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    Summary
    EudraCT Number:2005-004087-24
    Sponsor's Protocol Code Number:FEN-PAI-3002
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-12-10
    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 ConcernedGermany - BfArM
    A.2EudraCT number2005-004087-24
    A.3Full title of the trial
    Global assessment of treatment with IONSYS and its handling by patients, doctors and nursing staff in the management of acute moderate to severe post-surgery pain in hospitalised patients.
    A.4.1Sponsor's protocol code numberFEN-PAI-3002
    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 GmbH
    B.1.3.4CountryGermany
    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 40 Mikrogramm pro Dosis iontophoretisches transdermales System
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse
    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 IMPTransdermal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFentanyl hydrochloride
    D.3.9.1CAS number 437-38-7
    D.3.9.3Other descriptive nameN-phenyl-N-(1-2-phenylethyl-4-piperidyl)propanamide hydrochloride
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 Yes
    D.3.11.13.1Other medicinal product typeIontophoretic Transdermal System (patient controlled)
    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
    Acute, moderate to severe postoperative pain after elective surgery in a hospital setting in patients needing at least 24 hours strong opioids for pain therapy.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10054711
    E.1.2Term Postoperative pain
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Subject's overall assessment of pain treatment method of the last 24 hours.
    E.2.2Secondary objectives of the trial
    - Subject´s, physician´s and staff´s global assessment at additional time-points
    - Current pain intensity rating
    - Number of hours per day with maintained "comfort level" (NRS*≤ 4)
    - Evaluation of the post-operative progress of the patient every 24 hrs in regard of:
    . time out of bed
    . time to mobilisation
    - Well beeing during the post-operative phase (PPP33®-questionaire)
    - Physiotherapy ability
    - Safety and tolerability of IONSYS as a hospital’s treatment option
    - Comprehensibility of the information material
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age 18 years or more; male or female
    2. American Society of Anesthesiology (ASA) pre-operative physical status I, II or III
    3. Expected hospitalization of at least 24 hours
    4. Expected moderate to severe pain requiring treatment with parenteral opioids of
    at least 24 hrs. following major elective surgery
    5. Subject's capability to operate the iontophoretic transdermal system, under-
    standing of the requirements of the clinical study and willingness to cooperate
    6. Written Informed Consent, signed and dated during the pre-operative phase
    7. Compliance with the following criteria in the recovery room after an elective
    major surgery requiring a parenteral opioid treatment for at least 24 hours:
    · General anesthesia
    . Spinal anesthesia of ≤ 4 h action time or
    . Epidural anesthesia
    . Epidural anesthesia
    Epidural or local anesthesia: only when the administered analgesic was short-
    lasting and given only for the period of surgery and not for the period in the
    recovery room.
    8. Alertness for at least 30 min. and spontaneous breathing in the recovery room
    Respiratory rate: 10-24 breaths/minute; SpO2 90% or more [with or without
    supplemental oxygen. Oxygen mask; max. CPAP)]; ability to answer questions
    and follow commands
    9. Pain score of ≤ 4 out of 10 on a numerical rating scale (NRS) of titration to com-
    fort. In the case of abdominal surgery, pain should be measured 5 minutes after
    deep breathing and coughing.
    E.4Principal exclusion criteria
    1. Anamnestic allergy or hypersensitivity to:
    ·fentanyl
    ·and/or cetylpyridinium HCl
    ·and/or skin adhesives
    2. Suspected or known dependence on strong opioids or a very high need for
    strong opioids already existing prior to the start of the study
    3. Psychological dependence on strong opioids before the start of the clinical study
    4. Suspected or known abuse of any drug substance or alcohol
    5. Chronic pain disorder
    6. Active systemic or active topical skin disease that precludes application of the
    iontophoretic transdermal system
    7. Conditions associated with an increased risk of respiratory depression such as:
    ­ - Chronic obstructive pulmonary diseases or conditions causing a predisposition
    for hypoventilation
    - ­Head injuries, increased intracranial pressure, brain tumour, impaired
    consciousness, or coma
    8. Post-operative application of CNS active drugs that may increase the risk of re-
    spiratory depression as a result of additive effects, but excluding:
    ­ - Anti-depressants/anxiolytics provided they are used for the same therapeutic
    indication as in the time preceding the operation.
    ­ - Concomitant medication specified in section 3.3.5.
    9. Severe hepatic or renal dysfunction
    10. Women who are pregnant, breast feeding, or planning to breast feed within 24
    hrs. of the last dose of study drug. Women of childbearing potential must pro-
    duce a negative pregnancy test prior to admission. This does not apply to
    women scheduled for a hysterectomy.
    11. Participation in a previous clinical trial evaluating the transdermal PCA system, in
    other clinical studies conducted in parallel and participation in a clinical study
    within 30 days prior to enrolment in this clinical study
    12. Post-operative pain during the first 24 hours that can usually be managed with
    oral or non-opioid analgesia
    13. Employees of the investigator or the institution who had direct involvement in
    the study or other trials under the direction of the investigator/institution
    14. Intra-operative administration of opioids other than morphine, fentanyl,
    sulfetanil, alfentanil or remifentanil and piritramid as well as up to 50 mg
    pethidine IV for shivering (only within 30 minutes after arrival in the recovery
    room)
    15. Very high need of opioids for pain control in the postoperative titration phase
    (> 40 mg morphine iv or > 60 mg piritramide IV or equivalent dose of another
    strong opioid)
    16. Elapse of more than 6 hours since arrival in the recovery room before
    reaching the pain level ≤ 4
    17. Probable Requirement of additional surgical procedures within 72 hours
    18. Intubation and use of a laryngeal mask airway at the time of final screening
    assessments
    E.5 End points
    E.5.1Primary end point(s)
    Subject's global assessment at 24 hours
    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 Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    subjects' satisfaction
    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 No
    E.8.1.2Open No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned25
    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 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 months9
    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.1.3Elderly (>=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 Yes
    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 2007-12-10. Yes
    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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state200
    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)
    At the end of the study, either because the patient has completed the study on a regular basis or any of the discontinuation criteria has occured, the patient will receive pain therapy according to the common hospital guidelines.
    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 Decision2007-12-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-01-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-09-26
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