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    Summary
    EudraCT Number:2014-004249-29
    Sponsor's Protocol Code Number:DALMATION/7212
    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:2017-08-21
    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 number2014-004249-29
    A.3Full title of the trial
    An Open Label, Non-Randomised, Phase II study to Determine if Dabigatran and its Metabolites are Detectable in Breast Milk Following Oral Administration to Non-Breastfeeding Mothers
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Determine if Dabigatran is Detectable in Breast Milk Following Oral Administration to Non-Breastfeeding Mothers.
    A.3.2Name or abbreviated title of the trial where available
    Dabigatran Presence in Breast Milk (DALMATION)
    A.4.1Sponsor's protocol code numberDALMATION/7212
    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 SponsorThe Newcastle Upon Tyne Hospitals NHS Foundation Trust
    B.1.3.4CountryUnited Kingdom
    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 supportBoehringer Ingelheim
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNewcastle University
    B.5.2Functional name of contact pointJenn Walker
    B.5.3 Address:
    B.5.3.1Street Address1-4 Claremont Terrace
    B.5.3.2Town/ cityNewcastle Upon Tyne
    B.5.3.3Post codeNE2 4AE
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01912082520
    B.5.6E-mailjenn.walker@newcastle.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 Pradaxa
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim International GmbH
    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 nameDabigatran etexilate 110mg
    D.3.4Pharmaceutical form Capsule, hard
    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 INNdabigatran etexilate as mesilate
    D.3.9.1CAS number 211915-06-9
    D.3.9.2Current sponsor code7212
    D.3.9.3Other descriptive namePradaxa
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number110
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Future use for VTE prophylaxis.
    E.1.1.1Medical condition in easily understood language
    First steps to see if Dabigatran could be used in the future for women who have had a Caesarean section in order to reduce the risk of blood clots.
    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
    The primary objective of the study is to determine if dabigatran and its metabolites are detectable in breast milk following oral administration to non-breast feeding mothers.

    E.2.2Secondary objectives of the trial
    The secondary objective is to determine dabigatran pharmacokinetics (Tmax, Cmax, t1/2, AUC) in maternal plasma and breast milk (if dabigatran is detectable in breast milk).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Women aged ≥18 years
    • Woman has had a vaginal birth (spontaneous or instrumental)
    • Minimum of 48 hours has passed after delivery of the baby/ removal of epidural catheter or spinal anaesthesia
    • Minimum of 24 hours has passed after the decision has been made and documented in the notes to stop breast feeding the baby after starting/trying to start.
    • Hospital inpatient
    • Woman has been offered the opportunity to have a discussion at delivery and in the immediate postnatal period in relation to their feeding choices using the Feeding Your Baby booklet.
    • Decision has been confirmed by the woman to exclusively formula-feed her baby (including women who have since decided to stop breast-feeding their baby)
    • Midwife has confirmed the decision with the woman and has documented this in the Feeding Your Baby Booklet held in the medical notes.
    • Normal renal function test – results of the serum creatinine <90 micro mol/L.
    • Normal liver function tests – results of the serum ALT </= 40 IU/L.
    • Not taking any medication except paracetamol and / or dihydrocodeine. Women who have been given ibuprofen for pain relief after delivery can be included at least 24 hours after the last dose. Women will be advised not to take non-steroidal anti-inflammatory drugs (aspirin, ibuprofen, diclofenac, naproxen, indometnacin) for at least 3 days after taking the study treatment)
    • Participant has provided written informed consent for participation in the study before any study specific procedures take place.
    E.4Principal exclusion criteria
    • Women who are planning to/are breastfeeding
    • Women who are planning to/giving their baby expressed breast milk
    • Women who are unsure of their decision to breast feed or formula feed
    • Women who are unable to provide written informed consent
    • LMWH thromboprophylaxis is indicated
    • Increased risk of bleeding for any reason
    • An increased tendency to bleed (inborn, of unknown cause or due to other medications)
    • Known contra-indications to dabigatran
    • On-going treatment with aspirin, NSAIDs or other drugs that affect haemostasis
    • Treatment with oral ketoconazole or itraconazole, medicines to treat fungal infections
    • Patients who have received an artificial heart valve, have had a heart attack or suffer an irregular heartbeat (including taking dronedarone)
    • Known impaired renal function (serum creatinine > 90 micro mol/L)
    • Known abnormal liver function tests (ALT > 40 IU/L)
    • Known hypersensitivity or allergy to dabigatran
    • Use of other investigational study drugs within 30 days prior to study entry
    E.5 End points
    E.5.1Primary end point(s)
    To determine if Dabigatran is detectable in plasma and breast milk after it has been ingested by the mother.
    E.5.1.1Timepoint(s) of evaluation of this end point
    This will be measured at 0,1,2,5,7,10 hours after swallowing two 110mg capsules of
    dabigatran.
    E.5.2Secondary end point(s)
    If Dabigatran is detected:

    Time course of dabigatran concentration in breast milk.

    Time course of dabigatran concentration in maternal plasma.
    E.5.2.1Timepoint(s) of evaluation of this end point
    This will be measured across the 0,1,2,5,7,10 hours after swallowing two 110mg capsules of dabigatran.
    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 Information not present in EudraCT
    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 No
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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
    Database lock (all queries raised and resolved) and no further follow up data can be entered.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days29
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days30
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    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) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 10
    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 Yes
    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 Yes
    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 state10
    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)
    The IMP will be administered once...
    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 North East & North Cumbria Clinical Research Network
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-10-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-10-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-12-31
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