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 are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   36821   clinical trials with a EudraCT protocol, of which   6079   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).
     
    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:2004-001201-10
    Sponsor's Protocol Code Number:FEN-PPA-401
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-03-20
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2004-001201-10
    A.3Full title of the trial
    Comparison of transdermal fentanyl PCA and IV morphine PCA in the management of post-operative pain control.
    Comparación de fentanilo transdérmico PCA y morfina intravenosa PCA para el control del dolor postoperatorio
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparación de fentanilo transdérmico y morfina intravenosa en analgesia controlada por el paciente para el control del dolor postoperatorio.
    A.3.2Name or abbreviated title of the trial where available
    Euro-Trans study
    Euro-Trans
    A.4.1Sponsor's protocol code numberFEN-PPA-401
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorJanssen-Cilag EMEA Medical Affairs
    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 supportJanssen-Cilag EMEA Medical Affairs
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen-Cilag EMEA Medical Affairs
    B.5.2Functional name of contact pointSandra Waechter
    B.5.3 Address:
    B.5.3.1Street AddressTurnshoutseweg 30
    B.5.3.2Town/ cityBeerse
    B.5.3.3Post codeB-2340
    B.5.3.4CountryBelgium
    B.5.4Telephone number41417673432
    B.5.5Fax number41417673400
    B.5.6E-mailswaechte@jacch.jnj.com
    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 nameFENTANYL
    D.3.2Product code R004263
    D.3.4Pharmaceutical form Transdermal patch
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTransdermal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 1443-54-5
    D.3.9.3Other descriptive nameFENTANYL HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB21234
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number40 to 25
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Yes
    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 No
    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.2.5The 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
    D.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 57-27-2
    D.3.9.3Other descriptive nameMORPHINE
    D.3.9.4EV Substance CodeSUB03332MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number240
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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
    post-operative pain control
    Control del dolor postoperatorio
    E.1.1.1Medical condition in easily understood language
    Control del dolor postoperatorio
    E.1.1.2Therapeutic area Diseases [C] - Symptoms and general pathology [C23]
    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
    Aim of this study
    This study will evaluate the clinical use, safety and and ease of care of a Transdermal PCA system and morphine IV PCA for management of moderate to severe acute pain in post?operative subjects who have undergone elective major abdominal or orthopaedic surgery. Subjects are expected to require parenteral opioids for at least 24 hours post-operatively. As much as possible, management of all aspects of the care for the subject during hospital stay not directly related to analgesic management of post-operative pain will be in accordance with each study center's standard clinical practice.
    The primary objective of this study is to evaluate the clinical use of Transdermal PCA treatment and morphine IV PCA treatment for the management of moderate to severe post?operative pain in subjects who have undergone an elective major abdominal or orthopaedic procedure.
    E.2.2Secondary objectives of the trial
    · To assess pain control in both treatment groups, including the Subject?s and Physician?s Global Treatment Assessments,
    · To compare the Safety of Transdermal PCA system for pain management in this surgical population with the Safety of morphine IV PCA,
    · To explorate the impact on care procedures of the Transdermal PCA system and morphine IV PCA device, by means of validated Ease of Care Questionnaires, related to the subject, nursing staff and physical therapists.
    · To compare technical issues with both systems.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects must satisfy the following criteria to be enrolled in the study:
    1. Adult, age 18 or older, male or female;
    2. American Society of Anesthesiology (ASA) pre-operative physical status I, II, or III (Attachment 2);
    3. If the subject is female and of childbearing potential, she must have a negative pregnancy test after hospital admission, unless patient is undergoing hysterectomy;
    4. Subjects, after an elective major abdominal or orthopaedic procedure, who are expected to have moderate or severe pain requiring parenteral opioids for at least 24 hours after surgery;
    5. Subjects who are capable of understanding and cooperating with the requirements of the study and operating the Transdermal PCA system or the IV PCA device;
    6. Subjects who have signed and dated an informed consent to participate in the study during the pre-operative assessment;
    7. Subjects who have been admitted to the recovery room after general anesthesia, spinal anesthetic of < 4 hours duration of action or epidural anesthesia after an elective major abdominal or orthopaedic procedure and who expectedly suffer from moderate to severe pain and will require post-operative analgesia for at least 24 hours. Subjects with epidural or regional anesthesia 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, subjects with epidural or regional anesthesia must still qualify for needing IV PCA analgesia according to the local hospital standards;
    8. Subjects who are alert and breathing spontaneously for at least 30 minutes in the waking room; respiratory rate 10 to 24 breaths per minute; SpO2 ³90% (with or without supplemental oxygen), subjects must be able to answer questions and follow commands;
    9. Subjects with a pain score less than or equal to 4 out of 10 on a Numerical Rating Scale (NRS) after titration to comfort with IV morphine. In case of abdominal surgery, this should be measured five minutes after deep breathing and coughing;
    10. Subjects who are expected to remain hospitalized for at least 24 hours post-operatively.
    E.4Principal exclusion criteria
    Potential subjects who meet any of the following criteria will be excluded from participating in the study:
    1. Subjects with a history of allergy or hypersensitivity to fentanyl and/or morphine and/or an allergy/hypersensitivity to skin adhesives and/or cetylpyridinium chloride;
    2. Subjects who are known or suspected to be strong opioid dependent, or who have a too high a need for strong opioids;
    3. Subjects with a history of psychological opioid dependence before the start of the study, defined as meeting any of the criteria for substance dependence specified in Attachment 3;
    4. Subjects who are known or suspected to have abused any drug substance or alcohol (see Attachment 4);
    5. Subjects with chronic pain disorder (DSM-IV: F45.4);
    6. Subjects with active systemic skin disease or active local skin disease that precludes Transdermal PCA system application;
    7. Subjects known to have any of the following:
    · severe chronic obstructive respiratory symptoms,
    · susceptibility to present respiratory depression (possible synergistic effect associated with CNS drugs);
    · subjects with renal dysfunction;
    · subjects 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;
    - use of anti-depressants/anxiolytics is allowed provided that they were taken for the same indication before surgery;
    8. Women who are pregnant, breast feeding, or planning to breast feed within 7 days of last dose of study drug;
    9. Subjects 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. Subjects who have previously enrolled in a Transdermal PCA study;
    11. Subjects 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 waking room for shivering;
    12. Subjects who need very high doses of opioids to control their pain (more than 40 mg morphine/h) or more than 6 hours have elapsed since the subject arrived in the waking room;
    13. Subjects whose post-operative pain would normally be managed with oral or non-opioid analgesia during the first 24 hours;
    14. Subjects who are being treated in the intensive care unit;
    15. Subjects who will probably require additional surgical procedures within 72 hours;
    16. Subjects who are intubated or have a laryngeal mask airway (LMA) at the time of final screening assessments;
    17. Subjects 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 end point: The study is designed to demonstrate non-inferiority of Transdermal PCA versus morphine IV PCA treatment in subject?s global assessment of method of pain control during the first 24 hours post-surgery
    E.5.1.1Timepoint(s) of evaluation of this end point
    A las 24 horas tras cirugía mayor abdominal u ortopédica
    E.5.2Secondary end point(s)
    Objetivos secundarios:
    ? Evaluar el control del dolor en los dos grupos de tratamiento, incluyendo las Evaluaciones Globales del Tratamiento Realizadas por el Paciente y el Médico.
    ? Comparar la Seguridad del dispositivo de PCA Transdérmica frente a la Seguridad de la PCA-IV con morfina en el manejo del dolor de esta población quirúrgica.
    ? Investigar la influencia del dispositivo de PCA Transdérmica frente a PCA-IV con morfina en términos de atención al paciente, a través de los Cuestionarios sobre Facilidad de Prestación de Cuidados Médicos validados que serán cumplimentados por los pacientes, el personal de enfermería y los fisioterapeutas.
    ? Comparar los aspectos técnicos de ambos dispositivos.
    E.5.2.1Timepoint(s) of evaluation of this end point
    A las 24 horas tras cirugía mayor abdominal u ortopédica
    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) 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 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.8.2.4Number of treatment arms in the trial2
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA45
    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 No
    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
    (Please, refers to protocol appropiate section)
    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 months7
    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 months11
    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.1.2.1Number of subjects for this age range: 520
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 130
    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 state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 650
    F.4.2.2In the whole clinical trial 650
    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)
    (Please, see protocol)
    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 Decision2004-08-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2004-05-28
    P. End of Trial
    P.End of Trial StatusOngoing
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2020 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA