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    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2006-002087-26
    Sponsor's Protocol Code Number:FT-019-IM
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-05-16
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2006-002087-26
    A.3Full title of the trial
    An open label, comparative, randomised, balanced crossover trial comparing nasal fentanyl and oral transmucosal fentanyl (Actiq) in breakthrough pain in patients with cancer
    A.3.2Name or abbreviated title of the trial where available
    ND
    A.4.1Sponsor's protocol code numberFT-019-IM
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberND
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNYCOMED (HEADQUARTER)
    B.1.3.4CountryDenmark
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameNasal Fentanyl
    D.3.4Pharmaceutical form Nasal spray, solution
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPNasal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFentanyl
    D.3.9.1CAS number 990-73-8
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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.IMP: 2
    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 ACTIQ
    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 nameFENTANIL CITRATO
    D.3.4Pharmaceutical form Compressed lozenge
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPBuccal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFentanyl Citrate
    D.3.9.1CAS number 990-73-8
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    breakthrough pain in patients with cancer
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Level PT
    E.1.2Classification code 10058019
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the efficacy of nasal fentanyl (NF) to oral transmucosal fentanyl (Actiq) (hereafter Actiq) in the management of break through pain in cancer patients.
    E.2.2Secondary objectives of the trial
    To compare patientsﾒ general impression and preference of NF and Actiq To explore the relationship between NF doses and doses of current opioid for breakthrough pain (BTP) and the relationship between dose of NF and of background opioid To assess safety and tolerability of NF
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    All inclusion criteria must be answered ''yes'' 1.Has the patient given informed consent according to applicable requirements before any trial-related activities? 2.Is the patient a cancer patient with breakthrough pain (BTP)? 3.Is the patient 18 years or above? 4.Has the patient received for at least the past month either oral morphine, oxycodone, hydromorphone or transdermal fentanyl for treatment of background pain? 5.Is the current dose of the scheduled background pain opioid of the patient equivalent to 60-500 mg oral morphine/day or to transdermal fentanyl 25-200ﾵg/hour 6.Is the background pain gererally stable and on average controlled to a mild level (defined as <=4 on an 11 point NRS)by the background pain opioid? 7.Is the BTP episodes in general of so severe pain intensity that the patient judges he/she needs additional analgesics( apart from background pain medication)? 8.In general does the patient have at least three BTP episodes per week but no more than four BTP episodes per day while using a stable fixed-schedule opioid regimen? 9.Has the patient obtained at least partial relief of BTP with his/her usual immediate release strong opioid i.e. morphine, oxycodone, hydromorphine or transmucosal fentanyl? 10.Is the life expectancy of the patient at least 3 months? 11.Is the patient able to use nasal drugs? For female patients of child bearing potential: 12.Does the patient use adequate contraceptive precaution in the trial period? 13.Does the patient have a negative urine or blood pregnancy test? 14.was the backgroung pain during minimum five of the seven days controlled to a mild level (defined as <=4 on an 11 point NRS)by the background pain opioid? 15.did the patient have at least three BTP episodes during the seven days but no more than four BTP episodes per day? 16.was the BTP(s) of such severe pain intensity that the patient took additional analgesics (apart from the usual pain opioid)?
    E.4Principal exclusion criteria
    All exclusion criteria must be answered ''no'' 1.Does the patient have a recent history of substance abuse? 2.Is the patient pregnant or nursing during the trial period? 3.Has the patient neurological or psychiatric impairment that may compromise data collection? Has the patient severe hepatic impairment Has the patient had any recent therapy which could potentially alter pain response to analgesics to a degree where the need for background pain opioid will be less than 60 mg morphine or morphine equivalents/day or less than 25ﾵg/hour transdermal fentanyl or the number of BTP episodes will be less than three per week during the trial period Has the patient ever had oral/nasal surgery or facial radiotherapy ? (Tooth extraction performed more than 30 days prior to screening is allowed) Has the patient received radiotherapy within the last 30 days or is the patient scheduled to receive radiotherapy within the next 8 weeks Has the patient been treated with MAO inhibitor within the last 14 days Has the patient been treated with Methadone within the last 32 days Has the patient been treated with Buprenorphine within the last 16 days Does the patient have an impaired respiratory function to an extent which may severely increase the risk of clinically relevant respiratory depression by BTP fentanyl treatment Does the patient use drugs for nasal administration Does the patient have nasopharyngeal probe Is the patient known to be hypersensitive to fentanyl or to other opioids or any of their excipients Has the patient any head injury, primary brain tumour or other pathological conditions which could significantly increase the risk of increased intracranial pressure or impaired consciousness Has the patient concomitant participation in any other trial with an investigational drug or device apart from cancer treatment within 30 days prior to inclusion in this trial Does the patient have pathological conditions of the nasal and/or oral cavity as contraindication to nasal fentanyl or Actiq Was the patient included in FT-016-IM, FT-017-IM or FT-018-IM
    E.5 End points
    E.5.1Primary end point(s)
    time of onset of meaningful pain relief recorded by stopwatch.
    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 Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Information not present in EudraCT
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    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
    due diverse formulazioni, nasale vs orale
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    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.1.3Elderly (>=65 years) Yes
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2007-05-16. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 115
    F.4.2.2In the whole clinical trial 115
    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 Decision2007-01-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-02-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-09-05
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