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    Summary
    EudraCT Number:2012-004354-28
    Sponsor's Protocol Code Number:S-20120017
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-07-02
    Trial 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 number2012-004354-28
    A.3Full title of the trial
    Maintenance treatment in childhood constipation.
    A randomized placebo-controlled intervention study
    Vedligeholdelsesbehandling ved simpel obstipation.
    Et randomiseret placebo kontrolleret interventionsstudie.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment of childhood conspitaion.
    Behandling af børn med forstoppelse.
    A.4.1Sponsor's protocol code numberS-20120017
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01566409
    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 SponsorBørneafdelingen Kolding
    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 supportBørneafdelingen Kolding
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportRegion syddanmark
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportSyddansk universitet
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportNorgine Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBørneafdelingen Kolding
    B.5.2Functional name of contact pointNCT01566409
    B.5.3 Address:
    B.5.3.1Street AddressSkovvangen 2-8
    B.5.3.2Town/ cityKolding
    B.5.3.3Post code6000
    B.5.3.4CountryDenmark
    B.5.4Telephone number004576362254
    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 MOVICOL Lemon and Lime
    D.2.1.1.2Name of the Marketing Authorisation holderNorgine 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.3.4Pharmaceutical form Powder for oral solution
    D.3.4.1Specific paediatric formulation Yes
    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 placeboPowder for oral solution
    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
    Childhood functional constipation.
    Kronisk forstoppelse hos børn.
    E.1.1.1Medical condition in easily understood language
    Childhood functional constipation.
    Kronisk forstoppelse hos børn.
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    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 purpose of the study is to investigate the effect of maintenance treatment with macrogol 3350 + electrolytes (PEG 3350 + E) in the treatment of childhood constipation in a randomized, placebo-controlled design.
    Formålet med studiet er at undersøge effekten af vedligeholdelsesbehandling med polyethylen glycol 3350 (PEG) til børn med simpel obstipation i et randomiseret, dobbeltblindet, placebokontrolleret design.
    E.2.2Secondary objectives of the trial
    - Consumption of study medication.
    - Number of re-constipated children who need to switch to active treatment.
    - Changes in stool frequency, fecal incontinence episodes and abdominal pain.
    •Forbrug af studiemedicin.
    •Behov for skift til åben aktiv behandling med PEG.
    •Ændring i afføringsfrekvens, antal af inkontinensepisoder og antal mavesmerter per uge.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Referred children to the pediatric out patient clinic with either constipation or fecal incontinence, age 2 to 16 years.

    • Children must meet the ROME III criteria. This means that children below 4 years must meet at least 2 of the following criteria during a month, children above 4 years must meet at least 2 of the criteria at least once a week for 2 months:
    • Two or fewer bowel movements weekly.
    • More than one episode of fecal incontinence weekly.
    • Painful defecation.
    • Occasional passage of large stools.
    • Display of retentive posturing and withholding behavior.
    • Large stools in the rectum identified by digital examination or palpable on abdominal examination.
    Rome III criteria is developed by scientists and widely internationally accepted among research in childhood constipation.
    Børn henvist til børneafdelingen med obstipation mellem 2 og 16 år.
    Børnene skal opfylde ROME III kriterierne for funktionel forstoppelse:
    ROME III kriterierne
    Børn under 4 år skal opfylde minimum 2 af nedenstående kriterier igennem en måned, børn over 4 år skal opfylde minimum 2 af kriterierne mindst én gang om ugen igennem 2 måneder.
    • To eller færre afføringer/uge.
    • Fækal inkontinens mere end en gang om ugen.
    • Smertefuld defækation.
    • Passage af store mængder afføring der kan obstruere toilettet.
    • Adfærd med tilbageholdelse af afføring.
    • Stor mængde fæces i ampullen ved rektaleksploration.
    Rome III kriternerne er internationalt udviklede og accepterede kriterier mhp. at opnå sammenlignelige studier af bl.a. obstipation hos børn.
    E.4Principal exclusion criteria
    Children not eligible for participation is children who receive treatment with medications known to affect bowel function, apart from laxatives, within a 2-month period and children e.g. with known organic causes of constipation including Hirschsprung disease, previous surgery on the colon or inflammatory bowel disease.
    Barnet kan ikke inkluderes, hvis det er i behandling med medicin som er kendt for at påvirke tarmfunktionen, fraset laksantia, inden for en 2 måneders periode, eller hvis barnet lider af anden gastrointestinal sygdom som f.eks. mb. Hirschsprung, tidligere operation på colon eller inflammatorisk tarmsygdom.
    E.5 End points
    E.5.1Primary end point(s)
    Treatment effect.
    Treatment effect is defined as absence or continued presence of symptoms of constipation based on the Rome III criteria with or without medication. Primaty outcom is calculated in an intention to treat analysis-
    Behandlingseffekt.
    Behandlingseffekten defineres som fravær eller fortsat tilstedeværelse af symptomer på simpel obstipation vurderet ud fra ROME III kriterierne sammenholdt med behovet for medicin.
    Primært outcome beregnes i en intention to treat analyse.
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months after inclusion
    6 måneder efter inklusion
    E.5.2Secondary end point(s)
    - Consumption of study medication.
    - Number of re-constipated children who need to switch to active treatment.
    - Changes in stool frequency, fecal incontinence episodes and abdominal pain.

    •Forbrug af studiemedicin.
    •Behov for skift til åben aktiv behandling med PEG.
    •Ændring i afføringsfrekvens, antal af inkontinensepisoder og antal mavesmerter per uge.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Consumption of study medication will be evaluated at each visit and at the end of the trial.
    - Number of re-constipated children who need to switch to active treatment will be evaluated at each visit and at the end of the trial.
    - Changes in stool frequency, fecal incontinence episodes and abdominal pain will be evaluated at each visit and at the end of the trial.
    •Forbrug af studiemedicin vil blive opgjort ved hver kontakt og ved studiets afslutning.
    •Behov for skift til åben aktiv behandling med PEG vil blive opgjort ved hver kontakt og ved studiets afslutning.
    •Ændring i afføringsfrekvens, antal af inkontinensepisoder og antal mavesmerter per uge vil blive opgjort ved hver kontakt og ved studiets afslutning.
    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 No
    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 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 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 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
    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 months6
    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: 125
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 100
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 25
    F.1.2Adults (18-64 years) No
    F.1.2.1Number of subjects for this age range: 0
    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 Yes
    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 state125
    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 child will be released for general treatment in the pediatric outpatient clinic if there is a need for this after the study has ended.
    Barnet vil overgå til almindelig behandlig i børneambulatoriet hvis der er behov for dette efter studiets ophør.
    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 Decision2013-07-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-03-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-09-24
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