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    Summary
    EudraCT Number:2014-004088-19
    Sponsor's Protocol Code Number:TCI-PCA-002
    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:2014-11-20
    Trial 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 number2014-004088-19
    A.3Full title of the trial
    Postoperative pain treatment after elective cardiac surgery using patient-controlled target-controlled infusion (TCI-PCA) with hydromorphone vs. patient-controlled analgesia (PCA) with morphine
    Postoperative Schmerztherapie nach elektiven kardiochirurgischen Eingriffen mittels patientenkontrollierter “Target-controlled Infusion” (TCI-PCA) mit Hydromorphon versus patientenkontrollierter Analgesie (PCA) mit Morphin
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment of postoperative pain after planned cardiac surgery using hydromorphone patient-controlled analgesia with target concentrations in blood compared to morphine patient-controlled analgesia
    A.3.2Name or abbreviated title of the trial where available
    TCI-PCA Hydromorphon vs. PCA Morphin
    A.4.1Sponsor's protocol code numberTCI-PCA-002
    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 SponsorUniversitätsklinikum Erlangen
    B.1.3.4CountryGermany
    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 supportBundesministerium für Bildung und Forschung
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversitätsklinikum Erlangen
    B.5.2Functional name of contact pointAnästhesiologische Klinik
    B.5.3 Address:
    B.5.3.1Street AddressKrankenhausstraße 12
    B.5.3.2Town/ cityErlangen
    B.5.3.3Post code91054
    B.5.3.4CountryGermany
    B.5.4Telephone number+4991318542363
    B.5.5Fax number+4991318539161
    B.5.6E-mailchristian.jeleazcov@kfa.imed.uni-erlangen.de
    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 Palladon
    D.2.1.1.2Name of the Marketing Authorisation holderMundipharma GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 Solution for injection
    D.3.4.1Specific paediatric formulation No
    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 INNHYDROMORPHONE HYDROCHLORIDE
    D.3.9.1CAS number 71-68-1
    D.3.9.3Other descriptive nameHYDROMORPHONE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB02573MIG
    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) 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.IMP: 2
    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.2.1.2Country which granted the Marketing AuthorisationGermany
    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 Solution for injection
    D.3.4.1Specific paediatric formulation No
    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 HYDROCHLORIDE
    D.3.9.1CAS number 52-26-6
    D.3.9.3Other descriptive nameMORPHINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB14596MIG
    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) 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
    Postoperative pain treatment after elective cardiac surgery
    Postoperative Schmerztherapie nach elektiven kardiochirurgischen Eingriffen
    E.1.1.1Medical condition in easily understood language
    Pain treatment after planned cardiac surgery
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10036236
    E.1.2Term Postoperative pain relief
    E.1.2System Organ Class 100000004865
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Comparison in analgetic efficiency of hydromorphone TCI-PCA vs. conventional morphine PCA in the early postoperative period.
    Vergleich der Hydromorphon-TCI-PCA vs. konventioneller Morphin-PCA in der frühen postoperativen Phase hinsichtlich der analgetischen Effizienz.
    E.2.2Secondary objectives of the trial
     Comparison of amount and consumption profiles between treatment groups.
     Peak concentrations of hydromorphone and morphine under TCI-PCA and conventional PCA, respectively.
     Description and comparison of safety and tolerability of early postoperative pain treatment using hydromorphone TCI-PCA vs. conventional morphine PCA.
     Vergleich der verbrauchte Mengen und Anforderungsprofile zwischen den beiden Behandlungsgruppen.
     Spitzenkonzentrationen von Hydromorphon und Morphin unter TCI-PCA bzw. konventioneller PCA.
     Beschreibung und Vergleich der Sicherheit und Verträglichkeit der frühen postoperativen Schmerztherapie mittels Hydromorphon-TCI-PCA vs. konventioneller Morphin-PCA.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Written informed consent.
    Age between 40 and 85 years, both genders.
    Scheduled for elective cardiac surgery involving thoracotomy and subsequent ICU stay.
    Schriftliche Zustimmung zur Studienteilnahme.
    Männliche oder weibliche Person im Alter von 40 bis 85 Jahren.
    Elektiver kardiochirurgischer Eingriff mit Thorakotomie und anschließendem Aufenthalt auf der Intensivstation.
    E.4Principal exclusion criteria
    Administration of other analgesics or sedatives, if not administered in stable dosage for at least 14 days or if not used for premedication and surgery.
    Administration of hydromorphone or morphine in the period between secreening and admission to the ICU.
    Severe hepatic or renal impairment in medical history.
    BMI ≥35 kg/m².
    ASA ≥4.
    Einnahme von Analgetika oder Sedativa, soweit sie nicht seit mindestens 14 Tagen in unveränderter Dosierung oder zur Prämedikation oder Durchführung des kardiochirurgischen Eingriffs angewendet werden.
    Gabe von Hydromorphon oder Morphin im Zeitraum zwischen Screening-Termin (Visite 1, Tag -3 bis -1) bis zu Beginn von Visite 2 (Tag 1).
    BMI ≥35 kg/m².
    ASA ≥4.
    E.5 End points
    E.5.1Primary end point(s)
    Comparison of the course over time of the NRS-11 values between the treatment groups.
    Vergleich des Verlaufs der NRS-11-Werte zwischen den beiden Behandlungsgruppen.
    E.5.1.1Timepoint(s) of evaluation of this end point
    During treatment visit (visit 2).
    Während der Behandlungsphase (Visite 2).
    E.5.2Secondary end point(s)
    Comparison of amounts of hydromrophone and morphine administered by TCI-PCA and conventional PCA, respectively, in morphine equivalents.
    Comparison of frequency and amount of analgetic rescue medication between treatment groups.
    CMax of hydromorphone and morphine using TCI-PCA and conventional PCA, respectively.
    Comparison of number of AEs and SAEs between treatment groups.
    Comparison of frequency and duration of MOAA/s values ≤3 between treatment groups.
     Vergleich der applizierten Mengen an Hydromorphon und Morphin unter TCI-PCA bzw. konventioneller PCA in Morphinäquivalenten.
     Vergleich der Häufigkeit und Menge an analgetischer Rescue-Medikation zwischen den beiden Behandlungsgruppen.
     CMax von Hydromorphon und Morphin unter TCI-PCA bzw. konventioneller PCA nach entsprechender Normierung auf dem beobachteten Wertintervall.
     Vergleich der Zahl von AEs und SAEs zwischen den beiden Behandlungsgruppen.
     Vergleich der Häufigkeit und Dauer von MOAA/S-Werten ≤3 zwischen den beiden Behandlungsgruppen.
    E.5.2.1Timepoint(s) of evaluation of this end point
    During treatment visit (visit 2).
    Während der Behandlungsphase (Visite 2).
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind Yes
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 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
    LVLS
    Letzte Visite des letzten Studienteilnehmers
    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 months0
    E.8.9.1In the Member State concerned days0
    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.1.2.1Number of subjects for this age range: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 No
    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 state50
    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)
    Standard care after cardiac surgery
    Standardtherapie nach kardiochirurgischem Eingriff
    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 Decision2014-12-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-10-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-12-01
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