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    Summary
    EudraCT Number:2019-003850-10
    Sponsor's Protocol Code Number:Laxatives26.09.2019
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-12-12
    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 number2019-003850-10
    A.3Full title of the trial
    Oral laxatives after hip fracture surgery: A randomised controlled trial.
    Oral laksantia efter hoftenære frakturer: Et randomiseret kontrolleret studie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    What laxative after hip surgery?
    Hvilket afføringsmiddel efter hofteoperation?
    A.4.1Sponsor's protocol code numberLaxatives26.09.2019
    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 SponsorHospital Pharmacy Funen, Research Department, Odense University Hospital
    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 supportOdense University Hospital Free Reseach Fund
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital Pharmacy Funen, Odense University Hospital
    B.5.2Functional name of contact pointResearch Department
    B.5.3 Address:
    B.5.3.1Street AddressSolfaldsvej 38
    B.5.3.2Town/ cityOdense
    B.5.3.3Post code5000
    B.5.3.4CountryDenmark
    B.5.6E-maillene.ravn-nielsen@rsyd.dk
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 Magnesia "Medic"
    D.2.1.1.2Name of the Marketing Authorisation holderMylan
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 Tablet
    D.3.4.1Specific paediatric formulation No
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Gangiden
    D.2.1.1.2Name of the Marketing Authorisation holderSandoz
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 in sachet
    D.3.4.1Specific paediatric formulation No
    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 placeboTablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboPowder for oral solution in sachet
    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
    The aim is to investigate which constipation therapy is the most optimal choice for postoperative treatment in older patients after hip fracture surgery compared to placebo.
    Formålet er at vise om der er en klinisk relevant effekt af to regimer af obstipationsbehandling efter hoftefrakturoperation, sammenlignet med placebo.
    E.1.1.1Medical condition in easily understood language
    Constipation after hip fracture surgery
    Forstoppelse efter operation af hoftebrud
    E.1.1.2Therapeutic area Diseases [C] - Injuries, poisonings, and occupational diseases [C21]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level PT
    E.1.2Classification code 10020100
    E.1.2Term Hip fracture
    E.1.2System Organ Class 10022117 - Injury, poisoning and procedural complications
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The aim of this double-blinded randomized controlled study is to investigate which constipation therapy is the most optimal choice for postoperative treatment in older patients after hip fracture surgery compared to placebo.
    Formålet med dette projekt er i et randomiseret placebokontrolleret studie at vise om der er en klinisk relevant effekt af to regimer af obstipationsbehandling efter hoftefrakturoperation, sammenlignet med placebo.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Hip fracture patients, age≥ 65 year will be included from three orthopedic departments from hospitals in the Southern Region of Denmark. The patients should be able to speak and understand Danish.

    Pregnant women can not be included but the women are expected to be postmenopausale why pregnancy test are not performed.
    •Alle pt. med hoftenære frakturer i alderen 65 +, der indlægges via Fælles Akutmodtagelsen (FAM) eller får akut hoftenær fraktur under deres indlæggelse og skal opereres
    •Tale og forstå dansk
    •Være i stand til selv at give informeret samtykke

    Gravide må ikke indgå i projektet, men da alle forsøgspersonerne er over 65 år forventes det, at kvinderne er postmenopausale, hvorfor der ikke foretages graviditetstest.
    E.4Principal exclusion criteria
    Patients:
    • with known cronic constipation (defined from Wexner constipation score)
    • with known use of laxatives at admission
    • who participate in other similar clinical studies
    • who is terminally ill
    • who is restraint
    • who is in isolation
    • with severe heart disease defined as NYHA III og IV
    • with eGFR < 30 ml/min.
    • Allergies to the ingredients
    Patienter:
    •med kendt kronisk obstipation (defineret ud fra Wexner obstipations score)
    •med kendt brug af laksantia ved indlæggelse
    •som deltager i andre lignende kliniske studier
    •som er terminalerklærede
    •som er frihedsberøvede
    •som er isolerede
    •med svær hjertesygdom defineret som NYHA III og IV
    •med eGFR < 30 ml/min.
    •CAVE over for indholdsstofferne
    E.5 End points
    E.5.1Primary end point(s)
    Part of patients in each group who needs recue medication after 72 hours or rescue medication before 72 hours on behalf of a medical assessment
    Andel af patienter i hver gruppe, som skal have rescue-medicin 72 timer efter operation eller skal have rescue-medicin før 72 timer fra operation på baggrund af en klinisk lægelig vurdering?
    E.5.1.1Timepoint(s) of evaluation of this end point
    Hours after end surgery
    Timer efter afsluttet operation
    E.5.2Secondary end point(s)
    Time to first bowel movements (in hours after finished surgery)
    Length of hospital stay
    Risk of readmission at hospital (part of patients who are readmitted at hospital)
    Adverse reactions: Nausea, pain (by use of visual analoque scale), flatulence, diarrhea/constipation defined from fra Bristol Stool Scale Constipation score: Patient Assessment of Constipation symptoms Questionaire
    part of patients with need of rescue medication within the first 72 hours from surgery
    • Tid til første afføring (målt i timer efter afsluttet operation)
    • Antal indlæggelsesdage for inklusionsindlæggelsen
    • Risiko for genindlæggelse (hvor stor en andel patienter, der indlægges igen)
    • Bivirkninger: Kvalme, smerte (fx ved brug af VAS-skala), flatulens, diarré/obstipation, defineret ud fra Bristol Stool Scale
    • Obstipation score: Patient Assessment of Constipation symptoms
    •Andel af patienter i hver gruppe med behov for”rescue medication” - tillæg af laksantia i løbet af de første 72 timer efter operation
    E.5.2.1Timepoint(s) of evaluation of this end point
    30 days and 90 days
    30 dage og 90 dage
    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 trial3
    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 concerned6
    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 years
    E.8.9.1In the Member State concerned months19
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 834
    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 state834
    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 Decision2020-02-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-11-13
    P. End of Trial
    P.End of Trial StatusOngoing
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