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    Summary
    EudraCT Number:2013-003319-23
    Sponsor's Protocol Code Number:SLF_SCMO_0113
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2013-10-23
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2013-003319-23
    A.3Full title of the trial
    SUBLINGUAL FENTANYL VERSUS SUBCUTANEOUS MORPHINE
    FOR THE MANAGEMENT OF SEVERE CANCER PAIN EPISODES IN PATIENTS ON OPIOID TREATMENT:
    A DOUBLE-BLIND RANDOMIZED NON–INFERIORITY TRIAL.

    fentanyl sublinguale versus morfina sottocute per la gestione del dolore episodico intenso oncologico in pazienti in trattamento con oppioidi: studio clinico randomizzato di non inferiorità in doppio cieco
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    comparison between sublingual fentanyl and subcutaneous morphine in patients with sever episode of cancer pain
    A.4.1Sponsor's protocol code numberSLF_SCMO_0113
    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 SponsorFondazione IRCCS Istituto Nazionale dei Tumori
    B.1.3.4CountryItaly
    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 supportFondazione IRCCS Istituto Nazionale dei Tumori
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFondazione IRCCS Istituto Nazionale dei Tumori
    B.5.2Functional name of contact pointCaraceni
    B.5.3 Address:
    B.5.3.1Street Addressvia Venezian,1
    B.5.3.2Town/ cityMilan
    B.5.3.3Post code20133
    B.5.3.4CountryItaly
    B.5.4Telephone number+390223902792
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 Abstral
    D.2.1.1.2Name of the Marketing Authorisation holderProstrakan
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 namesublingual fentanyl
    D.3.2Product code N02AB03
    D.3.4Pharmaceutical form Sublingual tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSublingual 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 placeboSublingual tablet
    D.8.4Route of administration of the placeboSublingual use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    pain due to cancer
    dolore da cancro
    E.1.1.1Medical condition in easily understood language
    cancer pain
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    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 main aim of the study is to show non inferiority of sublingual fentanyl (SLF) with respect to subcutaneous morphine (SCMO) in the treatment of severe cancer pain episodes in the first 30 minutes after drug assumption, in cancer patients regularly treated with opioids.
    Pain intensity in the first 30 minutes after drug administration, calculated as average value of pain “right now” scores at 10, 20 and 30 minutes after drug administration is the main outcome measure.
    E.2.2Secondary objectives of the trial
    Secondary efficacy endpoints are to compare:
    a) analgesic efficacy at 60 minutes
    b) proportion of patients needing a second dose of opioid
    c) proportion of patients that express a preference for one administration route
    d) safety and tolerability (adverse drug reactions (ADR), adverse events (AEs) and serious adverse events (SAE) occurring during the study).
    e) effectiveness, safety and tolerability of SLF and SCMO in patients regularly on low dosages of opioids.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - active oncological disease causing pain
    - stable opioid therapy (> 3 days)
    - adequate pain control in the previous 24 hours (average pain in the previous 24 hours of ≤ 4/10)
    - episode of breakthrough pain occurring at the time of the visit (current pain ≥ 6/10)
    - previous 24 hours daily dosage of opioid, calculated as equianalgesic dose of oral morphine, between 20 and 120 mg/day
    - written informed consent to study participation
    - age ≥ 18 years
    E.4Principal exclusion criteria
    cognitive deficits compromising the ability to assess pain or pain relief
    - previous therapy with sublingual fentanyl
    -pregnancy or breastfeeding
    - severe hepatic and/or renal impairment
    - participation in other clinical trial that might interfere with the study results

    E.5 End points
    E.5.1Primary end point(s)
    to show non inferiority of sublingual fentanyl (SLF) with respect to subcutaneous morphine (SCMO) in the treatment of severe cancer pain episodes in the first 30 minutes after drug assumption, in cancer patients regularly treated with opioids.
    E.5.1.1Timepoint(s) of evaluation of this end point
    at 0, 10, 20, 30, 60 minutes after the beginning of the study
    E.5.2Secondary end point(s)
    effectiveness, safety and tolerability of SLF and SCMO
    E.5.2.1Timepoint(s) of evaluation of this end point
    after 30 and 60 minutes after the beginning of the study
    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 No
    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) 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) Yes
    E.8.2.2Placebo No
    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
    after 15 months from the first patients enclosed
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    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: 42
    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 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 state112
    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
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Fondazione IRCCS Istituto Nazionale dei Tumori
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-11-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-09-17
    P. End of Trial
    P.End of Trial StatusOngoing
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