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    Summary
    EudraCT Number:2014-004899-35
    Sponsor's Protocol Code Number:MORDYC
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-01-15
    Trial results View 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 number2014-004899-35
    A.3Full title of the trial
    Morphine for palliative treatment of refractory dyspnea in patients with advanced COPD: benefits and respiratory adverse effects
    Palliatieve behandeling van refractaire dyspnoe bij patiënten met gevorderd COPD: voordelen en respiratoire nevenwerkingen
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment of breathlessness with morphine in patients with COPD: benefits and safety
    Behandeling van kortademigheid met morfine bij patiënten met COPD: effecten en veiligheid
    A.3.2Name or abbreviated title of the trial where available
    MORDYC
    A.4.1Sponsor's protocol code numberMORDYC
    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 SponsorMaastricht University
    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 organisationCentre of expertise for palliative care, Maastricht UMC+
    B.5.2Functional name of contact pointD. Janssen
    B.5.3 Address:
    B.5.3.1Street AddressP. Debyelaan 25
    B.5.3.2Town/ cityMaastricht
    B.5.3.3Post code6229HX
    B.5.3.4CountryNetherlands
    B.5.6E-maildaisy.janssen@mumc.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 Yes
    D.2.1.1.1Trade name Morfine HCl retard CF 10 mg
    D.2.1.1.2Name of the Marketing Authorisation holderCentrafarm B.V., Etten-Leur, The Netherlands
    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.3.1Product nameMorfine HCl retard CF 10 mg
    D.3.2Product code RVG 22941
    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 placeboCapsule, hard
    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
    Chronic Obstructive Pulmonary Disease
    Chronisch obstructieve longziekten
    E.1.1.1Medical condition in easily understood language
    COPD
    COPD
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level LLT
    E.1.2Classification code 10010952
    E.1.2Term COPD
    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
    1.1) to study whether and to what extent oral administration of morphine SR improves health-related quality of life among patients with advanced COPD;
    1.2) to explore whether and to what extent oral administration of morphine SR leads to adverse respiratory effects in patients with advanced COPD.
    E.2.2Secondary objectives of the trial
    2.1) to study whether and to what extent oral administration of morphine SR improves exercise capacity among patients with advanced COPD;
    2.2) to study the relationship between severity and description of breathlessness and response to morphine SR among patients with advanced COPD;
    2.3) to analyse the cost-effectives of oral administration of morphine SR in patients with advanced COPD.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • diagnosis of COPD according to the current Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease (GOLD) ;
    • optimal pharmacological treatment;
    • Grade 3 or 4 dyspnea on the mMRC;
    • optimal non-pharmacological treatment defined as completed a comprehensive pulmonary rehabilitation program.
    E.4Principal exclusion criteria
    • history of substance misuse;
    • exacerbation of COPD within two weeks of study enrolment;
    • waiting list for lung transplantation;
    • pregnant or childbearing potential not using contraception;

    • renal failure (creatinine clearance <15mL/min);
    • age under 18;

    • not being able to read or fill in the questionnaires
or diary;
    • allergy for morphine or its excipients;

    • concomitant use of irreversible MAO blockers;

    • use of opioids.
    E.5 End points
    E.5.1Primary end point(s)
    • Change in disease-specific health-related quality of life (COPD Assessment Test (CAT);
    • Change in respiratory parameters: arterial blood gas (partial pressure of carbon dioxide (pCO2); partial pressure of oxygen (pO2); respiratory rate; pulse oximetric saturation (SpO2); transcutaneous carbon dioxide (PtcCO2); Overnight oximetry; lung function.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline, 1, 2 and 4 weeks
    E.5.2Secondary end point(s)
    • Change in exercise capacity (6 minute walking distance test);
    • Change in functional capacity (care dependency (Care Dependency Scale) and mobility (Timed ‘Up & Go’ test).
    • sensory and affective dimensions of dyspnea (Multidimensional Dyspnea Profile);
    • impact of dyspnea (modified Pulmonary Functional Status and Dyspnea Questionnaire);
    • dyspnea (Numeric Rating Scale)
    • adverse affects (including nausea, vomiting, constipation, and drowsiness)
    • compliance;
    • exacerbations (defined as an acute event characterized by a worsening of the patient’s respiratory symptoms that is beyond normal day-to-day variations and leads to a change in medication).
    • Costs and cost-effectiveness
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline, 1, 2 and 4 weeks
    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 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) 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 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 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.

    Criteria for termination of the study prematurely:
    • Statistically significant higher proportion of deceased patients in the intervention group;
    • Statistically significant higher proportion of hospitalized patients in the intervention group.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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) Yes
    F.1.2.1Number of subjects for this age range: 70
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 No
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Patients with advanced chronic and life-limiting disease
    F.4 Planned number of subjects to be included
    F.4.1In the member state120
    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)
    Patients will receive usual care after the subject has ended the participation in the trial. If patients prefer, they will be prescribed morphine by a palliative care consultant in collaboration with their general practitioner.
    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 Decision2015-01-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-04-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-07-01
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