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    Summary
    EudraCT Number:2019-000203-33
    Sponsor's Protocol Code Number:9119
    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:2019-07-04
    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 number2019-000203-33
    A.3Full title of the trial
    Paracetamol Discontinuation in the Elderly after long-term consumption (PARADISE)
    Ophør af paracetamol anvendt som langtidsbehandling hos patienter på 65 år og derover.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Paracetamol Discontinuation in the Elderly after long-term consumption (PARADISE)
    Ophør af paracetamol anvendt som langtidsbehandling hos patienter på 65 år og derover.
    A.3.2Name or abbreviated title of the trial where available
    PARADISE
    A.4.1Sponsor's protocol code number9119
    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 SponsorKlinisk Farmakologisk Afdeling
    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 supportKlinisk Farmakologisk Afdeling Bispebjerg Hospital
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKlinisk Farmakologisk Afdeling
    B.5.2Functional name of contact pointLykke Ida Kaas-Rasmussen Olsen
    B.5.3 Address:
    B.5.3.1Street AddressBispebjerg Bakke 23
    B.5.3.2Town/ cityKøbenhavn NV
    B.5.3.3Post code2400
    B.5.3.4CountryDenmark
    B.5.4Telephone number+4538635148
    B.5.6E-maillykke.ida.kaas-rasmussen.olsen.01@regionh.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 Arax
    D.2.1.1.2Name of the Marketing Authorisation holder Vitabalans Oy
    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.3.1Product nameParacetamol
    D.3.4Pharmaceutical form Tablet
    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 INNParacetamol
    D.3.9.3Other descriptive namePARACETAMOL
    D.3.9.4EV Substance CodeSUB09611MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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
    E.1.1.1Medical condition in easily understood language
    chronical pain (or simply long-term consumers of pain killers)
    E.1.1.2Therapeutic area Not possible to specify
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10049475
    E.1.2Term Chronic pain
    E.1.2System Organ Class 100000004867
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Overall, this trial is conducted to investigate if paracetamol used as long-term treatment can be discontinued without changes in pain conditions, level of function, and quality of life. Assessment of the effects of paracetamol during long-term treatment will indicate if this treatment is rational or not.

    The objective of study 1 is to investigate the impact of discontinuing a long-term paracetamol treatment in elderly patients by performing a randomized controlled trial where paracetamol will be discontinued. This will mainly be assessed by investigating the progress of pain condition during the treatment period as well as the health-related quality of life and level of function.

    E.2.2Secondary objectives of the trial
    The objectives of study 2 are to evaluate the participants’ need for paracetamol after ending the treatment period and after unblinding of the participants.
    This is done by reviewing the participants consumption of paracetamol, changes in other analgesics, and if there are any consequences of paracetamol discontinuation, such as an increase in falling accidents and hospitalizations.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    a. Inclusion criteria
    Patients aged 65 years or above, who for at least 6 months prior to enrollment have received paracetamol as prescribed daily regular medication of 3 to 4 grams.
    E.4Principal exclusion criteria
    b. Exclusion criteria
     Malignant pain cf. their medical records
     Patients using other regular analgesics
     Patients receiving paracetamol tablets with modified release or sustained release
     Patients in warfarin treatment
     Patients with terminal illnesses, cf. their medical records.
     Patients receiving dosages dispensed by their pharmacy
     MMSE score less than 25
    E.5 End points
    E.5.1Primary end point(s)
    Endpoints for study 1
    Primary
    Visual analog scale (VAS) pain intensity

    Endpoints for study 2
    Primary
    Number of regular users (3 grams of paracetamol or more) since ending treatment period.
    E.5.1.1Timepoint(s) of evaluation of this end point
    When trial period for study 1 is over for all participants the data will be analysed and endpoints evaluated.
    E.5.2Secondary end point(s)
    For study 1:
    Secondary
    The European Quality of Life-5 Dimensions Index (EQ-5D-5L)
    Treatment failure. Defined as initiating other regular analgesics; or withdrawal.
    Functional test: 6-meter walking test, grip strength, and sitting-rising test

    For study 2:
    Secondary
    VAS pain intensity
    EQ-5D-5L
    Treatment failure: Number of participants who initiated regular use of other analgesics

    E.5.2.1Timepoint(s) of evaluation of this end point
    When trial period for study 2 is over for all participants the data will be analysed and endpoints evaluated.
    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 Yes
    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 concerned2
    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 years2
    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) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 132
    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 No
    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 state132
    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 Decision2019-07-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-10-16
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2023-03-15
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