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The European Union Clinical Trials Register allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   41191   clinical trials with a EudraCT protocol, of which   6743   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).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
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    Summary
    EudraCT Number:2008-002653-21
    Sponsor's Protocol Code Number:C-2005-036-01
    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:2008-06-24
    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 number2008-002653-21
    A.3Full title of the trial
    Number of Doses and Time to Onset Of Pain Relief (Analgesic Effect) Using the IONSYS™ System [Fentanyl Iontophoretic Transdermal System (40 µg)]
    A.4.1Sponsor's protocol code numberC-2005-036-01
    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 International NV, Turnhoutseweg 30, 2340 Beerse, Belgium
    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 40 micrograms per dose iontophoretic transdermal system
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International N.V
    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 HCL
    D.3.9.1CAS number 1443-54-5
    D.3.9.3Other descriptive namePropanamide, N-phenyl-N-[1-(2-phenlethyl)-4piperidinyl]-monohydrochloride
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10.8
    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 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
    Patients who experience moderate to severe pain and required opioid analgesia for 24 hours immediately following non laparoscopic total abdominal hysterectomy surgery
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10033371
    E.1.2Term Pain
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the precise dosing pattern of IONSYS system use in post operative patients
    E.2.2Secondary objectives of the trial
    To assess the feasibility of using the double stopwatch methodology for assessing time to onset of pain relief using the IONSYS system in post operative patients
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients who have signed an informed consent form, prior to any study procedures being done, indicating that they understand the purpose of and procedures required, for the study and are willing to participate in the study.

    2. Patients who are adult females, 18 years of age or older.

    3. Patients who have been admitted to Post Anesthesia Care Unit (PACU) after a general anesthesia with a surgical time of up to 4 hours for non-laparoscopic total abdominal hysterectomy.

    4. Patients who are awake and breathing spontaneously; respiratory rate 8 to 24 breaths per minute, SpO2 > 90% (with or without supplemental oxygen).

    5. Patients who have been in the PACU for at least 30 minutes, are alert, able to answer questions and follow commands, state they are comfortable (titrated with IV fentanyl as clinically appropriate) and report their pain is less than or equal to 4 on a scale of 0 (no pain) to 10 (worst possible pain).

    6. Patients who are expected to remain hospitalized for at least 24 hours post-operatively.

    7. Patients, who in the opinion of the investigator, are expected to have moderate or severe pain requiring parenteral opioids for at least 24 hours after surgery.

    8. Patients who are capable of understanding and cooperating with the requirements of the study and operating the IONSYS™ system.

    9. Patients who have an American Society of Anesthesiology (ASA) physical status of I, II or III (Appendix 4).

    10. Patients who can understand and communicate in the local language.
    E.4Principal exclusion criteria
    1. Patients with a history of allergy, hypersensitivity, or intolerance to fentanyl, skin adhesives, and/or cetylpyridinium chloride.

    2. Patients who received long acting intra-operative spinal anesthesia or epidural anesthesia for the surgery or who are expected to have post-operative analgesia supplied by a continuous regional technique or patient controlled epidural analgesia.

    3. Patients who received local anesthesia in the surgical area.

    4. Patients with a history of opioid dependence before the start of the study, defined as meeting any of the DSM-IV-TRÔ Criteria for Substance Dependence specified in Appendix 5.

    5. Patients who have used any illicit drugs of abuse or abused alcohol within 30 days before the start of the study.

    6. Patients with active systemic skin disease or active local skin disease that precludes IONSYSÔ system application.

    7. Patients who are breastfeeding.

    8. Patients who have a coexisting medical condition that is likely to interfere with study procedures.

    9. Patients with a malignancy or with a history of malignancy within the past 5 years, except for a superficial squamous or basal cell carcinoma that has been treated with local excision and is no longer present.

    10. Patients with a significant history (within the past 2 year) of bradyarrhythmias, acute or chronic pulmonary disease, sleep apnea [e.g., are on home continuous positive airway pressure, CPAP], impaired hepatic function, impaired renal function that may impair their reliable participation in the study or necessitate the use of medication not permitted in this study.

    11. Patients with a history (within the past 6 months) of a major psychiatric disorder.

    12. Patients with a history of suicidal ideation or suicidal attempts within the past two years.

    13. Patients with severe hearing impairment.

    14. Patients who in the opinion of the investigator should not be enrolled in the study because of precautions, warnings, or contraindications outlined in the E-TRANSâ fentanyl investigator’s brochure and/or fentanyl package insert.

    15. Patients who are expected to require intensive care postoperatively.

    16. Patients who will probably require additional surgical procedures within 24 hours.

    17. Patients who receive intra- and/or post-operative administration of opioids other than morphine, hydromorphone, fentanyl, sufentanil or alfentanil or received long acting opioids. Exception: If there are no medical contraindications, meperidine up to 50mg IV is allowed while in PACU for shivering.

    18. Patients who are intubated or have a laryngeal mask airway (LMA) at the time of final baseline assessments (at the time of IONSYSÔ application).

    19. Patients who are known or suspected to be opioid tolerant. For the purposes of this study, a patient will be considered to have a potential tolerance to opioids if for 4 consecutive days prior to surgery, they have been taking short acting/short acting combination opioid analgesic greater than codeine 120 mg daily, hydrocodone 40 mg daily, tramadol 200 mg daily, or oxycodone 40 mg daily or if they are on any dose of strong opioid analgesic such as morphine, hydromorphone or fentanyl.

    20. Patients with increased intracranial pressure.

    21. Patients who have taken any investigational drug or used an investigational device within 30 days before the start of the study or are currently enrolled in another investigational drug or device study.

    22. Patients who are unwilling or unable to abide by the requirements of the study.

    E.5 End points
    E.5.1Primary end point(s)
    As defined in protocol
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    The adhesion of each IONSYS system
    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 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 concerned2
    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
    n/a
    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 months7
    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 months7
    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 No
    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 Yes
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    patients who are breastfeeding will be excluded
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 100
    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 Decision2008-06-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-09-01
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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