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    Summary
    EudraCT Number:2014-005200-13
    Sponsor's Protocol Code Number:SafePed002
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-06-11
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2014-005200-13
    A.3Full title of the trial
    study of the pharmacokinetics and pharmacodynamics of desmopressin oral lyophilisate - route of administration in the pediatric patient population - SAFEPEDRUG
    Studie naar farmacokinetiek en farmacodynamiek van desmopressine orale lyofylisaat-toedieningsvorm in de pediatrische patiëntenpopulatie - SAFEPEDRUG
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    study of the pharmacokinetics and pharmacodynamics of desmopressin oral lyophilisate - route of administration in the pediatric patient population - SAFEPEDRUG
    Studie naar farmacokinetiek en farmacodynamiek van desmopressine orale lyofylisaat-toedieningsvorm in de pediatrische patiëntenpopulatie - SAFEPEDRUG
    A.4.1Sponsor's protocol code numberSafePed002
    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 SponsorGhent University
    B.1.3.4CountryBelgium
    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 supportIWT
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGhent University Hospital
    B.5.2Functional name of contact pointBimetra Clinics
    B.5.3 Address:
    B.5.3.1Street AddressDe Pintelaan 185
    B.5.3.2Town/ cityGhent
    B.5.3.3Post code9000
    B.5.3.4CountryBelgium
    B.5.4Telephone number+3293320500
    B.5.5Fax number+3293320520
    B.5.6E-mailbimetra.clinics@uzgent.be
    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 Minirin Melt 60 microgram lyophilisaat voor oraal gebruik
    D.2.1.1.2Name of the Marketing Authorisation holderFerring Pharmaceuticals Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 Sublingual tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSublingual use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDESMOPRESSIN
    D.3.9.1CAS number 16679-58-6
    D.3.9.4EV Substance CodeSUB07001MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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.IMP: 2
    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 Minirin Melt 120 microgram lyophilisaat voor oraal gebruik
    D.2.1.1.2Name of the Marketing Authorisation holderFerring Pharmaceuticals Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 Sublingual tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSublingual use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDESMOPRESSIN
    D.3.9.1CAS number 16679-58-6
    D.3.9.4EV Substance CodeSUB07001MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number120 to 240
    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
    therapeutic population: monosympthomatic enuresis nocturna

    diagnostic population: children with a history of a urinary tract infection or suspicion of renal damage who need a renal concentration test
    E.1.1.1Medical condition in easily understood language
    therapeutic population:monosympthomatic enuresis nocturna
    diagnostic population: children with a history of a urinary tract infection or suspicion of renal damage who need a renal concentration test
    E.1.1.2Therapeutic area Body processes [G] - Biological Phenomena [G16]
    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 evaluate the influence of the weight, length and gender on the pharmacokinetcs of desmopressin
    De invloed van gewicht, lengte en geslacht op de farmacokinetiek van desmopressine evalueren.
    E.2.2Secondary objectives of the trial
    to evaluate the pharmacodynamics of desmopressin on children with enuresis nocturna:
    -changes in urinary osmolality
    -anti-diuretic effect
    -duration of activity

    to evaluate the oral lyophilisate as route of administration for the renal concentration test

    to evaluate the safety of despmopressin
    -adverse events
    -vital parameters (blood pressure, heart rate)
    -natremia
    -weight
    Farmacodynamiek van desmopressine bij kinderen met enuresis nocturna:
    -verandering in urinaire osmolalteit,
    -anti-diuretisch effect;
    -en werkingsduur.
    Oraal lyophilisaat als toedieningsvorm voor renale concentratietest evalueren.
    Veiligheid van desmopressine
    -Adverse events
    -Vitale parameters (bloeddruk, hartfrequentie)
    -Natriëmie
    -Gewicht
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -children with uro-nephropathy who need a renal concentration test, or children with monosympthomatic enuresis nocturna and nightly polyuria with lack of efficacy of desmopressin tablet
    -healthy children (cfr medical history and clinical examination)
    -informed consent voluntary signed by the parents or legal guardian
    -age between 6 months and 8 years
    -minimum weight of 8 kg
    -Kinderen met een uro-nefropathie die een renale concentratietest nodig hebben of kinderen met monosymptomatische enuresis nocturna en nachtelijke poly-urie met onvoldoende antwoord op desmopressine tablet, waarbij – volgens de internationale richtlijnen- overgeschakeld wordt naar de MELT-toedieningsvorm.
    -Gezonde kinderen volgens medische voorgeschiedenis en klinisch onderzoek
    -Ouders of voogd van het kind moeten vrijwillig het informed consent-formulier tekenen vooraleer start van de studie
    -Leeftijd tussen 6 maanden en 8 jaar.
    -Gewicht minimum 8 kg
    E.4Principal exclusion criteria
    -diabetes insipidus (proven central diabetes insipidus)
    -renal insufficiency (eGFR < 60ml/min/1,73m²)
    -active urine tract infection (on day of testing, based on clinical data)
    - SIADH (syndrome of inappropriate ADH-release),
    -heart failure
    -clinical significant disease (renal, hepatic, gastrointestinal, pulmonary, cardia, endocrinological or neurological) which could interfere with the evaluation of the end points
    -hypersensitivity of desmopressin and/or the excipients of the lyophilisate (lactose monohydrate, potato starch, povidone, magnesium stearate)
    -the use of antibiotics, diuretics or other medicines (like tricyclic antidepressants, chlorpropamide, oxcarbazepine, selective serotonin reuptake inhibitors, chlorpromazin and carbamazepine) which could influence the diuresis
    -use of medication (like loperamide) which could influence the gastrointestinal motility
    -abnormalities or diseases of the oral cavity which vould influence the release or absorption of the medication
    -diabetes insipidus, (bewezen centrale diabetes insipidus)
    -nierinsufficiëntie (eGFR < 60ml/min/1,73m²)
    -aanwezige urineweginfectie, (op dag van de test, op basis van kliniek)
    -SIADH (syndrome of inappropriate ADH-release),
    -hartfalen,
    -klinisch significante aandoeningen (renaal, lever, gastro-intestinaal, longen, cardiaal, endocrinologisch of neurologisch) die zouden interfereren met de evaluatie van de eindpunten,
    -overgevoeligheid voor desmopressine en/of de hulpstoffen van de smelttablet (namelijk lactose monohydraat, aardappelzetmeel, povidone en magnesiumstearaat)
    -het gebruik van antibiotica, diuretica of andere geneesmiddelen (zoals tricyclische antidepressiva, chlorpropamide, oxcarbazepine, selectieve serotonine-reuptake inhibitoren, chlorpromazine en carbamazepine) die de diurese kunnen beïnvloeden,
    -het gebruik van geneesmiddelen die de darmmotiliteit (zoals loperamide) beïnvloeden en
    -abnormaliteiten of ziekten in de mondholte die de vrijstelling of de absorptie van de medicatie zou kunnen beïnvloeden.
    E.5 End points
    E.5.1Primary end point(s)
    to evaluate the influence of the weight, length and gender on the pharmacokinetcs of desmopressin
    E.5.1.1Timepoint(s) of evaluation of this end point
    after last visit last subject
    E.5.2Secondary end point(s)
    to evaluate the pharmacodynamics of desmopressin on children with enuresis nocturna:
    -changes in urinary osmolality
    -anti-diuretic effect
    -duration of activity

    to evaluate the oral lyophilisate as route of administration for the renal concentration test

    to evaluate the safety of despmopressin
    -adverse events
    -vital parameters (blood pressure, heart rate)
    -natremia
    -weight
    E.5.2.1Timepoint(s) of evaluation of this end point
    after last visit last subject
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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 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
    LVLS
    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 months0
    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 Yes
    F.1.1Number of subjects for this age range: 24
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 4
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 20
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    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 No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    pediatric population (6 months - 8 year)
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state24
    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 Decision2015-07-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-07-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-12-31
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