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    Summary
    EudraCT Number:2021-003427-14
    Sponsor's Protocol Code Number:AHUS_PAL_21_01
    National Competent Authority:Norway - NOMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-11-01
    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 ConcernedNorway - NOMA
    A.2EudraCT number2021-003427-14
    A.3Full title of the trial
    A randomized controlled trial of subcutaneous versus intravenous morphine when switching from oral to parenteral route in palliative cancer patients
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Subcutaneous verus intravenous morphine in palliative cancer patients
    A.4.1Sponsor's protocol code numberAHUS_PAL_21_01
    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 SponsorAkershus University Hospital
    B.1.3.4CountryNorway
    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 supportSouth-Eastern Norway Regional Health Authority
    B.4.2CountryNorway
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAkershus University Hospital
    B.5.2Functional name of contact pointPrincipal investigator
    B.5.3 Address:
    B.5.3.1Street AddressSykehusveien 25
    B.5.3.2Town/ cityLørenskog
    B.5.3.3Post code1478
    B.5.3.4CountryNorway
    B.5.4Telephone number4746808581
    B.5.6E-mailolav.magnus.fredheim@ahus.no
    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 Morphine Orifarm Healthcare 20 mg/ml inj or 10 mg/ml inj.
    D.2.1.1.2Name of the Marketing Authorisation holderOrifarm Healthcare
    D.2.1.2Country which granted the Marketing AuthorisationNorway
    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 nameMorphine
    D.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    Subcutaneous 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 placeboSolution for injection/infusion
    D.8.4Route of administration of the placeboParenteral use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Cancer pain not responding to oral opioids in palliative cancer patient, where switching to the parenteral route is indicated.
    E.1.1.1Medical condition in easily understood language
    Pain from cancer disease in patients with incurable cancer. The pain has not responded to treatment with opioid tablets.
    E.1.1.2Therapeutic area Diseases [C] - Symptoms and general pathology [C23]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The overall objective is to establish whether either the intravenous or subcutaneous route of administration has clinically significant advantages when parenteral administration or morphine is started with a combination of continuous infusion and bolus doses in palliative cancer patients.

    Primary research question:
    • Is there a difference between s.c. and i.v. administration of morphine in how quickly pain control is achieved after initiation of a continuous infusion?
    E.2.2Secondary objectives of the trial
    Secondary research questions:
    • Is there a clinically significant difference between s.c. and i.v. administration of morphine in time from administration of bolus dose to clinically significant pain relief?
    • How large is the difference in the key pharmacokinetic parameters Tmax, Cmax, and AUC0-60 after s.c. and i.v. administration of morphine bolus doses during morphine infusion in palliative cancer patients?
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    All of the following conditions must apply to the prospective patient at screening prior to receiving study agent:
    • Unsatisfactory pain control despite titration of oral or transdermal opioids
    • Planned discharge to home or nursing home
    • The physician considers the appropriate starting dose to be either morphine 5 mg/ml with infusion rate 0.2 to 0.8 ml/h or morphine 10 mg/ml with infusion rate 0.2 to 0.8 ml/h.
    • Signed informed consent from the patient
    • Patient available for admission to Department of Palliative Medicine in time to start infusion between 11 am and 3 pm
    E.4Principal exclusion criteria
    • A clear indication for either intravenous or subcutaneous administration (by consensus of two senior consultants in palliative medicine)
    • Patient unable to report patient reported outcomes needed in the study due to language barriers, cognitive impairment, or delirium.
    • Impossible to establish venous access
    • Allergy or previous serious adverse effects from morphine
    • Opioid treatments other than oral/parenteral morphine, oral/parenteral oxycodone and transdermal/transmucosal fentanyl.
    • Contraindications to use of morphine.
    - Severe renal failure (estimated glomerular filtration rate < 30 based on kreatinin)
    • Strong indication for start of morphine infusion outside of the time interval of 11 am to 3 pm
    • Estimated survival time <2 weeks based on clinical judgement (by consensus of two senior consultants in palliative medicine)
    • Severe cachecia or peripheral edemas which are relative contraindications to the subcutaneous route of administration (clinical judgement by the responsible physician)

    Patients with Hb <9 g/dL (7.0 – 9.9 g/dL is considered moderate anemia) will not be included in the pharmacokinetic analyses because it can not be ruled out that the loss of 100-150 ml blood might be harmful in some of these patients.
    E.5 End points
    E.5.1Primary end point(s)
    • Time from initiation of infusion until final infusion rate, defined as the time from start of infusion until last change in dosing during double blind double dummy treatment.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The 48-hours intervention period.
    E.5.2Secondary end point(s)
    • Time from bolus administration to clinically significant pain relief (change of 2 on 0-10 NRS)
    • Comparision of Tmax, Cmax, and size of AUC0-60 after bolus doses during morphine infusion.
    • Number of bolus doses first 24 and 48 hours.
    • The share of patients not reaching acceptable pain relief within 48 hours (assessed by whether physician and patient concludes that further adjustments in pain medication is required after 48 hours).
    E.5.2.1Timepoint(s) of evaluation of this end point
    All secondary endpoints will be evaluated within the 48-hour intervention or at the end of the intervention period.
    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 Yes
    E.6.6Pharmacokinetic Yes
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Compares two different routes of administration for IMP. Placebo for double dummy blinding.
    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
    Last visit of last subject
    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 months0
    E.8.9.1In the Member State concerned days0
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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
    Patients with incurable disease are in GCP described as a "vulnerable patient population".
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    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)
    Successful analgesic treatment will be continued. If inadequate pain control, the senior consultant responsible for the patient will decide upon one of the following treatment strategies:
    - Further dose titration
    - Conversion to i.v. if patient in s.c. arm
    - co-analgesics
    - Opioid rotation
    - Intrathecal

    After completion of the double blind, double dummy treatment patients enter open label follow-up until discontinuation of parenteral morphine, death or a maximum of four weeks.
    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 Decision2021-12-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-12-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2025-01-31
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