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    Summary
    EudraCT Number:2011-004138-33
    Sponsor's Protocol Code Number:EnuMel-11
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2011-12-15
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2011-004138-33
    A.3Full title of the trial
    The effect of melatonin on nocturnal enuresis
    Melatonins effekt på enuresis nocturna
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effect of melatonin on bedwetting
    Melatonins effekt på sengevædning
    A.4.1Sponsor's protocol code numberEnuMel-11
    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 SponsorSøren Rittig
    B.1.3.4CountryDenmark
    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 supportAarhus University Hospital
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAarhus University Hospital
    B.5.2Functional name of contact pointBritt Borg
    B.5.3 Address:
    B.5.3.1Street AddressBrendstrupgaardsvej 100
    B.5.3.2Town/ cityAarhus N
    B.5.3.3Post code8200
    B.5.3.4CountryDenmark
    B.5.4Telephone number004522740973
    B.5.6E-mailbritt.borg@studmed.au.dk
    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 Circadin
    D.2.1.1.2Name of the Marketing Authorisation holderRAD Neurim Pharmaceuticals EEC Limited
    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 nameCircadin
    D.3.4Pharmaceutical form Capsule
    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 INNmelatonin
    D.3.9.1CAS number 73-31-4
    D.3.9.3Other descriptive nameMELATONIN
    D.3.9.4EV Substance CodeSUB14496MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number2 to 4
    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 placeboCapsule
    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
    nocturnal enuresis
    Enuresis nocturna
    E.1.1.1Medical condition in easily understood language
    bedwetting
    sengevædning
    E.1.1.2Therapeutic area Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level LLT
    E.1.2Classification code 10029453
    E.1.2Term Nocturnal enuresis
    E.1.2System Organ Class 100000004857
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate the effect of melatonin in fixed dosage before bedtime in children with monosymtomatic nocturnal enuresis on the number of wet nights per week compared with placebo.
    At undersøge effekten af melatonin i fast dosering før sengetid hos børn med monosymtomatisk nocturn enuresis på antallet af våde nætter per uge sammenlignet med placebo.
    E.2.2Secondary objectives of the trial
    To investigate melatonins mechanisms of action in children with monosymptomatic nocturnal enuresis, including on nocturnal urine production, nocturnal blood pressure level and nocturnal bladder capacity.
    At undersøge virkningsmekanismerne bag melatonin hos børn med monosymptomatisk nocturn enuresis, herunder på natlig urinproduktion, natligt blodtryksniveau, og natlig blærekapacitet.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age 6-14 years

    - Clinical examination normal
    - ≥ 3 wet nights / week due to either nocturnal polyuria with normal bladder size or reduced daytime/nighttime bladder capacity with normal urine output
    -OR healthy control
    - Alder 6-14 år

    - Klinisk undersøgelse normal
    - ≥ 3 våde nætter/uge pga. enten natlig polyuri med normal blærestørrelse eller reduceret blærekapacitet med normal urinproduktion
    -ELLER rask kontrol
    E.4Principal exclusion criteria
    - Constipation (by ROME III criteria)
    - Day incontinence
    - Overactive bladder (ICCS 2008 classification of symptoms)
    - Current or past history of clinical or laboratory findings that can be related to diseases or conditions (eg pregnancy) likely to change the parameters examined, especially diseases of the kidney and urinary tract, liver or endocrine disorder.
    - Clinical signs of urinary tract infection
    - Hypertension, blood pressure assessed by ambulatory measurement with blood pressure cuff
    - Set treatment with one or more drugs
    -Obstipation (efter ROM III kriterier)
    -Daginkontinens
    -Overaktiv blære (ICCS 2008 klassifikation af symptomer)
    -Nuværende eller tidligere anamnestiske, kliniske eller laboratoriefund, der kan relateres til sygdomme eller tilstande (fx graviditet) der formodes at ændre de parametre der undersøges, specielt sygdomme i nyre og urinveje, lever eller endokrin lidelse.
    -Kliniske tegn på urinvejsinfektion
    -Hypertension, blodtryk bedømt ved ambulant måling med blodtryksmanchet
    -Fast behandling med et eller flere lægemidler
    E.5 End points
    E.5.1Primary end point(s)
    number of incontinence episodes
    antal af inkontinens episoder
    E.5.1.1Timepoint(s) of evaluation of this end point
    at the end of trial
    ved afslutning af forsøget
    E.5.2Secondary end point(s)
    nocturnal blood pressure, Circadian level (activity and skin), decrease in nocturnal urine production and increased bladder capacity
    natligt blodtryksfald, Døgnrytmeparametre (aktivitet- og hud-), fald i natlig urinproduktion samt øget blærekapacitet
    E.5.2.1Timepoint(s) of evaluation of this end point
    at the end of trial
    ved afslutning af forsøget
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    E.8.1.6Cross over Yes
    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 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
    Sidste besøg for sidste patient
    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 months8
    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: 40
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 40
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 40
    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 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 Yes
    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 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)
    after ended participation, the subject returns to the normal treatment in the outpatient clinic. If the subject has been recruited from a General Practitioner (GP), it will be discussed with the GP if the subject returns there for normal treatment or stays wirh the outpatient clinic at the hospital.
    Ved afslutning sendes forsøgspersonen til videre opfølgning og normal behandling i enuresisambulatoriet. Hvis patienten er rekrutteret fra egen læge, aftales det med denne om patienten følges op her eller i enuresisambulatoriet på hospitalet.
    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 Decision2011-12-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-10-26
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2019-05-06
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