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    The EU Clinical Trials Register currently displays   43974   clinical trials with a EudraCT protocol, of which   7312   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2017-000039-16
    Sponsor's Protocol Code Number:LUMC-PHEG-20172022
    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:2017-10-10
    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 number2017-000039-16
    A.3Full title of the trial
    Paracetamol to enhance quality of life and daily function and to decrease care dependency in advanced dementia: A randomized, double-blind, placebo-controlled crossover trial in long-term care facilities.
    Paracetamol ter verbetering van kwaliteit van leven en dagelijks functioneren en ter vermindering van zorgafhankelijkheid bij mensen met (ver)gevorderde dementie: een gerandomiseerde, dubbelblinde, placebo-gecontroleerde crossover studie in Nederlandse verpleeghuizen.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Paracetamol to enhance quality of life and daily function and to decrease care dependency in advanced dementia: A randomized, double-blind, placebo-controlled crossover trial in long-term care facilities.
    Paracetamol ter verbetering van kwaliteit van leven en dagelijks functioneren en ter vermindering van zorgafhankelijkheid bij mensen met (ver)gevorderde dementie: een gerandomiseerde, dubbelblinde, placebo-gecontroleerde crossover studie in Nederlandse verpleeghuizen.
    A.3.2Name or abbreviated title of the trial where available
    Quality of life and Paracetamol In advanced Dementia (Q-PID trial)
    Kwaliteit van leven en paracetamol bij mensen met matige tot (zeer) ernstige dementie (Q-PID-studie)
    A.4.1Sponsor's protocol code numberLUMC-PHEG-20172022
    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 SponsorLeiden University Medical Center
    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 supportZonMW
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLeiden University Medical Center
    B.5.2Functional name of contact pointQ-PID trial
    B.5.3 Address:
    B.5.3.1Street AddressAlbinusdreef 2 (V0-P)
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333 ZA
    B.5.3.4CountryNetherlands
    B.5.4Telephone number00310715268444
    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 Paracetamol
    D.2.1.1.2Name of the Marketing Authorisation holderTeva Nederland BV
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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.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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    We will investigate the effect of regularly scheduled administration of paracetamol on Quality of life, daily functioning, care dependency, pain, change in challenging behaviour and antipsychotic medication use of long term care facility residents with moderate to severe dementia (of all types).
    We zullen het effect van op vaste tijdstippen toedienen van paracetamol onderzoeken op kwaliteit van leven, dagelijks functioneren, zorgafhankelijkheid, pijn, verandering in onbegrepen gedrag en antipsychotica gebruik bij verpleeghuisbewoners met matige tot (zeer) ernstige dementie (alle vormen).
    E.1.1.1Medical condition in easily understood language
    Quality of life, daily functioning, care dependency, pain, change in challenging behaviour and antipsychotic medication use of long term care facility residents with moderate to severe dementia.
    Kwaliteit van leven, dagelijks functioneren, zorgafhankelijkheid, pijn, verandering in onbegrepen gedrag en antipsychotica gebruik bij verpleeghuisbewoners met matige tot (zeer) ernstige dementie.
    E.1.1.2Therapeutic area Not possible to specify
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10066844
    E.1.2Term Behavioral and psychiatric symptoms of dementia
    E.1.2System Organ Class 100000171288
    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 effect of regularly scheduled administration of paracetamol on quality of life of long term care facility residents with moderate to (very) severe dementia.
    Het onderzoeken van het effect van op een vast tijdstip toedienen van paracetamol op kwaliteit van leven van verpleeghuisbewoners met matige tot (zeer) ernstige dementie.
    E.2.2Secondary objectives of the trial
    To evaluate the effect of paracetamol treatment on daily function and care dependency, pain, change in challenging behaviour and antipsychotic medication use in long term care facility residents with moderate to (very) severe dementia.
    Het onderzoeken van het effect van paracetamol op dagelijks functioneren, zorgafhankelijkheid, pijn, verandering van onbegrepen gedrag en antipsychotica gebruik bij verpleeghuisbewoners met matige tot (zeer) ernstige dementie.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Diagnosis of dementia, Reisberg Global Deterioration Scale 5-7
    Age 65 years or older
    QUALIDEM (Quality of life) score below the expected median score of 70)
    Not using any pain medication one week before start study. Residents with PRN prescribed paracetamol ("as needed") are also eligible, if the use of paracetamol in the last week was less than 3 grams/week.
    Diagnose dementie volgens Reisberg Global Deterioration Scale 5-7
    Leeftijd 65 jaar en ouder
    QUALIDEM (Kwaliteit van leven) score onder de verwachte mediaanscore van 70
    Geen gebruik van pijnmedicatie minimaal één week voor start studie. Patiënten die zo nodig paracetamol gebruiken mogen meedoen, indien zij niet meer dan 3 gram per week gebruikten in de laatste week voor de studie.
    E.4Principal exclusion criteria
    • Presence of a severe psychiatric disorder
    • Severe liver insufficiency/disease
    • Use of >4 units alcohol per day
    • Allergy to study drugs
    • Concomitant use of flucloxacillin, carbamazepine, fenytoïne, fenobarbital, isoniazide and/or rifampicine
    • Weight <50 kg
    Aanwezigheid ernstige psychiatrische stoornis
    Ernstige leverinsufficiëntie/ziekte
    Gebruik van 4 of meer eenheden alcohol per dag
    Allergie voor studiemedicatie
    Gelijktijdig gebruik van flucloxacilline, carbamazepine, fenytoïne, fenobarbital, isoniazide en/of rifampicine
    Gewicht onder de 50 kg
    E.5 End points
    E.5.1Primary end point(s)
    Difference in baseline quality of life (QUALIDEM-score) and follow-up scores
    Verschil in baseline kwaliteit van leven (QUALIDEM) score en follow-up scores
    E.5.1.1Timepoint(s) of evaluation of this end point
    at Baseline
    at 6 weeks
    at 7 weeks
    at 13 weeks (end)
    op de baseline
    na 6 weken
    na 7 weken
    na 13 weken (einde)
    E.5.2Secondary end point(s)
    • Neuropsychiatric symptoms of dementia
    • ADL functioning
    • Care dependency
    • Dementia severity
    • Pain
    • Medication use
    All measurements above will be taken at baseline and compared with follow-up scores
    Neuropsychiatrische symptomen dementie
    Dagelijks functioneren
    Zorgafhankelijkheid
    Ernst dementie
    Pijn
    (Antipsychotische) medicatie gebruik
    Alle metingen hierboven zullen op baseline worden gemeten en vergeleken worden met follow-up scores na 6, 7 en 13 weken.
    E.5.2.1Timepoint(s) of evaluation of this end point
    at Baseline
    at 6 weeks
    at 7 weeks
    at 13 weeks (end)
    op de baseline
    na 6 weken
    na 7 weken
    na 13 weken (einde)
    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 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 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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    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: 95
    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
    Long term care facility residents with moderate to (very) severe dementia
    Verpleeghuisbewoners met matige tot (zeer) ernstige dementie
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state95
    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
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation University Network for Care sector Zuid-Holland (UNC-ZH)
    G.4.3.4Network Country Netherlands
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-10-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-10-10
    P. End of Trial
    P.End of Trial StatusOngoing
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