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    Summary
    EudraCT Number:2022-001857-22
    Sponsor's Protocol Code Number:Methadone-010922
    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:2022-07-23
    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 number2022-001857-22
    A.3Full title of the trial
    Perioperative Methadone for ameliorating postoperative pain and reduction in postoperative opioid consumption in hip fracture patients – Dosage adjusting pilot-study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Methadone as pain medication during surgery for hip fractures. – Dosage adjusting study.
    A.3.2Name or abbreviated title of the trial where available
    Meta-hip
    A.4.1Sponsor's protocol code numberMethadone-010922
    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 SponsorSygehus Sønderjylland, Orthopedic department
    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 supportSygehus Sønderjylland
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSygehus Sønderjylland
    B.5.2Functional name of contact pointOrthopedic department
    B.5.3 Address:
    B.5.3.1Street AddressKresten philipsensvej 15
    B.5.3.2Town/ cityAabenraa
    B.5.3.3Post code6200
    B.5.3.4CountryDenmark
    B.5.4Telephone number4530244740
    B.5.6E-mailkevin.heeboll.nygaard3@rsyd.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
    D.2.1.1.2Name of the Marketing Authorisation holderStreuli Pharma AG, 8730 Uznach.
    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 Solution for injection
    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.3.8INN - Proposed INN788
    D.3.9.1CAS number 1095-90-5
    D.3.9.4EV Substance CodeSUB03203MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.10 to 0.20
    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
    Hip fractures
    E.1.1.1Medical condition in easily understood language
    Patients with a broken hip
    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 20.1
    E.1.2Level LLT
    E.1.2Classification code 10068399
    E.1.2Term Trochanteric femoral fracture
    E.1.2System Organ Class 100000004863
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 25.0
    E.1.2Level LLT
    E.1.2Classification code 10086938
    E.1.2Term Pertrochanteric femoral fracture
    E.1.2System Organ Class 100000004863
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 25.0
    E.1.2Level LLT
    E.1.2Classification code 10086939
    E.1.2Term Intertrochanteric femoral fracture
    E.1.2System Organ Class 100000004863
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10017284
    E.1.2Term Fractured femoral neck
    E.1.2System Organ Class 100000004863
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10053653
    E.1.2Term Femur fracture subtrochanteric
    E.1.2System Organ Class 100000004863
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objective is to investigate whether doses greater than 0.10 mg/kg are tolerated with no increased risk of respiratory depression, side-effects, or prolonged stay in the post anesthesia care unit (PACU). This is to ensure that the doses used in the literature are tolerated by the elderly and fragile.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients diagnosed with a hip fracture on x-rays in the emergency department (collum femoris fractures, pertrochanteric fractures and subtrocantheric fractures)
    2. Age ≥ 60 years.
    3. Patients must be able to reliably assess their level of pain using the VRS and be able to ask for supplementary analgesics if needed. 4. Patients must understand the information given and be able to read and speak Danish. 5. Patients must be able to give informed consent.
    E.4Principal exclusion criteria
    1. Polytrauma (defined as a trauma with one or more absolute indications for surgical intervention).
    2. Previous allergic reactions or hypersensitivity towards Methadone hydrochloride or Sodium Chloride.
    3. Health conditions preventing treatment, i.e. chronic obstructive pulmonary disease (Gold classification C+D), history with acute asthma attacks or atopic skin conditions, cor pulmonale, raised intracranial pressure or head injury, Pheochromocytoma, history with paralytic ileus, QT interval prolongation, myasthenia gravis, liver disorders or hypotension.
    4. Concurrent administration with MAO inhibitors or within 2 weeks of suspending treatment with these medicinal products.
    5. Concurrent administration of sedatives, e.g. Benzodiazepines or related drugs.
    6. Included in other studies (e.g., SENSE-trial).
    7. Known cognitive disorders e.g., dementia.
    8. Current drug addiction e.g., opioid addiction or intravenous addiction.
    - Female patients are not tested regarding pregnancy seeing that they are ≥ 60 years old.
    E.5 End points
    E.5.1Primary end point(s)
    Primary outcome: - Respiratory depression: Occurrence of a RF <10/min and SAT <94 % despite 4 liters of oxygen/min.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary outcome is evaluated throughout the study.
    E.5.2Secondary end point(s)
    Secondary outcomes:
    - Length of stay: The length of stay at the PACU will be measured as hours.
    - Need for antidote: The number of times administration of Naloxone was necessary.
    - Postoperative opioid consumption: The opioid consumption will be measured as a mean consumption of rescue medication within the first 6 hours after surgery, within the first 24 hours after surgery and within the first 72 hours after surgery.
    - Opioid-related side-effects: Opioid-related side-effects will be registered binomial as nausea and vomiting (PONV) at 6 and 24 hours as present or not.
    - Postoperative pain: Patients will be asked to assess pain intensity at the time of arrival from the post-anaesthesia care unit using the VRS. They will be asked to assess pain intensity again after 6, 24 and 72 hours postoperatively.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary outcomes are evaluated when the study is completed.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Prospective cohort study
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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
    The end of the trial is when the last patient has completed the final registration of adverse events 12 days after administration of Methadone.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    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) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 40
    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 Decision2022-09-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-08-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-04-04
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