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    Summary
    EudraCT Number:2008-002074-35
    Sponsor's Protocol Code Number:FENHYDPAI4014
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2008-05-22
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2008-002074-35
    A.3Full title of the trial
    Clinical outcome study in postoperative pain management to demonstrate the efficacy and safety of IONSYS (fentanyl ITS Iontophoretic Transdermal System) in daily clinical practice and to assess its convenience (IPAC)
    A.3.2Name or abbreviated title of the trial where available
    IPAC
    A.4.1Sponsor's protocol code numberFENHYDPAI4014
    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 SponsorJanssen-Cilag N.V./S.A.
    B.1.3.4CountryBelgium
    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 Yes
    D.2.1.1.1Trade name IONSYS
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 Iontophoretic transdermal system
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIontophoresis 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) 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 No
    D.3.11.8Extractive medicinal product No
    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 Information not present in EudraCT
    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
    moderate to severe acute pain in postoperative patients who have undergone elective spine or orthopaedic surgery
    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 primary objective of this study is to assess the need for IV access during postoperative pain treatment with strong opioids using fentanyl ITS.
    E.2.2Secondary objectives of the trial
    Additional endpoints:
    · The administration of medication for opioid related side effects or administration of additional analgesic treatment (intravenous/oral) during the use of fentanyl ITS will be evaluated
    · Patient satisfaction at end: Patient Global Assessment
    · Pain Scores (NRS): at 6, 12 and 18 hours after application of ITS, and at every change of ITS
    · Nurse satisfaction at end: Nurse Global Assessment
    · Physician satisfaction at end: Physician Global Assessment
    · Device related application site reaction will be recorded (including those of prolonged nature)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients must satisfy the following criteria to be enrolled in the study:
    1. Adult, aged 18 or older, male or female.
    2. American Society of Anaesthesiology (ASA) pre-operative physical status I, II, or III (Attachment 1).
    3. If the patient is female and of childbearing potential, she must have a negative pregnancy test at hospital admission.
    4. Patients who will undergo elective spine or orthopaedic surgery.
    5. Patients who are expected to have moderate or severe pain requiring parenteral opioids for at least 48 hours after surgery.
    6. Patients who are capable of understanding and cooperating with the requirements of the study and operating fentanyl ITS.
    7. Patients who have signed and dated the informed consent to participate in the study during the preoperative assessment.
    8. Patients who have been admitted to the PACU after general anaesthesia, spinal anaesthetic of < 4 hours duration of action or epidural anaesthesia. Patients with epidural or regional anaesthesia will only be included if the provided analgesia was short lasting and was only given for the period of surgery and not for the period in the recovery room.
    9. Patients who are alert and breathing spontaneously for at least 30 minutes in the PACU; respiratory rate 10 to 24 breaths per minute; patients must be able to answer questions and follow commands.
    10. Patients with a pain score less than or equal to 4 out of 10 on a Numerical Rating Scale (NRS) at movement of the operated limb or body region, after titration to comfort according to current postoperative procedures.
    11. Patients who are expected to remain hospitalised for at least 48 hours postoperatively.
    E.4Principal exclusion criteria
    Potential patients who meet any of the following criteria will be excluded from participating in the study:
    1. Patients with a history of allergy or hypersensitivity to fentanyl and/or an allergy/hypersensitivity to skin adhesives and/or cetylpyridinium chloride.
    2. Patients who are known or suspected to be strong opioid dependent, or who have a too high need for strong opioids.
    3. Patients with a history of opioid dependence before the start of the study, defined as meeting any of the criteria for substance dependence specified in Attachment 2.
    4. Patients who are known or suspected to have abused any drug substance or alcohol.
    5. Patients with chronic pain disorder (DSM-IV 307.80/89 –
    ICD 10: F45.4).
    6. Patients with active systemic skin disease or active local skin disease that precludes fentanyl ITS application.
    7.Patients known to have any of the following:
    · severe chronic obstructive respiratory symptoms;
    · susceptibility to present respiratory depression (possible synergistic effect associated with CNS drugs);
    · patients who have a coexisting medical condition, (possibly with chronic pain of another organ) that is likely to interfere with study procedures.
    Remark: - use of muscle relaxants is allowed (during the course of the general anaesthesia);
    - use of anti-depressants/anxiolytics is allowed provided that they were taken for the same indication before surgery;
    - the use of monoamineoxidase-inhibitors (MAO inhibitors) is not allowed during (or 14 days prior to) treatment with fentanyl ITS.
    8. Women who are pregnant, breast feeding, or planning to breast feed within 7 days of last dose of study drug.
    9. Patients who have taken any investigational drug or used an experimental medical device within 30 days before the start of the study or are currently enrolled in another investigational drug study.
    10. Patients who received regular treatment with transdermal strong opioids within 14 days prior to surgery.
    11. Patients who have received peri-operative administration of opioids other than morphine, fentanyl, sufentanil, alfentanil or remifentanil.
    Exception: If there are no medical contraindications, one dose of meperidine, up to 50 mg IV, is allowed within 30 minutes of arrival in the PACU for treatment of shivering.
    12. Patients who need postoperatively very high doses of opioids for pain control (more than 40 mg morphine/h equivalent or more than 60 mg pritramid to reach comfort zone (NRS £ 4)) or when more than 6 hours have elapsed since the patient arrived in the PACU.
    13. Patients whose postoperative pain is managed with IV PCA or EPI PCA or CEI (continuous epidural infusion).
    14. Patients whose postoperative pain would normally be managed with oral or non-opioid analgesia during the first 48 hours.
    15. Patients who are being treated in the intensive care unit.
    16. Patients who will probably require additional surgical procedures within 72 hours.
    17. Patients who are intubated or have a laryngeal mask airway (LMA) at the time of final screening assessments (T0).
    18. Patients who are employees of the investigator or the institution who have direct involvement in the study or other trials under the direction of the investigator.
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint: the use of IV line during treatment with fentanyl ITS will be evaluated. Therefore we will document (at each time point) the amount of patients who have an IV line and compare the actual usage of the IV line with the intended use of the IV line.
    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 No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    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.8.3 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.8.4.1Number of sites anticipated in Member State concerned15
    E.8.5The trial involves multiple Member States Information not present in EudraCT
    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 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
    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 months7
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 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 state150
    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 Decision2008-06-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-07-04
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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