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    Summary
    EudraCT Number:2019-001725-27
    Sponsor's Protocol Code Number:KKSH152
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-05-29
    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 number2019-001725-27
    A.3Full title of the trial
    A randomized, open, three-arm comparative study of modern methods of postoperative pain therapy in patients with knee endoprostheses.
    Eine randomisierte, offene dreiarmige Vergleichsstudie bestehender moderner Verfahren der postoperativen Schmerztherapie bei Patienten mit Knieendoprothesen
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A randomized, open, three-arm comparative study of modern methods of postoperative pain therapy in patients with knee endoprostheses.
    Eine randomisierte, offene dreiarmige Vergleichsstudie bestehender moderner Verfahren der postoperativen Schmerztherapie bei Patienten mit Knieendoprothesen
    A.3.2Name or abbreviated title of the trial where available
    SchmerzKEP
    A.4.1Sponsor's protocol code numberKKSH152
    A.5.4Other Identifiers
    Name:DRKSNumber:DRKS00017468
    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 SponsorMartin-Luther-Universität Halle-Wittenberg
    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 supportUniversitätsklinikum Halle
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversitätsklinikum Halle
    B.5.2Functional name of contact pointPrincipal Investigator
    B.5.3 Address:
    B.5.3.1Street AddressErnst-Grube-Strasse 40
    B.5.3.2Town/ cityHalle (Saale)
    B.5.3.3Post code06120
    B.5.3.4CountryGermany
    B.5.4Telephone number+493455571733
    B.5.5Fax number+493455575912
    B.5.6E-maillilit.floether@uk-halle.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 Zalviso 15 Mikrogramm Sublingualtabletten
    D.2.1.1.2Name of the Marketing Authorisation holderGrünenthal 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 Sublingual tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSublingual 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 microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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 Oxycodon
    D.2.1.1.2Name of the Marketing Authorisation holderseveral generics
    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.3.1Product nameOxycodone
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOxycodone hydrochloride
    D.3.9.1CAS number 124-90-3
    D.3.9.3Other descriptive nameOXYCODONE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB03583MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number10 to 20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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: 3
    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 Oxycodon
    D.2.1.1.2Name of the Marketing Authorisation holderseveral generics
    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.3.1Product nameOxycodone
    D.3.4Pharmaceutical form Prolonged-release tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOxycodone hydrochloride
    D.3.9.1CAS number 124-90-3
    D.3.9.3Other descriptive nameOXYCODONE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB03583MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number10 to 20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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: 4
    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 Ropivacain
    D.2.1.1.2Name of the Marketing Authorisation holderseveral generics
    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.3.1Product nameRopivacaine
    D.3.4Pharmaceutical form Solution for infusion
    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 INNROPIVACAINE HYDROCHLORIDE
    D.3.9.1CAS number 84057-95-4
    D.3.9.3Other descriptive nameROPIVACAINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB04264MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 therapy after implantation of a knee endoprosthesis
    Postoperative Schmerztherapie nach Implantation einer Knieendoprothese
    E.1.1.1Medical condition in easily understood language
    Pain therapy after total knee replacement
    Schmerztherapie nach dem Einsetzen eines künstlichen Kniegelenkes
    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 21.1
    E.1.2Level PT
    E.1.2Classification code 10036276
    E.1.2Term Postoperative analgesia
    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
    The primary objective is to examine the influence of three established postoperative pain therapy procedures on postoperative pain intensity after the implantation of a knee endoprosthesis. The postoperative pain is measured on the 3rd postoperative day at rest and under strain.
    Primäres Ziel ist die Prüfung des Einflusses von drei etablierten Verfahren der postoperativen Schmerztherapie auf die Schmerzstärke postoperativ nach dem Einsatz einer Knieendoprothese. Hierzu werden die postoperativen Schmerzen am 3. postoperativen Tag in Ruhe und unter Belastung gemessen.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to investigate the influence of the three interventions on patient satisfaction, mobilization, pain chronification and requierement of analgesics. Furthermore, the quality of life, the inflammation parameters and the duration of the inpatient hospitalization will be investigated.
    Die sekundären Ziele sind die Untersuchung des Einflusses der Interventionen auf die Patientenzufriedenheit, die Mobilisierbarkeit, Schmerzchronifizierung und den Analgetikabedarf. Weiterhin sollen die Lebensqualität, die Entzündungsparameter und die Dauer des stationären Aufenthaltes untersucht werden.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age: from 18 years
    - Indication for implantation of a unilateral knee endoprosthesis
    - Patients with (American Society of Anesthesiologists) ASA Score 1 to 3
    - Signed informed consent
    - Alter: ab 18 Jahre
    - Indikation zur Implantation einer unilaterale Knieendoprothese
    - Patienten mit (American Society of Anesthesiologists) ASA-Score 1 bis 3
    - Unterschriebene Einwilligungserklärung
    E.4Principal exclusion criteria
    - other endoprosthesis on a lower extremity with NRS > 4
    - Patients with a previous spinal surgery
    - inflammatory bowel diseases
    - permanent intake of opioids WHO stage III (more than 6 weeks before the planned surgery)
    - clinically relevant Obstructive Sleep Apnea Syndrome
    - disorders of bone marrow function (e.g. after cytostatic treatment) or diseases of the haematopoietic system
    - genetically determined glucose-6-phosphate dehydrogenase deficiency
    - acute intermittent hepatic porphyria
    - serious impairment of lung function, clinically relevant COPD, Cor pulmonale
    - severe bronchial asthma, severe coagulation disorders or other contraindications to the development of peripheral nerve block
    - active peptic ulcers or gastrointestinal (GI) bleeding
    - allergies or intolerances to sufentanil and oxycodone
    - Allergies or hypersensitivities to amide-type local anesthetics
    - Allergies or hypersensitivities to the active ingredients of parecoxib and metamizole
    - Decompensated or inadequately treated heart failure (NYHA III to IV), clinically newly proven coronary artery disease within the last 6 months, peripheral arterial occlusive disease and/or cerebrovascular events within the last 6 months
    - considerable hypotension and bradycardia as well as severe prostate hyperplasia and biliary tract diseases
    - Infection at the injection site for regional anesthesia
    - Cirrhosis of the liver Child-Pugh Grade B and C
    - GFR < 30
    - pregnant or breastfeeding patients
    - women capable of giving birth without contraception; all measures with a Pearl index <1 are regarded as reliable contraception, other methods such as natural contraception are regarded as inadequate contraception.
    - Refusal of aaspiration by the patient
    - Patients unable to consent
    - Participation in another drug study
    - officially and/or legally accomodated persons
    - Andere Kunstgelenke an der unteren Extremität mit NRS > 4
    - Patienten nach stattgehabter Wirbelsäulen-OP
    - entzündliche Darmerkrankungen
    - dauerhafte Einnahme von Opioiden WHO Stufe III (länger als 6 Wochen vor der ge-planten Operation)
    - Klinisch relevantes obstruktives Schlaf Apnoe Syndrom
    - Störungen der Knochenmarkfunktion (z. B. nach Zytostatikabehandlung) oder Erkrankungen des hämatopoetischen Systems
    - genetisch bedingter Glukose-6-Phosphat-Dehydrogenasemangel
    - akute intermittierende hepatische Porphyrie
    - schwerwiegende Beeinträchtigung der Lungenfunktion, Klinisch relevante COPD, Cor pulmonale
    - schweres Bronchialasthma, schwere Gerinnungsstörungen oder andere Kontraindikationen gegen die Anlage einer peripheren Nervenblockade
    - aktive peptische Ulzera oder gastrointestinale (GI) Blutungen
    - Allergien oder Unverträglichkeiten gegen Sufentanil und Oxycodon
    - Allergien oder Überempfindlichkeiten gegen Lokalanästhetika vom Amidtyp
    - Allergien oder Überempfindlichkeiten gegen die Wirkstoffe von Parecoxib und Metamizol
    - Dekompensierte oder nicht ausreichend therapierte Herzinsuffizienz (NYHA III bis IV), klinisch neu gesicherte koronare Herzkrankheit, in den letzten 6 Monaten bzw. periphere arterielle Verschlusskrankheit und/ oder zerebrovaskuläre Ereignisse in den letzten 6 Monaten
    - erhebliche Hypotonie und Bradykardieneigung sowie schwer-wiegende Prostatahyperplasie und Gallenwegserkrankungen
    - Infektion an der Einstichstelle für die Regionalanästhesie
    - Leberzirrhose Child-Pugh Grad B und C
    - GFR < 30
    - Schwangere oder stillende Patientinnen
    - gebärfähige Frauen ohne Kontrazeption; als zuverlässige Kontrazeption gelten alle Maßnahmen mit einem Pearl-Index <1, andere Methoden wie z.B. natürliche Verhütung wird als nicht ausreichende Kontrazeption angesehen.
    - Ablehnung einer Punktion durch den Patienten
    - Nicht einwilligungsfähige Patienten
    - Teilnahme an einer anderen Arzneimittelstudie
    - behördlich und gerichtlich untergebrachte Personen
    E.5 End points
    E.5.1Primary end point(s)
    Postoperative pain on the 3rd postoperative day at rest and under strain. The pain intensity will be assessed by the patient on the basis of a verbal numerical rating scale (NRS) from 0 (no pain) to 10 (maximum imaginable pain).
    Postoperativen Schmerzen am 3. postoperativen Tag in Ruhe und unter Belastung. Die Schmerzintensität wird hierbei durch den Betroffenen anhand einer verbalen numerischen Ratingskala (NRS) von 0 (kein Schmerz) bis 10 (maximal vorstellbarer Schmerz) selbst eingeschätzt.
    E.5.1.1Timepoint(s) of evaluation of this end point
    3rd postoperative day
    3. postoperativer Tag
    E.5.2Secondary end point(s)
    - Postoperative pain (NRS) on the 1st and 2nd postoperative day
    - Patient contentment is determined on the basis of a questionnaire with eight questions about the general contentment with the pain therapy and the treatment team.
    - Mobilisation determined on the basis of the Forgotten Joint Score (FJS) and the Knee Society Rating. The FJS is determined by means of a questionnaire and checks the patient's perception of the endoprothesis in daily life. The Knee Society Clinical Rating System is an internationally recognized evaluation system with the aim of recording the knee joint's qualitatively and quantitatively measurable characteristics on the one hand and to address the functional aspects in the patient's daily life on the other. The first part of the evaluation system is the knee score, in which a maximum of 100 points can be achieved. It measures the criteria pain, range of motion and stability of the knee. The second part is the Function Score, which evaluates the walking distance and the patients' behaviour when climbing stairs.
    - Quality of life determined on the basis of the SF 12 questionnaire.
    - Possible systemic inflammatory reactions investigated by determining the inflammatory parameters BB, CRP, PCT, IL-6.
    - For the purpose of pain chronification, the pain intensity will be recorded by means of NRS and the analgesic requirement (additional analgesics, parallel or after completion of the treatment phase in hospital). Proportion of patients beeing discharged from hospital with continued pain therapy (recording of opioids separately from non-opioid analgesics) or who still require analgesics at the time of the follow up questioning.
    - Obstipation (stool frequency of <3×/week) and night sleep (by means of a 3-part rating scale; good night sleep, moderate night sleep, bad night sleep by means of a patient diary)
    - Safety of the three intervention schemes through the systematic recording of all adverse events.
    - Postoperative Schmerzen (NRS) am 1. und 2. postoperativen Tag
    - Patientenzufriedenheit ermittelt anhand eines Fragebogens mit acht Fragen zur allgemeinen Zufriedenheit mit der Schmerztherapie und dem Behandlungsteam
    - Mobilisierbarkeit ermittelt anhand anhand des Forgotten Joint Score (FJS) sowie dem Knee Society Rating. Der FJS wird mittels Fragebogen erhoben und dient zur Überprüfung der Wahrnehmung des Kunstgelenkes durch den Patienten im täglichen Leben. Beim Knee Society Clinical Rating System handelt es sich um ein international anerkanntes Bewertungssystem mit dem Ziel, das Kniegelenk zum einen in seinen qualitativ bzw. quantitativ messbaren Eigenschaften zu erfassen und zum anderen auf die funktionellen Aspekte im täglichen Leben des Patienten einzugehen. Der erste Teil des Bewertungssystems ist der Knee Score, bei dem maximal 100 Punkte zu erreichen sind. Er erfasst die Kriterien Schmerz, Bewegungsumfang sowie die Stabilität des Knies. Der zweite Teil ist der Function Score, welcher die Gehstrecke und das Verhalten der Patienten beim Treppen-steigen evaluiert.
    - Lebensqualität ermittelt anhand des SF 12 – Fragebogen.
    - Mögliche systemische Entzündungsreaktion anhand der Bestimmung der Entzündungsparameter BB, CRP, PCT, IL-6.
    - Zur Schmerzchronifizierung werden die Schmerzstärke mittels NRS sowie der Analgetikabedarf erfasst (zusätzliche Analgetika, parallel oder nach Abschluss der Behandlungsphase im Krankenhaus). Anteil an Patienten, der mit einer fortgesetzten Schmerztherapie (Erfassung Opioide getrennt von Nicht-Opioid-Analgetika) aus dem Krankenhaus entlassen werden muss, bzw. zum Zeitpunkt Nachbefragung noch Analgetika benötigen.
    - Obstipation (Stuhlfrequenz von <3×/Woche) und Nachtschlaf (mittels 3er Rating Skala; guter Nachtschlaf, mäßiger Nachtschlaf, schlechter Nachtschlaf mittels Patiententagebuch)
    - Sicherheit der drei Interventionsschemata anhand der systematischen Erhebung aller unerwünschten Ereignisse.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Postoperative pain (NRS) on the 1st and 2nd postoperative day
    - Patient contentment at the end of the inpatient stay
    - Mobility and quality of life at the end of inpatient stay and 3, 6 and 12 months after discharge from hospital
    - Systemic inflammatory reaction: 1st, 2nd and 4th postoperative day, day of discharge from hospital and 3, 6 and 12 months after discharge from hospital
    - Pain chronification: day of discharge from hospital and 3, 6 and 12 months after discharge
    - Obstipation, night sleep: during the entire inpatient stay
    Safety, AEs: during the entire inpatient stay up to the 5th postoperative day, in case of suspicion of relationship with the study medication beyond this period
    - Postoperative Schmerzen (NRS) am 1. und 2. postoperativen Tag
    - Patientenzufriedenheit am Ende des stationären Aufenthaltes
    - Mobilisierbarkeit und Lebensqualität am Ende des stationären Aufenthaltes sowie 3, 6 und 12 Monate nach Entlassung aus dem Krankenhaus
    - Systemische Entzündungsreaktion: 1., 2. und 4. postoperativen Tag, Tag der Entlassung aus dem Krankenhaus sowie 3, 6 und 12 Monate nach Entlassung aus dem Krankenhaus
    - Schmerzchronifizierung: Tag der Entlassung aus dem Krankenhaus sowie 3, 6 und 12 Monate nach Entlassung
    - Obstipation, Nachtschlaf: während des gesamten stationären Aufenthaltes
    Sicherheit, AEs: während des gesamten stationären Aufenthaltes bis zum 5. postoperativen Tag, bei Verdacht auf Zusammenhang mit der Studienmedikation darüber hinaus
    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.8.2.4Number of treatment arms in the trial3
    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 Studienvisite des letzten Patienten.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 80
    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 state120
    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)
    After study treatment has been terminated, post trial treatment will not differ from the expected normal treatment of that condition and will depends on ivestigator´s and patient's choice.
    Nach Ende der Studientherapie wird sich die weitere Behandlung nicht vom üblichen Vorgehen im Rahmen dieses Krankheitsbildes unterscheiden und vom behandelnden Arzt und dem Patienten individuell festgelegt.
    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 Decision2019-10-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-10-24
    P. End of Trial
    P.End of Trial StatusOngoing
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