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    Summary
    EudraCT Number:2014-000839-16
    Sponsor's Protocol Code Number:SM3-RS-2014
    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:2014-03-10
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2014-000839-16
    A.3Full title of the trial
    The effect of intraoperative ketamine on opioid consumption and pain after spine surgery in opioid-dependent patients
    Effekten af intraoperativ ketamin på opioid forbrug og smerter efter rygkirurgi hos opioidbehandlede patienter
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effect og ketamine og morphine consumption and pain after spine surgery in patients with a daily morphine use
    Virkningen af ketamin på morfin forbrug og smerter efter rygkirurgi hos patienter i daglig morfin behandling
    A.4.1Sponsor's protocol code numberSM3-RS-2014
    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 SponsorHovedOrtoCentret, Rigshospitalet
    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 supportglostrup hospital
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationglostrup hospital
    B.5.2Functional name of contact pointdepartment of anaesthesiology
    B.5.3 Address:
    B.5.3.1Street Addressnordre ringvej 57
    B.5.3.2Town/ cityglostrup
    B.5.3.3Post code2600
    B.5.3.4CountryDenmark
    B.5.4Telephone number004560926839
    B.5.6E-mailrikkevibeke@gmail.com
    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 s-ketamin
    D.2.1.1.2Name of the Marketing Authorisation holderpfizer
    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 names-ketamin
    D.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection/infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Postoperative pain
    Postoperative smerter
    E.1.1.1Medical condition in easily understood language
    Pain after surgery
    Smerter efter operation
    E.1.1.2Therapeutic area Body processes [G] - Physiological processes [G07]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10049124
    E.1.2Term Sedation during medical procedure
    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
    Total morphine consumption, other than the patients usual opioid use, 0-24 hours postoperatively, administered on as patient-controlled analgesia (PCA, bolus 2.5 mg, lockout 10 minutes)
    Det totale morfinforbrug, ud over patientens vanlige opioid, 0 - 24 timer postoperativt, administreret som patient-kontrolleret smertebehandling (PCA, bolus 2,5 mg, lockout 10 minutter)
    E.2.2Secondary objectives of the trial
    Pain score during active mobilisation, measured on a visual analogue scale (VAS), defined ad a standarised movement from recumbent position to sitting on the bedside at 2, 6, 12, 18 and 24 hours postoperatively, the worst pain from the movement is registered. Endpoint is AUC-VAS-mob (2-24 t) calculated from these measurements.
    Pain score during rest (VAS), at 2, 6, 12, 18 and 24 hours postoperatively. Endpoint is AUC-VAS-mob (2-24 t) calculated from these measurements.
    Degree of nausea 0-24 hours at time 2, 6, 12, 18 og 24 hours postoperatively.
    Number of episodes vomiting 0-24 hours, registered in periods 0-2, 2-6, 6-12, 12-18, 18-24 hours postoperatively.
    Use of ondansetron during the period 0-24 hours postoperatively .
    Degree of sedation 0-24 hours, at time 2, 6, 12, 18 og 24 hours postoperatively.
    Hallucinations and nightmares 0-24 hours postoperatively.
    Chronic pain and daily use of opioids assessed by questionnaire 6- and 12 months postoperatively.
    Smertescore under aktiv mobilisation, målt på visuel analog skala (VAS), defineret ved standardiseret bevægelse fra liggende stilling til siddende på sengekanten til tiden 2, 6, 12, 18 og 24 timer postoperativt, den værste smerte ved bevægelsen registreres. Endpoint er AUC-VAS-mob (2-24 t) beregnet på basis af disse smertemål.
    Smertescore i hvile (VAS) til tiden 2, 6, 12, 18 og 24 timer postoperativt. Endpoint er AUC-VAS-hvile (2-24 t) beregnet på basis af disse smertemål.
    Graden af kvalme 0-24 timer, målt til tiden 2, 6, 12, 18 og 24 timer postoperativt.
    Antal af opkastninger 0-24 timer, registreret i perioderne 0-2, 2-6, 6-12, 12-18, 18-24 timer postoperativt.
    Forbrug af ondansetron i perioden 0-24 timer postoperativt.
    Graden af sedation 0-24 timer, målt til tiden 2, 6, 12, 18 og 24 timer postoperativt.
    Hallucinationer og mareridt 0-24 timer postoperativt.
    Kroniske smerter og fast forbrug af opioider vurderes ved et valideret spørgeskema 6- og 12 måneder postoperativt
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients undergoing lumbar spinal fusion surgery i generel anaesthesia.
    Daily use of opioids for a minimum of 6 weeks preoperatively (morphine, ketobemidon, oxycodon, fentanyl, tramadol and/or buprenorphine).
    Back pain for a minimum of 3 months preoperatively.
    Age &gt; 18 years and &lt; 85 years.
    ASA 1-3.
    BMI &gt; 18 and &lt; 40.
    Fertile women need to have a negative urine HCG pregnancy test.
    Patients who have given their written informed consent to participate in the study after having fully understood the content and limitations of the study
    Patienter indstillet til lumbal dese rygkirurgi i generel anæstesi
    Fast daglig behandling med opioider minimum 6 uger præoperativt (morfin, ketogan, oxycodon, fentanyl, tramadol og/eller buprenorfin)
    Rygsmerter i minimum 3 måneder præoperativt
    Alder &gt; 18 år og &lt; 85 år
    ASA 1-3.
    BMI &gt; 18 og &lt; 40
    For kvinder i den fertile alder gælder, at de skal have en negativ urin HCG graviditetstest.
    Patienter, som har givet deres skriftlige informerede samtykke til at deltage i undersøgelsen efter at have forstået protokollens indhold og begrænsninger fuldt ud.
    E.4Principal exclusion criteria
    Participation in another drug trial.
    Patients who do not understand or speak Danish.
    Allergy to the drugs used in the trial.
    Abuse of drugs - assessed by the investigator.
    Daily methadone use.
    Increased intraocular pressure - assessed via the patients chart.
    Uncontrolled hypertension - assessed via the patients chart.
    Previous and current psychotic episodes - assessed via the patients chart
    Deltagelse i andet lægemiddelforsøg
    Patienter, som ikke forstår eller taler dansk.
    Allergi over for de i undersøgelsen anvendte stoffer.
    Misbrug af rusmidler – efter investigators skøn.
    Fast metadon behandling
    Kendt forhøjet intraokulært tryk, kontrolleres via patientens journal.
    Ukontrolleret hypertension, kontrolleres via patientens journal.
    Tidligere og nuværende psykotiske episoder, kontrolleres via patientens journal
    E.5 End points
    E.5.1Primary end point(s)
    Total morphine consumption, other than the patients usual opioid use, 0-24 hours postoperatively, administered on as patient-controlled analgesia (PCA, bolus 2.5 mg, lockout 10 minutes)
    Det totale morfinforbrug, ud over patientens vanlige opioid, 0 - 24 timer postoperativt, administreret som patient-kontrolleret smertebehandling (PCA, bolus 2,5 mg, lockout 10 minutter)
    E.5.1.1Timepoint(s) of evaluation of this end point
    0 - 24 hours postoperatively
    0 - 24 timer postoperativt
    E.5.2Secondary end point(s)
    Pain score during active mobilisation, measured on a visual analogue scale (VAS), defined ad a standarised movement from recumbent position to sitting on the bedside at 2, 6, 12, 18 and 24 hours postoperatively, the worst pain from the movement is registered. Endpoint is AUC-VAS-mob (2-24 t) calculated from these measurements.
    • Pain score during rest (VAS), at 2, 6, 12, 18 and 24 hours postoperatively. Endpoint is AUC-VAS-mob (2-24 t) calculated from these measurements.
    • Degree of nausea 0-24 hours at time 2, 6, 12, 18 og 24 hours postoperatively.
    • Number of episodes vomiting 0-24 hours, registered in periods 0-2, 2-6, 6-12, 12-18, 18-24 hours postoperatively.
    • Use of ondansetron during the period 0-24 hours postoperatively .
    • Degree of sedation 0-24 hours, at time 2, 6, 12, 18 og 24 hours postoperatively.
    • Hallucinations and nightmares 0-24 hours postoperatively.
    • Chronic pain and daily use of opioids assessed by questionnaire 6- and 12 months postoperatively.
    Smertescore i forbindelse med aktiv mobilisation, målt på visuel analog skala (VAS), defineret ved standardiseret bevægelse fra liggende stilling til siddende på sengekanten til tiden 2, 6, 12, 18 og 24 timer postoperativt, den værste smerte ved bevægelsen registreres. Endpoint er AUC-VAS-mob (2-24 t) beregnet på basis af disse smertemål.
    • Smertescore i hvile (VAS) til tiden 2, 6, 12, 18 og 24 timer postoperativt. Endpoint er AUC-VAS-hvile (2-24 t) beregnet på basis af disse smertemål.
    • Graden af kvalme 0-24 timer, målt til tiden 2, 6, 12, 18 og 24 timer postoperativt.
    • Antal af opkastninger 0-24 timer, registreret i perioderne 0-2, 2-6, 6-12, 12-18, 18-24 timer postoperativt.
    • Forbrug af ondansetron i perioden 0-24 timer postoperativt.
    • Graden af sedation 0-24 timer, målt til tiden 2, 6, 12, 18 og 24 timer postoperativt.
    • Hallucinationer og mareridt 0-24 timer postoperativt.
    • Graden af kroniske smerter og fast forbrug af opioider vurderes ved hjælp af et valideret spørgeskema som sendes til patienterne 6- og 12 måneder postoperativt.
    E.5.2.1Timepoint(s) of evaluation of this end point
    0 - 24 hours postoperatively and 6- and 12 months postoperatively
    0 - 24 timer postoperativt og 6- and 12 måneder postoperativt
    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 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 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 Yes
    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 Yes
    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
    GCP unit, Bispebjerg Hospital
    GCP enhed, Bispiebjerg Hospital
    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 days21
    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: 160
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 160
    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 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 2014-03-10. 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 Yes
    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 state160
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 160
    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)
    Chronic pain and daily use of opioids assessed by a validated questionnaire 6- and 12 months postoperatively
    Graden af kroniske smerter og fast forbrug af opioider vurderes ved hjælp af et valideret spørgeskema som sendes til patienterne 6- og 12 måneder postoperativt
    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 Decision2014-04-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-04-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-10-02
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