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    Summary
    EudraCT Number:2016-002287-14
    Sponsor's Protocol Code Number:Reutelen
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-11-17
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2016-002287-14
    A.3Full title of the trial
    Death rattle in the dying phase: is prophylactic treatment useful?
    Reutelen in de stervensfase: is profylactische behandeling zinvol?
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Death rattle
    Reutelen
    A.3.2Name or abbreviated title of the trial where available
    Reutelen
    A.4.1Sponsor's protocol code numberReutelen
    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 SponsorErasmus MC Cancer Institute
    B.1.3.4CountryNetherlands
    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 supportErasmus MC
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportZonMW/ Palliantie
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationErasmus MC Cancer Institute
    B.5.2Functional name of contact pointC. van Zuylen
    B.5.3 Address:
    B.5.3.1Street Address's Gravendijkwal 230
    B.5.3.2Town/ cityRotterdam
    B.5.3.3Post code3015 CE
    B.5.3.4CountryNetherlands
    B.5.6E-mailc.vanzuylen@erasmusmc.nl
    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 No
    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 namescopolaminebutyl
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNbutylscopolaminebromide
    D.3.9.1CAS number 149-64-4
    D.3.9.3Other descriptive nameHYOSCINE BUTYLBROMIDE
    D.3.9.4EV Substance CodeSUB14154MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Death rattle in the dying phase
    Reutelen in de stervensfase
    E.1.1.1Medical condition in easily understood language
    Death rattle in the dying phase
    Reutelen in de stervensfase
    E.1.1.2Therapeutic area Body processes [G] - Physiological processes [G07]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10031920
    E.1.2Term Other diseases of trachea and bronchus, not elsewhere classified
    E.1.2System Organ Class 100000004855
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Can administration of scopolaminebutyl from the start of the dying phase prevent death rattle during the dying phase?
    Kan toediening van scopolaminebutyl vanaf de start van de stervensfase reutelen tijdens de stervensfase voorkomen?
    E.2.2Secondary objectives of the trial
    Is the appearance of death rattle delayed by preventive administration of hyoscine butylbromide (HB)
    Does preventive administration of HB from the recognition of the dying phase induce side-effects as micturition, dry mouth and restlessness
    Is there:
    -a difference in the quality of death among patients treated with HB and placebo, according to survivors and caregivers
    -a difference in quality of life the last three days of the patient, according to the relatives and caregivers
    -a difference in quality of care during a stay and in the past three days between patients treated with HB and placebo, according to survivors
    -a difference in the way of death according to the relatives and caregivers
    -a difference in the moment of death, according to the survivors and the caregivers
    -a difference between the mourning relatives of patients treated with placebo and HB
    Which influence has participation in the study on the quality of death of the patient, according to survivors
    Wordt het optreden van reutelen uitgesteld door preventieve toediening van scopolaminebutyl (SB)
    Veroorzaakt preventieve toediening van SB vanaf de herkenning van de stervensfase bijwerkingen, te weten, mictieproblemen, droge mond en onrust
    Is er verschil:
    -in de kwaliteit van sterven tussen de patiënten die behandeld worden met SB en placebo, volgens nabestaanden en zorgverleners
    -in kwaliteit van leven de laatste 3 dagen van de patiënt, volgens de nabestaanden en de zorgverleners
    -van kwaliteit van zorg tijdens verblijf en gedurende de laatste 3 dagen tussen de patiënten die behandeld worden met SB en placebo, volgens nabestaanden
    -in de manier van sterven volgens de nabestaanden en de zorgverleners
    -in het moment van sterven volgens de nabestaanden en de zorgverleners
    -in de rouwverwerking tussen nabestaanden van patiënten die behandeld worden met SB en placebo
    Welke invloed heeft deelname aan het onderzoek op de kwaliteit van sterven van de patiënt, volgens nabestaanden
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Admission for care and treatment in one of the participating hospice facilities
    2. It is known by the patient and his/her relatives that the admission will be up to death
    3. At admission life expectancy is at least 3 days
    4. At explanation of the study (shortly after admission to hospice facility) and signing of the informed consent the patient is conscious
    5. Presence of a signed informed consent
    1. Opname voor zorg en behandeling in een van de deelnemende hospicevoorzieningen
    2. Bij de patiënt en diens naasten is bekend dat het gaat om opname tot overlijden
    3. Bij opname is sprake van een levensverwachting van minimaal 3 dagen
    4. Er is een helder bewustzijn op moment van uitleg over studie (kort na opname in hospicevoorziening) en tekenen informed consent
    5. Aanwezigheid van een getekend informed consent
    E.4Principal exclusion criteria
    1. There are signs of a respiratory infection (upper or lower
    respiratory tract)
    2. The patient has a tracheostomy or tracheocanula
    3. The patient uses an anticholinergic or octreotide
    4. At the start/At recognition of the dying phase death rattle is present at grade 1 or more, according to Back
    1. Er zijn tekenen van actieve luchtweginfectie (van bovenste of lage luchtwegen)
    2. De patiënt heeft een tracheostoma of-canule
    3. De patiënt gebruikt een anticholinergicum of octreotide
    4. Bij ingaan van de stervensfase is sprake van reutelen graad 1 of meer, volgens de gradering van Back
    E.5 End points
    E.5.1Primary end point(s)
    The percentage of patients who develop death rattle, defined as the appearance of grade 2 or higher according to the method of Back measured at 2 successive times/time points with an interval of 4 hours.
    The following degrees of rattle are distinguished:
    grade 0 = no audible rattle
    grade 1 = rattle only audible close to the patient
    grade 2 = rattle in a quiet room clearly audible at the foot of the bed
    grade 3 = rattle in a quiet room audible at a distance of 10 meters (at the door of a room)
    Het percentage patiënten die reutelen, gedefinieerd als het optreden van reutelen graad 2 of meer volgens de gradering van Back op 2 opvolgende meetpunten met een tussenpoos van vier uur.
    De gradering van Back onderscheidt de volgende graden van reutelen:
    graad 0 = geen hoorbaar reutelen
    graad 1 = reutelen alleen hoorbaar dicht bij de patiënt
    graad 2 = reutelen in een stille kamer duidelijk hoorbaar bij het voeteneind van het bed
    graad 3 = reutelen in een stille kamer duidelijk hoorbaar op een afstand van 10 meter (bij de deur van een kamer)
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of study
    Einde van de studie
    E.5.2Secondary end point(s)
    - Time from recognition of the dying phase until death rattle
    - Appearance of the adverse events micturition, dry mouth and restlessness by observations noted in the digital Care plan of the dying (formerly known as Liverpool Care Pathway)
    - Quality of life during the last three days of the life of the patient, according to the
    caregiver, indicated by a numerical value on a scale of 0 to 10 (0 = no quality; 10 = the best quality that can be imagined)
    - Quality of dying of the patient, according to the caregiver, indicated by a numerical value on a scale of 0 to 10 (0 =no quality; 10 = the best quality that can be imagined )
    - Manner of death, according to the caregiver, indicated with 15 qualitative terms.
    - Moment of death, according to the caregiver, indicated with 15 qualitative terms.
    - Quality of Life in the last three days of the patient according to the relatives, indicated with a numerical value on a scale of 0 to 10 (0 =no quality; 10 = the best quality that can be imagined )
    - Quality of dying of the patient, indicated by the relatives, indicated with a numerical value on a scale of 0 to 10 (0 = no quality; 10 = the best quality that can be imagined )
    - The way of dying, according to the relatives, indicated with 15 qualitative terms.
    - Moment of death, according to the relatives, indicated with 15 qualitative terms.
    - Extent of bereavement for relatives according to the Leiden Score (15)
    - Experience of participating in a (double-blind, placebo-controlled) scientific research trial through a questionnaire with questions about the perception and the meaning of participating in a trial indicated by a numerical value on a scale of 1 to 4 (1 = no stress; 4 = extremely stressful)
    - Tijd vanaf herkenning stervensfase tot aan optreden reutelen
    - Optreden van de bijwerkingen mictieproblemen, droge mond en onrust via observaties vastgelegd in het digitale Zorgpad Stervensfase (ZSD)
    - Kwaliteit van leven de laatste drie dagen van de patiënt volgens de zorgverleners weergegeven met een numerieke waarde op een schaal van 0 tot 10 (0= geen kwaliteit; 10=de beste kwaliteit die men zich kan voorstellen)
    - Kwaliteit van sterven van de patiënt volgens de zorgverleners weergegeven met een numerieke waarde op een schaal van 0 tot 10 (0= geen kwaliteit; 10=de beste kwaliteit die men zich kan voorstellen)
    - Manier van overlijden volgens de zorgverleners weergegeven volgens 15 kwalitatieve termen
    - Moment van overlijden volgens de zorg weergegeven volgens 15 kwalitatieve termen
    - Kwaliteit van leven de laatste drie dagen van de patiënt volgens de nabestaanden weergegeven met een numerieke waarde op een schaal van 0 tot 10 (0= geen kwaliteit; 10=de beste kwaliteit die men zich kan voorstellen)
    - Kwaliteit van sterven van de patiënt volgens nabestaanden weergegeven met een numerieke waarde op een schaal van 0 tot 10 (0= geen kwaliteit; 10=de beste kwaliteit die men zich kan voorstellen)
    - Kwaliteit van zorg gedurende verblijf hospice volgens nabestaanden weergegeven met een numerieke waarde op een schaal van 0 tot 10 (0= geen kwaliteit; 10=de beste kwaliteit die men zich kan voorstellen)
    - Kwaliteit van zorg gedurende de laatste drie dagen volgens nabestaanden weergegeven met een numerieke waarde op een schaal van 0 tot 10 (0= geen kwaliteit; 10=de beste kwaliteit die men zich kan voorstellen)
    - Manier van overlijden volgens de nabestaanden weergegeven volgens 15 kwalitatieve termen
    - Moment van overlijden volgens de nabestaanden weergegeven volgens 15 kwalitatieve termen
    - Mate van rouwverwerking bij nabestaanden volgens de Leidenscore (15)
    E.5.2.1Timepoint(s) of evaluation of this end point
    End of study
    Einde van de studie
    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 Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 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 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 concerned4
    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
    overlijden na stervensfase laatste 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 months6
    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) Yes
    F.1.2.1Number of subjects for this age range: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 150
    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 No
    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 No
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Subjects hospitalized in hospice with a life expectancy of three months or shorter
    Patienten opgenomen in hospice met een levensverwachting < 3 mnd
    F.4 Planned number of subjects to be included
    F.4.1In the member state200
    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
    geen
    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 Decision2016-11-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-12-23
    P. End of Trial
    P.End of Trial StatusOngoing
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