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    Summary
    EudraCT Number:2016-005097-35
    Sponsor's Protocol Code Number:RG_16-076
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-10-09
    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 ConcernedUK - MHRA
    A.2EudraCT number2016-005097-35
    A.3Full title of the trial
    A randomised placebo-controlled trial of mifepristone and misoprostol versus misoprostol alone in the medical management of missed miscarriage
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A trial to test if using a combination of drugs (mifepristone followed by misoprostol) is better than giving misoprostol alone to more quickly resolve a miscarriage.
    A.3.2Name or abbreviated title of the trial where available
    MifeMiso
    A.4.1Sponsor's protocol code numberRG_16-076
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN17405024
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03065660
    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 SponsorUniversity of Birmingham
    B.1.3.4Country
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Birmingham
    B.5.2Functional name of contact pointLeanne Beeson
    B.5.3 Address:
    B.5.3.1Street AddressPublic Health Building, Institute of Applied Health Research
    B.5.3.2Town/ cityBirmingham
    B.5.3.3Post codeB15 2TT
    B.5.4Telephone number01214149011
    B.5.6E-maill.e.beeson@bham.ac.uk
    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 200mg Tablets
    D.2.1.1.2Name of the Marketing Authorisation holderExelgyn
    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.3.1Product nameMifegyne 200mg Tablets
    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 INNMifepristone
    D.3.9.1CAS number 84371-65-3
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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
    Missed miscarriage up to 13+6 weeks gestation.
    E.1.1.1Medical condition in easily understood language
    Women suffering a miscarriage where the tissue from the pregnancy is still inside the womb up to 13+6 weeks gestation.
    E.1.1.2Therapeutic area Body processes [G] - Reproductive physiologi cal processes [G08]
    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 test the hypothesis that in women diagnosed with missed miscarriage before 13+6 weeks gestation, mifepristone (200mg orally) followed by misoprostol 800mcg taken vaginally or orally two days later (MifeMiso) increases the passage of the gestational sac within seven days after randomisation, when compared to a placebo tablet with identical appearance to the mifepristone tablet followed by misoprostol 800mcg taken vaginally or orally two days later.
    E.2.2Secondary objectives of the trial
    To test the hypothesis that MifeMiso, compared with misoprostol alone improves secondary outcomes including the need for: further doses of misoprostol, surgery or blood transfusion, total days of bleeding, infection requiring antibiotics, infection requiring inpatient treatment, pregnancy test result 21 days after randomisation, time from randomisation to discharge, patient satisfaction, cost-effectiveness of the additional treatment, side effects and death or serious complications. We will also explore the effects of MifeMiso combination versus misoprostol alone in particular subgroups, including age and gestation at missed miscarriage diagnosis.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Women diagnosed with missed miscarriage by pelvic ultrasound scan in the first 13+6 weeks of pregnancy.
    2. Age 16 years and over.
    3. Willing and able to give informed consent.
    E.4Principal exclusion criteria
    1. Women opting for alternative methods of miscarriage management (expectant or surgical)
    2. Diagnosis of incomplete miscarriage.
    3. Life threatening bleeding.
    4. Contraindications to mifepristone or misoprostol use for example chronic adrenal failure, known hypersensitivity to either drug, haemorrhagic disorders and anticoagulant therapy, prosthetic heart valve or history of endocarditis, existing cardiovascular disease, severe asthma uncontrolled by therapy or inherited porphyria.
    5. Participation in any other blinded, placebo-controlled trials of investigational medicinal products in pregnancy.
    6. Previous participation in the MifeMiso trial
    7. Woman not able to attend for day 6-7 ultrasound scan
    E.5 End points
    E.5.1Primary end point(s)
    Failure to spontaneously pass the gestational sac within 7 days after randomisation
    E.5.1.1Timepoint(s) of evaluation of this end point
    7 days after randomisation.
    E.5.2Secondary end point(s)
    Need for further doses of misoprostol up to day 7 post-randomisation
    Need for further doses of misoprostol up to discharge from EPU care
    Time from randomisation to passage of gestational sac (diagnosed by USS).
    Time from active treatment (defined as mifepristone in the active group and misoprostol in the placebo group) commencement to passage of gestational sac. (diagnosed by USS).
    Surgical intervention to resolve the miscarriage (collected up to discharge from EPU care)
    Overall patient satisfaction score (measured using the CSQ-8 questionnaire and collected upon discharge from EPU care).
    Patient quality of life (Index value and overall health status measured using the EQ-5D-5L questionnaire and collected on date of randomisation, day 6-7 post-randomisation or day of follow-up USS if different to day 6-7 and day 21 +/- 2 days post-randomisation. If a woman obtains an initial positive pregnancy test result at day 21 +/- 2 days post-randomisation then a further EQ-5D-5L questionnaire is collected upon discharge from EPU care).
    Blood transfusion required (collected up to discharge from EPU care)
    Duration of bleeding reported by woman (days). (collected up to discharge from EPU care)
    Diagnosis of infection associated with miscarriage requiring outpatient antibiotic treatment (collected up to discharge from EPU care)
    Diagnosis of infection associated with miscarriage requiring inpatient antibiotic treatment (collected up to discharge from EPU care)
    Negative pregnancy test result 21 days (± 2 days) after randomisation.
    Time from randomisation to discharge from EPU care.
    Side effects (collected up to discharge from EPU care)
    Death (collected up to discharge from EPU care)
    Any serious complications (collected up to discharge from EPU care)
    E.5.2.1Timepoint(s) of evaluation of this end point
    21 days after randomisation for the clinical outcomes. A subset of patients will be selected for an in depth interview to discuss the treatment they received up to 6 weeks after discharge.
    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 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) Yes
    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 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 concerned32
    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
    The interventional phase of the trial will end when the last woman recruited has taken her last dose of the trial treatment. The observational phase of the trial to assess clinical outcomes will cease when the final outcome of the woman has been completed and data has been entered onto the database and validated as being ready for analysis. The last woman interviewed from the subset of women selected for interview up to 6 weeks after discharge will be used to define the end of trial.
    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 months11
    E.8.9.1In the Member State concerned days31
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days31
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 20
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 20
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 690
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 No
    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 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 state710
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 710
    F.4.2.2In the whole clinical trial 710
    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)
    Study participants will be given mifepristone or placebo, followed by misoprostol two days later. If the miscarriage has not resolved after seven days, a clinical decision will be made by the local team as to whether further misoprostol should be administered, or whether a different intervention is required. There is no need for provision of the investigational medicinal product after the first administration.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation NIHR Clinical Research Network: West Midlands
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-03-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-02-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-01-09
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