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    Summary
    EudraCT Number:2011-003648-31
    Sponsor's Protocol Code Number:PKPDHM-001
    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:2011-08-18
    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 number2011-003648-31
    A.3Full title of the trial
    Pharmacokinetic-pharmacodynamic modeling of the postoperative pain sensation during patient-controlled analgesia with target-controlled infusion of Hydromorphone, taking into account the interaction with intraoperatively administered Sufentanil for elective cardiac surgery
    Pharmakokinetisch-pharmakodynamische Modellbildung der postoperativen Schmerzempfindung während patientengesteuerter Analgesie mit „Target-controlled Infusion“ von Hydromorphon unter Berücksichtigung der Interaktion mit intraoperativ verabreichtem Sufentanil bei elektiven kardiochirurgischen Eingriffen
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Generation of a model for the adaption of the postoperative pain therapy with the strong analgesic, hydromorphone, after planned open heart surgery, during which the strong analgesic, sufentanil, was used
    Erstellung eines Modells zur Anpassung der postoperativen Schmerzbehandlung mit dem starken Schmerzmittel Hydromorphon nach geplanten Operationen am offenen Herz, bei denen das starke Schmerzmittel Sufentanil eingesetzt wurde
    A.3.2Name or abbreviated title of the trial where available
    PkPd Hydromorphon-Sufentanil
    A.4.1Sponsor's protocol code numberPKPDHM-001
    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 code91052
    B.5.3.4CountryGermany
    B.5.4Telephone number+4991318542363
    B.5.5Fax number+4991318539161
    B.5.6E-mailchristian.jeleazcov@kfa.imed.uk-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 Sufenta 50µg/ml Injektionslösung
    D.2.1.1.2Name of the Marketing Authorisation holderJANSSEN-CILAG 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 INNSUFENTANIL CITRATE
    D.3.9.1CAS number 60561-17-3
    D.3.9.4EV Substance CodeSUB04616MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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.2.1.1.1Trade name Palladon Injekt 10mg
    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.3.9.4EV 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.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
    Pain therapy after elective cardiac surgery
    Schmerztherapie nach elektiven kardiochirurgischen Eingriffen
    E.1.1.1Medical condition in easily understood language
    Pain treatment after planned open heart surgery
    Schmerzbehandlung nach geplanten Operationen am offenen Herz
    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 14.0
    E.1.2Level LLT
    E.1.2Classification code 10036236
    E.1.2Term Postoperative pain relief
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Pharmacokinetic-pharmacodynamic modeling for the interaction of sufentanil (administered during surgery via target-controlled infusion) and hydromorphone (administered after surgery as patient-controlled analgesia via target-controlled infusion) in the early postoperative period
    Pharmakokinetisch-pharmakodynamische Modellbildung für die Interaktion von intraoperativ verabreichtem Sufentanil (mittels Target-controlled Infusion) und postoperativ appliziertem Hydromorphon (als Patienten-kontrollierte Analgesie mittels Target-controlled Infusion) in der frühen postoperativen Phase
    E.2.2Secondary objectives of the trial
    • Description and comparison of antinociception caused by sufentanil and hydromorphone in the early postoperative period through indicators assessed in both treatment arms
    • Description and comparison of safety and tolerability of postoperative pain treatment with hydromorphone TCI, TCI-PCA and PCA after intraoperative sufentanil TCI in both treatment arms
    • Identification of the minimal hydromorphone target plasma concentration appropriate for postoperative pain treatment
    • Beschreibung und Vergleich der durch Sufentanil und Hydromorphon hervorgerufenen Antinociception in der frühen postoperativen Phase durch Erfassung von Indikatoren in den beiden Behandlungsgruppen
    • Beschreibung und Vergleich der Sicherheit und Verträglichkeit der postoperativen Schmerztherapie unter TCI, TCI-PCA und konventioneller PCA mit Hydromorphon nach intraoperativer Anwendung einer Sufentanil-TCI in den beiden Behandlungsgruppen
    • Bestimmung der für die postoperative Schmerztherapie geeigneten minimalen Plasmazielkonzentration von Hydromorphon
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Written informed consent
    Ability to understand the nature of patient-controlled analgesia and other study-specific procedures
    Elective cardiac surgery with thoracotomy and subsequent stay in the intensive care unit
    Schriftliche Einverständniserklärung
    Fähigkeit, das Wesen der Patienten-kontrollierten Analgesie und weiterer studienspezifischer Maßnahmen zu verstehen
    Elektiver kardiochirurgischer Eingriff mit Thorakotomie und anschließendem Aufenthalt auf der Intensivstation
    E.4Principal exclusion criteria
    Use of MAO inhibitors in the last 14 days
    Chronic alcoholism or drug addiction in medical history
    Severe obstuctive or restrictive pulmonal disorders in medical history
    Severe hepatic and renal disorders in medical history
    Hypothyroidism, prostate hyperplasia, pancreatitis, biliary or renal colic in medical history
    ASA IV
    Pregnant or nursing females
    Anwendung von MAO-Hemmern in den vergangenen 14 Tagen
    Dhronischer Alkoholabusus oder Drogenabhängigkeit in der Anamnese
    Schwerwiegende obstruktive oder restriktive Lungenerkrankungen in der Anamnese
    Schwerwiegende Leber- und Nierenfunktionsstörungen in der Anamnese
    Hypothyreose, Prostatahypertrophie, Nebenniereninsuffizienz, Pankreatitis, Gallen- oder Nierenkoliken in der Anamnese
    ASA IV
    Schwangere und stillende Mütter
    E.5 End points
    E.5.1Primary end point(s)
    • Course and comparison of the course of the Numerical Rating Scale-11 scores over time between the two treatment arms
    • Plasma concentrations of sufentanil and hydromorphone at predefined timepoints for both treatment arms
    • Verlauf und Vergleich des Verlaufs der Numerical Rating Scale 11-Werte über den Untersuchungszeitraum in den beiden Behandlungsgruppen
    • Plasmakonzentrationen von Sufentanil und Hydromorphon zu den Abnahmezeitpunkten getrennt nach Behandlungsgruppen
    E.5.1.1Timepoint(s) of evaluation of this end point
    Visits 2 and 3 (Day 1 and 2/3)
    Visiten 2 und 3 (Tag 1 und 2/3)
    E.5.2Secondary end point(s)
    • Amount of sufentanil administered during sufentanil TCI for both treatment arm
    • Amount of hydromorphone administered during hydromorphone TCI, TCI-PCA and PCA for both treatment arms
    • Comparison of concentrations of sufentanil and hydromorphone at half-maximal effect EC50 between treatment arms
    • Pharmacokinetics of sufentanil and hydromorphone for both treatment arms
    • Frequency and incidence of AEs and SAEs in both treatment groups
    • MOAA/S at predefined timepoints in both treatment arms
    • Verabreichte Menge von Sufentanil während der Sufentanil-TCI getrennt nach Behandlungsgruppen
    • Verabreichte Menge von Hydromorphon während der Hydromorphon-TCI, der Hydromorphon-TCI-PCA und der konventionellen Hydromorphon-PCA getrennt nach Behandlungsgruppen
    • Vergleich der Konzentration zum halbmaximalen Effekt EC50 von Sufentanil und Hydromorphon zwischen den beiden Behandlungsgruppen
    • Pharmakokinetische Parameter von Sufentanil und Hydromorphon getrennt nach Behandlungsgruppen.
    • Anzahl und Inzidenz von AEs und SAEs getrennt nach Behandlungsgruppen
    • MOAA/S zu den Bestimmungszeitpunkten getrennt nach Behandlungsgruppen
    E.5.2.1Timepoint(s) of evaluation of this end point
    Visits 2, 3 and 4 (Day 1, 2/3 and 3/4)
    Visiten 2, 3 und 4 (Tag 1, 2/3 und 3/4)
    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 Yes
    E.6.7Pharmacodynamic Yes
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Verschiedene Dosierungen der beiden Prüfpräparate
    Different doses of the two IMPs
    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
    Last subject last visit
    Letzte Visite letzter Studienteilnehmer
    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 months11
    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 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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 of care after elective cardiac surgery
    Standardbehandlung nach elektiven kardiochirurgischen Eingriffen
    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 Decision2011-09-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-11-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-09-10
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