Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44335   clinical trials with a EudraCT protocol, of which   7366   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2017-004898-14
    Sponsor's Protocol Code Number:MgSO4-konc
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-02-13
    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 ConcernedSweden - MPA
    A.2EudraCT number2017-004898-14
    A.3Full title of the trial
    See down below.
    Maternella serum koncentrationen av magnesium under 24 timmar efter en bolusdos (6g) av magnesiumsulfat vid hotande förtidsbörd
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    See down below.
    Maternella serum koncentrationen av magnesium under 24 timmar efter en bolusdos (6g) av magnesiumsulfat vid hotande förtidsbörd
    A.4.1Sponsor's protocol code numberMgSO4-konc
    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 SponsorSahlgrenska University Hospital
    B.1.3.4CountrySweden
    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 supportFrimurare Barnhusdirektionen
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGothia Forum
    B.5.2Functional name of contact pointResearch Support Office
    B.5.3 Address:
    B.5.3.1Street AddressGröna Stråket 12
    B.5.3.2Town/ cityGothenburg
    B.5.3.3Post code41345
    B.5.3.4CountrySweden
    B.5.6E-mailgothia.forum@vgregion.se
    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 Magnesium Sulfate 50%w/v Solution for Injection
    D.2.1.1.2Name of the Marketing Authorisation holderAurum Pharmaceuticals Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMAGNESIUM SULFATE HEPTAHYDRATE
    D.3.9.1CAS number 10034-99-8
    D.3.9.3Other descriptive nameMAGNESIUM SULFATE HEPTAHYDRATE
    D.3.9.4EV Substance CodeSUB14449MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/V) percent weight/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    Please see below
    Neurologiska handikapp, såsom cerebral pares, blindhet och kognitiva problem hos barn födda i vecka 23-32
    E.1.1.1Medical condition in easily understood language
    Please see below
    Neurologiska handikapp, såsom cerebral pares, blindhet och kognitiva problem hos barn födda i vecka 23-32
    E.1.1.2Therapeutic area Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
    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
    Please see below
    Primär frågeställning: Att kartlägga maternella koncentrationen av magnesium (Mg) under ett dygn hos modern efter en terapeutisk dos (6g som bolus) av MgSO4 vid hotande förtidsbörd.
    E.2.2Secondary objectives of the trial
    Please see below
    - Studera eventuella biverkningar hos modern.
    - Studera magnesiumnivåer hos det nyfödda barnet
    Utvärdera 6g MgSO4 som bolusdos genom att studera distributionen av Mg under 24 timmar. Detta för att försäkra oss om att Mg koncentrationen inte överstiger 4 mmol/l vid någon tidpunkt samt att terapeutisk nivå (2-4 mmol/L) uppnås. Slutligen notera eventuella biverkningar hos mor och därmed övervakningsbehov inför framtiden. Detta i syfte att i ett senare skede kunna implementera en bolusdos MgSO4 (6g) vid hotande förtidsbörd i graviditetsvecka 23-32 i Sverige som hjärnskyddande behandling.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Please see below
    För att inkluderas I studien så måste deltagare uppfylla följande kriterium:
    1. Signerat informed consent form
    2. Kvinna i graviditetsvecka 23+0-32+0
    3. Förtidigt värkarbete
    4. Livmodertapp (cervix) öppen 3 cm el mer, och/eller buktande hinnblåsa och/eller vattenavgång med beräknad förlossning inom 24 h.
    5. Vikt mellan 60-100kg
    E.4Principal exclusion criteria
    Please see below
    Deltagare som uppfyller något av nedanstående kriterium får inte gå in i studien:
    1. Kvinna som har en beräknad förlossning inom 1 h
    2. Kvinna som får MgSO4 av annan orsak i behandlande syfte
    3. Nedsatt njurfunktion hos kvinnan
    4. Foster med kända fetala anomalier
    5. Kvinna med Myastenia Gravis
    E.5 End points
    E.5.1Primary end point(s)
    Please see below
    Magnesiumkoncentration i serum
    E.5.1.1Timepoint(s) of evaluation of this end point
    Please see below
    Blodprov för att analysera Mg koncentration i plasma kommer att tas vid 20 min, 1, 2, 6 och 24 timmar efter påbörjad infusion
    E.5.2Secondary end point(s)
    Please see below
    1. Magnesiumkoncentration i serum från barnets navelsträngsblod

    2. Övervakning av allmäntillstånd, andningsfrekvens, reflexer, rodnad/flushkänsla, urinproduktion
    E.5.2.1Timepoint(s) of evaluation of this end point
    Please see below
    1. Navelsträngsblod från barnet kommer att tas i samband med födseln.

    B2. iverkningar kommer att samlas genom att protokoll kommer att föras avseende kvinnans vikt/BMI, aktuella läkemedel, allmäntillstånd, reflexer, värmekänsla samt andningsfrekvens efter 20 min, 1, 2, 6 och 24 timmar efter den påbörjad infusion av bolusdosen.
    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 No
    E.6.6Pharmacokinetic Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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.8.3 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
    Last subject last visit
    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 months6
    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 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 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 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)
    None
    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 Decision2018-04-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-01-24
    P. End of Trial
    P.End of Trial StatusCompleted
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri May 09 09:49:47 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA