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    Summary
    EudraCT Number:2012-002469-37
    Sponsor's Protocol Code Number:CRO-2012-17
    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:2012-09-12
    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 number2012-002469-37
    A.3Full title of the trial
    Phase II clinical study on the efficacy and safety of procedural analgesia of oral transmucosal fentanyl citrate in oncologic patients eligible to permanent central venous catheter
    Studio clinico di fase II su efficacia e sicurezza della analgesia procedurale con fentanile transmucosale nei pazienti oncologici candidati al posizionamento di impianto venoso centrale a permanenza
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of efficacy and safety of analgesia with transmucosal fentanyl citrate in oncologic patients eligible to permanent central venous catheter
    Valutazione dell'efficacia e sicurezza dell'analgesia con fentanile transmucosale durante posizionamento di accesso venoso centrale permanente nei pazienti oncologici
    A.4.1Sponsor's protocol code numberCRO-2012-17
    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 SponsorCENTRO DI RIFERIMENTO ONCOLOGICO DI AVIANO
    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 supportCentro di Riferimento Oncologico (CRO) - IRCCS
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCentro di Riferimento Oncologico (CRO) - IRCCS
    B.5.2Functional name of contact pointDirezione Scientifica
    B.5.3 Address:
    B.5.3.1Street AddressVia Gallini 2
    B.5.3.2Town/ cityAviano
    B.5.3.3Post code33081
    B.5.3.4CountryItaly
    B.5.4Telephone number0434 659282
    B.5.5Fax number0434 659527
    B.5.6E-maildirscienti@cro.it
    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 EFFENTORA*4CPR MUCOSAOS 100MCG
    D.2.1.1.2Name of the Marketing Authorisation holderCEPHALON Srl
    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.3.4Pharmaceutical form Oromucosal capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOromucosal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFENTANYL CITRATE
    D.3.9.4EV Substance CodeSUB02129MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 typeanalgesico oppioide
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Cancer patients eligible to permanent central venous catheter due to chemotherapeutic treatment
    Pazienti oncologici candidati al posizionamento di catetere venoso centrale a permanenza (PORT) per esecuzione di trattamento chemioterapico
    E.1.1.1Medical condition in easily understood language
    Cancer patients eligible to permanent central venous catheter due to chemotherapeutic treatment
    Pazienti oncologici candidati al posizionamento di catetere venoso centrale a permanenza (PORT) per esecuzione di trattamento chemioterapico
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level PT
    E.1.2Classification code 10053377
    E.1.2Term Central venous catheterisation
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    evaluation of efficacy of fentanyl transmucosal citrate of improving analgesia during Central Venous Catheterization
    obbiettivo primario è valutare la efficacia del OTFC nel migliorare la analgesia e ridurre lo stress dei pazienti candidati al posizionamento di un accesso vascolare venoso a permanenza
    E.2.2Secondary objectives of the trial
    evaluation of safety of fentanyl transmucosal citrate of improving analgesia during Central Venous Catheterization
    obbiettivi secondari sono valutare la sicurezza del OTFC in pazienti naive per gli oppioidi candidati ad una analgesia procedurale in ambiente controllato e la influenza di ansia e paura del dolore nella percezione di questo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) patients > 18 years
    2) Histologically confirmed diagnosis of cancer
    3) Eligibility to permanent central venous catheter
    4) Absence of cognitive impairment
    5) ability to give informed consentg
    1) Pazienti oncologici con età maggiore di 18 anni
    2) Diagnosi di cancro confermata istologicamente
    3) Indicazione al posizionamento di catetere venoso centrale permanente collegato a port sottocutaneo in regime di ricovero ospedaliero

    4) Capacità cognitive integre

    5) Pazienti che danno il loro consenso informato alle procedure oggetto dello studio
    E.4Principal exclusion criteria
    1)patients alreday treated with oppioids due to chronic oncologic pain
    2)patients with previous nausea or vomiting due to oppioid treatment
    3)patients with previous intolerance to fentanyl e.v. or transmucosal
    4)chronic respiratory failure
    5)renal or hepatic impairment
    1) Pazienti già in trattamento con oppioidi per dolore cronico oncologico
    2) Pazienti con documentata storia di nausea importante e vomito correlati alla somministrazione di oppioidi
    3) Pazienti con anamnesi positiva per intolleranza al fentanile i.v. o OFTC
    4) Pazienti con insufficienza respiratoria cronica di grado grave o moderato
    5) Pazienti con alterazione della funzionalità renale od epatica
    E.5 End points
    E.5.1Primary end point(s)
    Analgesic efficacy of transmucosal fentanyl citrate
    Efficacia analgesica del fentanil citrato transmucosale
    E.5.1.1Timepoint(s) of evaluation of this end point
    10 minutes after the end of central venous chateterization
    10 minuti dopo la fine della procedura di incannulazione venosa centrale
    E.5.2Secondary end point(s)
    Safety of transmucosal fentanyl citrate
    Sicurezza del fentanil citrato transmucosale
    E.5.2.1Timepoint(s) of evaluation of this end point
    10 minutes after the end of central venous chateterization and 4 hours after drug administration
    10 minuti dopo la fine della procedura di incannulazione venosa centrale e a 4 ore dalla somministrazione del farmaco
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial1
    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.8.4.1Number of sites anticipated in Member State concerned1
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months12
    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.1.1Number of subjects for this age range: 0
    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: 45
    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 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 state65
    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)
    Monitoring of respiratory rate, arterial blood pressure and peripherical arterial oxygenation at during and after 4 hours of drug administration
    Monitoraggio dei parametri vitali e degli effetti collaterali del trattamento fino a 4 ore dalla somministrazione del farmaco
    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 Decision2012-09-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-09-03
    P. End of Trial
    P.End of Trial StatusOngoing
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