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    Summary
    EudraCT Number:2017-002694-19
    Sponsor's Protocol Code Number:62449
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2018-02-19
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2017-002694-19
    A.3Full title of the trial
    Mifepristone and misoprostol versus misoprostol alone for uterine evacuation after early pregnancy failure: a randomized double blind placebo-controlled comparison (M&M trial).
    Mifepristone en misoprostol versus misoprostol alleen voor uteriene evacuatie na een miskraam: een gerandomiseerde, dubbelblinde, placebo-gecontroleerde vergelijking (M&M studie).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparing two medical treatments for early pregnancy failure.
    Het vergelijken van twee medicamenteuze behandelingen bij een miskraam.
    A.3.2Name or abbreviated title of the trial where available
    Triple M trial
    Triple M studie
    A.4.1Sponsor's protocol code number62449
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03212352
    A.5.4Other Identifiers
    Name:Nederlands Trial RegisterNumber:NTR6550
    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 SponsorRadboud University Medical Centre
    B.1.3.4CountryNetherlands
    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 supportInnovatiefonds Zorgverzekeraars
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportCanisius Wilhelmina Ziekenhuis
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportRadboud Universitair Medisch Centrum
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCanisius Wilhelmina Ziekenhuis
    B.5.2Functional name of contact pointSecretariat of Gynaecology
    B.5.3 Address:
    B.5.3.1Street AddressWeg door Jonkerboos 100
    B.5.3.2Town/ cityNijmegen
    B.5.3.3Post code6532 SZ
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031243657850
    B.5.5Fax number0031243657852
    B.5.6E-maill.hamel@cwz.nl
    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 Mifegyne
    D.2.1.1.2Name of the Marketing Authorisation holderExcelgyn
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameMifegyne
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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 placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Early pregnancy failure
    Miskraam
    E.1.1.1Medical condition in easily understood language
    Early pregnancy failure
    Miskraam
    E.1.1.2Therapeutic area Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
    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 identify whether Mifepristone in combination with Misoprostol is more effective in uterine evacuation after early pregnancy failure than Misoprostol alone.
    Om vast te stellen of Mifepristone in combinatie met Misoprostol effectiever is in uteriene evacuatie na een miskraam dan Misoprostol alleen
    E.2.2Secondary objectives of the trial
    patient satisfaction, complications, side effects and costs
    patiënttevredenheid, complicaties, bijwerkingen en kosten
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Early pregnancy failure, 6-14 weeks postmenstrual with
    - a crown-rump length ≥ 6mm and no cardiac activity OR
    - a crown-rump length <6mm and no fetal growth at least one week later OR
    - a gestational sac with absent embryonic pole for at least one week.

    • At least one week after diagnosis OR a discrepancy of at least one week between crown­rump length and calendar gestational age
    • Intra­uterine pregnancy
    • Women aged above 18 years
    • Hemodynamic stable patient
    • No signs of infection
    • No signs of incomplete abortion
    • No contraindications for mifepristone or misoprostol
    • No high risk of thrombosis
    Niet-vitale zwangerschap, 6-14 weken amenorroeduur met
    - een crown-rump length ≥ 6mm zonder hartactie OF
    - een crown-rump length <6mm zonder foetale groei minstens een week later OF
    - een vruchtzak zonder embryonale delen, minstens 1 week later echoscopisch bevestigd

    • Tenminste 1 week na de diagnose OF een discrepantie van tenminste 1 week tussen de crown­rump length en amenorroeduur
    • Intra­uteriene zwangerschap
    • Vrouwen ouder dan 18 jaar
    • Haemodynamisch stabiele patient
    • Geen tekenen van infectie
    • Geen tekenen van incomplete miskraam
    • Geen contra­indicatie voor mifepristone of misoprostol
    • Geen verhoogd risico op trombose
    E.4Principal exclusion criteria
    Patient does not meet inclusion criteria, discovered after randomization.
    Inability to give informed consent.
    Interaction between study-medication and other medicine.
    Contra-indications for the use of Mifepristone and/or Misoprostol.
    Language barrier
    Patient voldoet niet aan de inclusie criteria, pas ontdekt na randomiseren.
    Het geven van informed consent is niet mogelijk.
    Interactie tussen studiemedicatie en andere medicijnen.
    Contra-indicaties voor het gebruik van Mifepriston en/of Misoprostol.
    Taalbarrière.
    E.5 End points
    E.5.1Primary end point(s)
    Complete evacuation of the uterus, which is determined as a total endometrial thickness of less then 15 mm.
    Volledige evacuatie van de uterus, vastgesteld als een totale endometriumdikte van minder dan 15 mm.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The first evaluation will take place 15- 20 days after initial treatment. If a complete evacuation hasn't occured at that time, a second evaluation will take place six weeks after the initial treatment.
    De eerste evaluatie zal 15-20 dagen na de initiële behandeling plaatsvinden. Wanneer er dan nog geen complete evacuatie heeft plaatsgevonden zal een tweede evaluatie plaatsvinden zes weken na de initiële behandeling.
    E.5.2Secondary end point(s)
    patient satisfaction, complications, side-effects and costs.
    patiënttevredenheid, complicaties, bijwerkingen en kosten
    E.5.2.1Timepoint(s) of evaluation of this end point
    two and six weeks after initial treatment.
    twee en zes weken na de initiële behandeling
    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 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 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 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 concerned7
    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
    A blinded interim analysis will be done using O’Brien-Fleming stopping rules. This means that if the treatment is particularly beneficial or harmful compared to the control group, the investigators will be able to make a deliberate consideration of terminating the study earlier.
    If with this interim analysis no reason is found to end the study prematurely the end of the trial will be the last visit of the last subject undergoing the trial.
    Een geblindeerde interim-analyse middels O-Brien-Fleming stopregels zal worden uitgevoerd. Als de behandeling bijzonder voordelig dan wel gevaarlijk is vergeleken met de controlegroep, kunnen de onderzoekers een weloverwogen beslissing kunnen maken over het eerder beëindigen van de studie.
    Indien uit de interim-analyse geen reden naar voren komt om de studie voortijdig te beëindigen zal het einde van de studie het moment zijn waarop het laatste bezoek van de laatste studiepatiënt plaatsvindt
    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 months6
    E.8.9.1In the Member State concerned days
    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: 464
    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 state460
    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)
    Only when there has not been a complete uterine evacuation additional treatment, for example a curettage, will take place.
    Alleen wanneer er geen volledige uteriene evacuatie heeft plaatsgevonden zal aanvullende behandeling, bijvoorbeeld middels curettage plaatsvinden.
    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 Decision2018-02-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-01-16
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2020-01-23
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