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    Summary
    EudraCT Number:2011-002095-17
    Sponsor's Protocol Code Number:MAGSPET
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-07-19
    Trial results View 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 number2011-002095-17
    A.3Full title of the trial
    Sulfato de magnesio en pauta continua versus discontinua en la conducta expectante de la preeclampsia grave: ensayo clínico aleatorizado
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Magnesium sulphate in continuous administration compare to discontinuous administration in the expectant management of severe preeclampsia: randomized controlled trial
    A.4.1Sponsor's protocol code numberMAGSPET
    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 SponsorAnna Suy Franch
    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 supportAnna Suy Franch
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAnna Suy Franch
    B.5.2Functional name of contact pointAnna Suy Franch
    B.5.3 Address:
    B.5.3.1Street AddressPasseig de la Vall d'Hebron, 129-135
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08035
    B.5.3.4CountrySpain
    B.5.4Telephone number349327490254954
    B.5.5Fax number34934894102
    B.5.6E-mailasuy@vhebron.net
    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 Sulfate de Magnesium Lavoisier
    D.2.1.1.2Name of the Marketing Authorisation holderCDM Lavoisier
    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.3.1Product nameMagnesium sulfate
    D.3.4Pharmaceutical form Solution for infusion
    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 INNMagnesium sulphate
    D.3.9.1CAS number 7487-88-9
    D.3.9.3Other descriptive nameSulfato de magnesio
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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
    Preeclampsia grave
    E.1.1.1Medical condition in easily understood language
    Seizures during pregnancy
    E.1.1.2Therapeutic area Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10040445
    E.1.2Term Severe pre-eclampsia, antepartum
    E.1.2System Organ Class 10036585 - Pregnancy, puerperium and perinatal conditions
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine whether continuous administration of magnesium sulfate prolongs pregnancy more days compared to discontinuous administration
    Determinar si la administración de sulfato de magnesio de forma continua prolonga la gestación un mayor número de días en comparación a su administración de forma discontinua
    E.2.2Secondary objectives of the trial
    1. To evaluate and compare the incidence of maternal complications according to treatment regimen: death, eclampsia, placental abruption usually inserted (abruptio placentae), hemorrhage, acute pulmonary edema, acute renal failure, cerebral edema.
    2. To evaluate and compare the incidence of fetal complications (death, cerebral palsy, intraventricular hemorrhage, respiratory distress, persistent patent ductus arteriosus refractory to medical treatment).
    3. To evaluate fetal hemodynamic evolution and its association with perinatal outcomes according to the prescription given.
    4. To evaluate the prognostic role of angiogenic factors in the expectant management of severe preeclampsia
    1.- Evaluar y comparar la incidencia de complicaciones maternas en función de la pauta de tratamiento: muerte, eclampsia, desprendimiento de placenta normalmente inserta (DPPNI), hemorragia, edema agudo de pulmón, insuficiencia renal aguda, edema cerebral.
    2.- Evaluar y comparar la incidencia de complicaciones fetales: muerte, parálisis cerebral, hemorragia intraventricular, alteraciones respiratorias, persistencia de ductus arterioso permeable resistente al tratamiento médico
    3.- Evaluar la evolución hemodinámica fetal y su asociación a los resultados perinatales en función de la pauta administrada.
    4.- Evaluar el papel pronóstico de los factores angiogénicos en la conducta expectante de la preeclampsia grave
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age >= 18 years
    - Pregnant women of 24.0 - 33.6 weeks with severe preeclampsia after 24 h of treatment with intravenous magnesium sulfate (4 g bolus followed by continuous infusion pump 1 g / h). They include multiple pregnancies, HELLP syndrome, oligohydramnios, intrauterine growth retardation (IUGR) and patients with associated medical conditions who don't meet the exclusion criteria
    - Edad >= 18 years
    - Pregnant women of 24.0 - 33.6 weeks con preeclampsia grave tras 24h de tratamiento con sulfato de magnesio endovenoso (bolus de 4 gr seguido de bomba de perfusión continua a 1gr/h). Se incluirán gestaciones múltiples, síndrome HELLP, oligoamnios, retraso de crecimiento intrauterino (RCIU) y pacientes con patología médica asociada que no
    cumplan los criterios de exclusión
    E.4Principal exclusion criteria
    Eclampsia, uncontrolled blood pressure at maximum doses of two antihypertensive drugs, acute pulmonary edema, abruptio placenta, fetal death on admission, suspected fetal welfare loss. Patients with myasthenia gravis, myocardial involvement or cardiac conduction defects
    Eclampsia, tensión arterial incontrolable con dosis máximas de dos fármacos antihipertensivos, edema agudo de pulmón, DPPNI, óbito al ingreso, sospecha de pérdida de bienestar fetal. Pacientes con miastenia gravis, compromiso miocárdico o defectos de conducción cardiaca
    E.5 End points
    E.5.1Primary end point(s)
    Days after inclusion in the study until delivery
    Días transcurridos desde la inclusión en el estudio hasta el parto
    E.5.1.1Timepoint(s) of evaluation of this end point
    Daily control
    E.5.2Secondary end point(s)
    Maternal complications:
    Placental abruption
    Acute pulmonary edema
    Eclampsia
    Renal insufficiency
    ICU admission
    Fetal/neonatal complications:
    Intrauterine death
    Perinatal death
    Intraventricular hemorrhage
    Respiratory Distress
    Retinopathy of prematurity
    Neonatal sepsis
    Maternas
    · Desprendimiento de placenta
    · Edema agudo de pulmón
    · Eclampsia
    · Insuficiencia renal
    · Ingreso en UCI
    Fetales/neonatales
    · Óbito intraútero
    · Muerte perinatal
    · Hemorragia intraventricular
    · Distrés respiratorio
    · Retinopatía del prematuro
    · Sépsis neonatal
    E.5.2.1Timepoint(s) of evaluation of this end point
    Daily control
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Se comparan 2 pautas de administración (continua y discontinua) de un mismo principio activo
    We compare two dosing schedules (continuous and discontinuous) of the same active component
    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 Information not present in EudraCT
    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 the trial will be considered as the final visit of the last patient recruited and her offspring
    El ensayo se considerará finalizado tras la visita de control de la última paciente reclutada y de su descendencia
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 92
    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 Yes
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women Yes
    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 state92
    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)
    At the end of their participation in the trial, subjects will receive the most appropriate treatment for their condition according to normal practice
    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 Decision2011-09-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-07-20
    P. End of Trial
    P.End of Trial StatusCompleted
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