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    Summary
    EudraCT Number:2018-004351-20
    Sponsor's Protocol Code Number:01122018v2
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-12-11
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2018-004351-20
    A.3Full title of the trial
    Intraoperative methadone in same-day hysterectomy: a prospective, double-blind, randomised controlled trial
    Intraoperativt metadon til sammedags hysterektomi: et prospektivt, dobbelt blindet randomiseret kontrolleret forsøg
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pain after hysterectomy: a blinded randomised investigation
    Smerter efter fjernelse af livmoderen: en blindet randomiseret undersøgelse.
    A.3.2Name or abbreviated title of the trial where available
    Intraoperative methadone in same-day hysterectomy: a prospective, double-blind, randomised controlle
    Smerter efter fjernelse af livmoderen: en blindet randomiseret undersøgelse.
    A.4.1Sponsor's protocol code number01122018v2
    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 SponsorAarhus University Hospital
    B.1.3.4CountryDenmark
    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 supportThe Novo Nordisk Foundation
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAarhus University Hospital
    B.5.2Functional name of contact pointLone Nikolajsen
    B.5.3 Address:
    B.5.3.1Street AddressPalle Juul Jensens Boulevard 99
    B.5.3.2Town/ cityAarhus N
    B.5.3.3Post code8200
    B.5.3.4CountryDenmark
    B.5.4Telephone number004578464317
    B.5.6E-maillone.nikolajsen@clin.au.dk
    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 Methadon Streuli Sol Inj 10mg/ml 10AMPS 1ML
    D.2.1.1.2Name of the Marketing Authorisation holderStreuli Pharma AG, Schweitz
    D.2.1.2Country which granted the Marketing AuthorisationSwitzerland
    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
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMETHADONE
    D.3.9.1CAS number 76-99-3
    D.3.9.4EV Substance CodeSUB08833MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number30
    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 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
    D.2.1.1.2Name of the Marketing Authorisation holderAmgros I/S
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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.3.2Product code N02AA01
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    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
    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 typeup to
    D.3.10.3Concentration number30
    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
    Same-day hysterectomy
    Hysterktomi
    E.1.1.1Medical condition in easily understood language
    Removal of the uterus
    Fjernelse af livmoderen
    E.1.1.2Therapeutic area Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10023692
    E.1.2Term Laparoscopically assisted hysterectomy
    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
    The aim of this study is to investigate the effect of a single dose of intravenous intraoperative methadone on postoperative opioid consumption, pain and side effects in patients scheduled for hysterectomy for benign indications. A single dose of intravenous intraoperative morphine will be used as an active comparator.
    Formålet med studiet er at undersøge effekten af en enkelt dosis af iv metadon givet intraoperativt på effekten af det postoperative opioid behov, smerte og bivirkninger hos patienter som skal have foretaget en hysterktomi pga benign indikation. En enkelt dosis af iv intraoperativt morfin anvendes som aktivt samligning.
    E.2.2Secondary objectives of the trial
    • Pain intensity (NRS, 0-10) at rest and coughing at 0.5, 1, 3, 6, 24, 48 and 72 hours after extubation
    • Patient satisfaction (NRS, 0-10) with pain management at 3 and 24 hours after extubation
    • Nausea and/or vomiting (PONV) on a 4 point Likert scale (none/mild/moderate/severe) at 6, 24 and 72 hours
    • Time from arrival to readiness for discharge from PACU and hospital (hours and minutes).
    • Level of sedation at observation at the PACU (Ramsay Sedation Scale [20] at 0.5, 1 and 3 hours after extubation)
    • Any adverse events during observation at the PACU:
    o Hypoventilation (respiratory rate < 10/minutes)
    o Hypoxemia (peripheral oxygen saturation < 90%)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    All patients scheduled for elective laparoscopic hysterectomy for benign indications are screened for inclusion
    E.4Principal exclusion criteria
    Patients with one of the following criteria are excluded:
    • American Society of Anaesthesiologists (ASA) physical status IV or V [21]:
    • Prolonged QT-interval assessed by electrocardiogram (> 440 milliseconds).
    • Existing treatment with medications prolonging the QT-interval (see appendix for details)
    • Hysterectomy due to malignancy or acute bleeding disorders
    • Allergy to study drugs
    • Preoperative daily use of opioids or
    • Inability to provide informed consent

    Secondary exclusion criteria:
    • Intraoperative conversion to open surgery.
    E.5 End points
    E.5.1Primary end point(s)
    Primary outcomes:
    • Opioid consumption at 24 hours (mean cumulative opioid consumption)
    • Opioid consumption at 6 hours after extubation (mean cumulative opioid consumption)
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 and 24 hours after extubation.
    E.5.2Secondary end point(s)
    Secondary outcomes:
    • Pain intensity (NRS, 0-10) at rest and coughing at 0.5, 1, 3, 6, 24, 48 and 72 hours after extubation
    • Patient satisfaction (NRS, 0-10) with pain management at 3 and 24 hours after extubation
    • Nausea and/or vomiting (PONV) on a 4 point Likert scale (none/mild/moderate/severe) at 6, 24 and 72 hours
    • Time from arrival to readiness for discharge from PACU and hospital (hours and minutes).
    • Level of sedation at observation at the PACU (Ramsay Sedation Scale [20] at 0.5, 1 and 3 hours after extubation)
    • Any adverse events during observation at the PACU:
    o Hypoventilation (respiratory rate < 10/minutes)
    o Hypoxemia (peripheral oxygen saturation < 90%)
    E.5.2.1Timepoint(s) of evaluation of this end point
    0.5, 1, 3, 6, 24, 48 and 72 hours after extubation and 4 months after surgery.
    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 No
    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 No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    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
    Last visit, last patient.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months8
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 26
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2018-12-11. Yes
    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 state126
    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)
    None
    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 Decision2019-02-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-01-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-10-06
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