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    Summary
    EudraCT Number:2015-002533-22
    Sponsor's Protocol Code Number:EB-1
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-06-12
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2015-002533-22
    A.3Full title of the trial
    Palliation of dyspnea with morphine in patients with interstitial lung disease
    Palliation af dyspnø med morfin hos patienter med fibroserende interstitiel pneumonitis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Morphine for dysnea in patients with lung fibrosis
    Morfin som behandling af åndenød hos patienter med lungefibrose
    A.3.2Name or abbreviated title of the trial where available
    MORPHILD
    MORFILD
    A.4.1Sponsor's protocol code numberEB-1
    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 SponsorAarhus University Hospital
    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 supportAarhus University Hospital
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAarhus University Hospital
    B.5.2Functional name of contact pointDept of respiratory diseases
    B.5.3 Address:
    B.5.3.1Street AddressNørrebrogade 44
    B.5.3.2Town/ cityAarhus C
    B.5.3.3Post code8000
    B.5.3.4CountryDenmark
    B.5.6E-mailkarbends@rm.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 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 nameMorphine hydrochloride
    D.3.4Pharmaceutical form Oral drops
    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 INNRøde dråber
    D.3.9.1CAS number 52-26-6
    D.3.9.2Current sponsor codeRøde dråber
    D.3.9.3Other descriptive nameMORPHINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB14596MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 Yes
    D.3.11.13.1Other medicinal product typeThe oral drops are produced at the pharmacy. 100 g drops: Morphine hydrochlorid 2 g Ethanol 96 % 11,3 g Red color diluendum DAK 0,1 g Cleansed water 86,6 g
    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 placeboOral drops
    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
    Interstitial Lung disease
    Interstitielle lungesygdomme
    E.1.1.1Medical condition in easily understood language
    Lung fibrosis
    Lungefibrose
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    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
    To investigate if morphine hydrochloride administered for 7 days is safe and attenuates dyspnea in patients with interstitial lung disease and dyspnea
    Formålet med studiet er at undersøge sikkerhed og effekt på dyspnø af morfin i form af røde dråber hos patienter med fibroserende lungesygdom.
    E.2.2Secondary objectives of the trial
    To investigate if the abovementioned treatment reduces anxiety and improvesexercise capacity
    At undersøge, om morfinbehandlingen mindsker angst og forbedrer den fysiske kapacitet målt ved 6 minutters gangtest
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • A diagnosis of interstitial lung disease (IPF, NSIP, RA-ILS, Scl-ILS, MCTD-ILS, asbestosis, drug induced ILD, un classified ILD)
    • Dyspnea Medial Research Councils (MRC) dyspnea score ≥ 3
    • Informed written consent
    • Age ≥ 18 years
    • Habile
    • For fertile women: negative HCG before inclusion
    • For fertile and sexualle active persons: Secure birth control during the study period and the day after
    • Fibroserende interstitiel lungesygdom (IPF, NSIP, RA-ILS, Scl-ILS, MCTD-ILS, asbestose, drug induceret ILS, uklassificerbar ILS)
    • Dyspnø svt. Medial Research Councils (MRC) dyspnøscore ≥ 3
    • Informeret skriftligt samtykke
    • Alder ≥ 18
    • Habil, myndig
    • For fertile kvinder defineret ved amenorré i mindre end 12 måneder: negativ HCG inden indtræden i forsøget
    • For fertile og seksuelt aktive forsøgspersoner: anvendelse af sikker antikonception under morfinindtaget samt dagen efter: Spiral eller hormonel antikonception (p-piller, implantat, transdermal depotplastre, vaginalring eller depotinjektion).
    E.4Principal exclusion criteria
    • Treatment with morpine or morphne analogues
    • Allergy towards morphine
    • Behandling med fast morfin eller morfinanaloger
    • Allergi eller intolerance overfor morfin eller morfinanaloger
    E.5 End points
    E.5.1Primary end point(s)
    Change in VAS dyspnea score after 7 days treatment with oral morhine drops
    Primære endepunkt:
    Forskellen i VAS score for dyspnø før og efter 1 uges behandling med røde dråber.

    E.5.1.1Timepoint(s) of evaluation of this end point
    at baseline and after 7 days
    Ved baseline og efter 7 døgn
    E.5.2Secondary end point(s)
    Frequency of breathing
    Blood pressure and pulse
    Arterial oxygen and CO2 content
    6 min walk test distance, peripheral saturation and Borgs dyspnea score at the 6 min walk test
    Cough (VAS and Leicester cough score)
    ILD specific life quality (KBILD)
    depression and anxiety score (GAD-7).
    Respirationsfrekvens, blodtryk og puls, blodets indhold af ilt og kultveilte, distance, graden af desaturation og Borgs dyspnø skala ved en 6 minutters gangtest, dyspnø (VAS), hoste (VAS og Leicester hoste score) samt lungefibrosespecifik livskvalitet (KBILD) og depression og anxiety score (GAD-7).
    E.5.2.1Timepoint(s) of evaluation of this end point
    At baseline and after 7 days
    Ved baseline og efter 7 døgn
    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 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
    last visit of the last subject undergoing the trial
    Sidste besøg for sidste deltager
    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 months3
    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.1.2.1Number of subjects for this age range: 18
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 18
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state36
    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)
    All patients are controlled at the deparatment of respiratory diseases and are seen on a regular basis. The patients will continue their visits after the trial
    Alle deltagere kontrolleres jævnligt på Lungemedicinsk Afdeling, Aarhus Universitetshospital, og de vil fortsætte deres forløb efter forsøget.
    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 Decision2015-08-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-08-31
    P. End of Trial
    P.End of Trial StatusCompleted
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