunction syndrome associated with sepsis
    (SOFA) every 24 hours during the study period.
    VALORACION CLINICA: Para valorar la evolución clínica de los pacientes y la
    situación funcional de sus sistemas orgánicos en los días posteriores a la intervención quirúrgica, se
    utilizará la escala de calificación del síndrome de disfunción orgánica múltiple relacionado con la sepsis
    (SOFA) cada 24 horas durante el periodo de estudio.
    E.5.2Secondary end point(s)
    ASSESSING inflammatory and immunological response: During the days 0
    (pre-surgery and after administration of melatonin or placebo) and at 1, 2, 3, 4 and 5 days after the surgical intervention will be the determination of plasma levels of cytokines (IL-2, IL-4, IL -6, IL-10, TNF-a and IFN-g), and protein markers of apoptosis (sFas, FasL, sFasL, caspase-3, Bcl-2, and PARP), antioxidant enzymes (superoxide dismutase, SOD), catalase glutathione peroxidase and glutathione reductase) and the levels of lipid peroxidation (malondialdehyde). Also at the same time study will be conducted to determine blood count and differential count.
    Assessment of the functionality of various organic by biochemical systems in plasma obtained from blood samples parameters of transaminases (GOT,
    GPT, GGT), total and direct bilirubin, LDH, urea and creatinine. As levels of calcium, sodium, potassium and chloride.
    VALORACIÓN DE LA RESPUESTA INFLAMATORIA E INMUNOLÓGICA: Durante los días 0
    (pre-intervención quirúrgica y previa administración de melatonina o placebo) y a los 1, 2, 3, 4 y 5 dias posteriores a la intervención quirúrgica se realizará la determinación de los niveles plasmáticos de citoquinas (IL-2, IL-4, IL-6, IL-10, TNF-a e IFN-g), marcadores y proteinas de apoptosis (sFas, FasL, sFasL, caspasa-3, Bcl-2, y PARP), enzimas antioxidantes (superóxido dismutasa, SOD), catalasa glutation peroxidasa y glutation reductasa) así como los niveles de peroxidación lipídica (malondialdehido). Así mismo en los mismos tiempos de estudio se realizará la determinación de hemograma y fórmula leucocitaria.
    Valoración de la funcionalidad de los distintos sistemas orgánicos mediante determinaciones bioquímicas en plasma obtenido de las muestras de sangre de los parámetros transaminasas (GOT,
    GPT, GGT), bilirrubina total y directa, LDH, urea y creatinina. Así como los niveles de calcio, sodio, potasio y cloro.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Clinical evaluation: To evaluate the clinical outcome of patients and
    functional status of their organ systems in the days after surgery, was
    use the rating scale of multiple organ dysfunction syndrome associated with sepsis
    (SOFA) every 24 hours during the study period.
    VALORACION CLINICA: Para valorar la evolución clínica de los pacientes y la
    situación funcional de sus sistemas orgánicos en los días posteriores a la intervención quirúrgica, se
    utilizará la escala de calificación del síndrome de disfunción orgánica múltiple relacionado con la sepsis
    (SOFA) cada 24 horas durante el periodo de estudio.
    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 No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    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) 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 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 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 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 trial ended with the inclusion of the last patient under study meeting the inclusion criteria.
    El ensayo finaliza con la inclusión del último paciente objeto de estudio que cumpla los criterios de inclusión.
    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 months0
    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: 40
    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 Yes
    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 Yes
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Septic patients abdominal surgery
    Pacientes Sépticos de cirugía abdominal
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    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)
    Usual treatment for septic patients of abdominal surgery
    Tratamiento habitual para pacientes sépticos de cirugia abdominal
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-09-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-09-13
    P. End of Trial
    P.End of Trial StatusOngoing
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