Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   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 on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2008-000529-20
    Sponsor's Protocol Code Number:FENHYDPAI4012
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2008-02-15
    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 ConcernedUK - MHRA
    A.2EudraCT number2008-000529-20
    A.3Full title of the trial
    Comparison of Ionsys® and routine care with morphine IV PCA in the management of early post-operative mobilisation, ability to mobilise and in time to Fitness For Discharge (FFD)
    A.3.2Name or abbreviated title of the trial where available
    Ionsys Mobilisation: Patient Analgesia Control Trial
    A.4.1Sponsor's protocol code numberFENHYDPAI4012
    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 Limited
    B.1.3.4CountryUnited Kingdom
    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 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 Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameIONSYS
    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.3.9.3Other descriptive nameFENTANYL 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
    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 Morphine Sulphate 10mg/ml Injection BP
    D.2.1.1.2Name of the Marketing Authorisation holderWockhardt UK Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameMorphine IV PCA
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNmorphine sulphate
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    Evaluation of the mobilisation characteristics, clinical use, safety and Ease of Care (EOC) of a Fentanyl Iontophoretic Transdermal PCA system (Ionsys) and morphine IV PCA for management of acute moderate to severe post-operative pain in patients who have undergone elective major abdominal (abdominal hysterectomy) or orthopaedic surgery (unilateral primary total hip arthroplasty).
    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 demonstrate the superiority of Ionsys over morphine IV PCA with regard to the patient's ability to mobilise during the management of acute moderate to severe post-operative pain. Ability to mobilise will be assessed through a combined analysis of patient responses to three validated questions:
    1). Because of the system/device I had to be careful when I used my hands or arms (to eat, brush teeth or sit up in bed)
    2). The system/device made it difficult for me to adjust my position in bed
    3). The system/device interfered with my ability to get out of bed and walk around (to chair in room, to bathroom in room/ward, to hallway).
    E.2.2Secondary objectives of the trial
    -To evaluate pain rating (on a scale of 0 to 10) using the Numerical Rating Scale (NRS).
    -To compare the safety of Ionsys in this surgical population with the safety of morphine IV PCA, as assessed by adverse events.
    -To compare the use of Ionsys in this surgical population with morphine IV PCA, as assessed by technical failures of the system/device.
    -To compare the impact on nursing care of each system by means of a validated Ease of Care (EOC) questionnaire.
    -To assess the Patient's Global Assessment (PGA) of the method of pain control at the end of study treatment.
    -To evaluate differences in time taken for the patient to become ‘Fit For Discharge’ (FFD) according to common medical and nursing criteria.
    -To evaluate the impact of pre-operative medication and intra-operative anaesthetic procedures on time taken to achieve fitness for discharge in both treatment groups.
    Please refer to Protocol for further information.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Adult, age 18 or older, male or female.
    2.American Society of Anesthesiology (ASA) pre-operative physical status I or II (see Attachment 1 of the Protocol).
    3.Patients, after an elective major abdominal surgery (abdominal hysterectomy) or orthopaedic surgery (unilateral primary total hip arthroplasty) who are expected to have acute moderate to severe post-operative pain requiring parenteral opioids via PCA for at least 24 hours after surgery.
    4.Expected to remain hospitalised for at least 24 hours post-operatively.
    5.Capable of understanding and co-operating with the requirements of the study and operating the Fentanyl ITS (Ionsys) system or the IV PCA device.
    6.Have signed and dated an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
    7. Have been admitted to the recovery room after:-
    -general anaesthesia
    -spinal anaesthetic of less than or equal to four hours' duration of action or
    -epidural anaesthesia
    during the protocol-specified elective major abdominal or orthopaedic procedure and who are expected to suffer from acute moderate to severe post-operative pain and will require parenteral analgesia for at least 24 hours. 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. When entering the recovery room, patients with epidural or regional anaesthesia must still qualify for needing parenteral analgesia according to the local hospital standards.
    8.Alert and breathing spontaneously for at least 30 minutes in the recovery room; respiratory rate 10 to 24 breaths per minute; SpO2 ≥95% (with or without supplemental oxygen), are able to answer questions and follow commands.
    9.Have a pain score less than or equal to 4 out of 10 on a NRS after titration to comfort with IV morphine. In case of abdominal hysterectomy, this should be measured five minutes after deep breathing and coughing.
    E.4Principal exclusion criteria
    1. Revision of a previous hip arthroplasty in patients who require orthopaedic surgery.
    2. Major abdominal surgery (abdominal hysterectomy) or orthopaedic surgery (unilateral primary total hip arthroplasty) because of malignancy or trauma.
    3. History of allergy or hypersensitivity to:
    -fentanyl
    -and/or morphine
    -and/or an allergy/hypersensitivity to skin adhesives and/or cetylpyridinium chloride
    4. History of psychological opioid dependence and/or known or suspected to be opioid dependent (defined as meeting any of the criteria for substance dependence specified in Attachment 2 of the Protocol)
    5. Known to be opioid tolerant (in the opinion of the investigator) before entering the study. Previous medical and drug history should be considered in this respect.
    6. Known or suspected to have a dependency on any drug substance or alcohol (see Attachment 3 of the Protocol).
    7. Persistent somatoform pain disorder (ICD-10 code F45.4).
    8. Active systemic skin disease or active local skin disease that precludes Ionsys application.
    9. Known to have any of the following:
    -severe chronic obstructive respiratory symptoms;
    -susceptibility to respiratory depression (possible synergistic effect associated with CNS drugs)
    -moderate to severe renal dysfunction
    -a coexisting medical condition, (possibly with chronic pain of another organ) that is likely to interfere with study procedures.
    10. Women who are pregnant, breast feeding, or planning to breast feed within 24 hours of the last dose of study drug. Women of childbearing potential must produce a negative pregnancy test on the day of admission. This does not apply to women scheduled for a hysterectomy.
    11. Require postoperative treatment in the intensive care unit.
    12. 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 pethidine (0.3-0.5 mg/kg IV) or tramadol (1 mg/kg IV) is allowed within 30 minutes of arrival in the recovery room to control post-operative shivering.
    13. Need very high doses of opioids to control their pain (more than 40 mg morphine IV) during titration to comfort or more than 6 hours have elapsed since the patient arrived in the recovery room.
    14. Use of monoamine oxidase inhibitors (MAO) within 14 days is not permitted (severe and unpredictable potentiation by MAOs has been reported with opioid analgesics).
    15.Have previously enrolled in an Ionsys study.
    16. 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.
    17. Will probably require additional surgical procedures within 72 hours.
    18. At the time of final screening assessments are intubated or have a laryngeal mask airway (LMA).
    19.Employees of the investigator or the study centre, with direct involvement in the proposed study or other studies under the direction of the investigator or study centre, as well as family members of the employees of the investigator.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the patient’s evaluation of their ability to mobilise. post-operatively. Assessments will be hourly during the first 6 hours. If the patient is still receiving study treatment, further assessments will be made at hours 8, 12, 24, 48 and 72 hours after application of Ionsys or enablement of the IV PCA. This ability to mobilise will be assessed through a combined analysis of patient responses to the following three validated questions:
    1). Because of the system/device, I had to be careful when I used my hands or arms (to eat, brush teeth or sit up in bed)
    2). The system/device made it difficult for me to adjust my position in bed
    3). The system/device interfered with my ability to get out of bed and and walk around (to chair in room, to bathroom in room/ward, to hallway).
    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 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 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 Yes
    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) Yes
    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 concerned6
    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
    A patient will be considered as having completed the study when he/she attains FFD, and all final assesssments will be performed at that time. Patients who discontinue study treatment due to lack of efficacy are also considered to have completed the study for the purposes of the intent to treat analysis.

    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
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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 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 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)
    Patients will continue to receive the normal standard treatment according to local clinical practice.
    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 Decision2008-03-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-05-20
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2008-11-19
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri Apr 26 23:47:50 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA