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    Summary
    EudraCT Number:2012-004181-18
    Sponsor's Protocol Code Number:SM-RS-2012
    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:2012-11-23
    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 number2012-004181-18
    A.3Full title of the trial
    The effect of dexamethasone in combination with paracetamol and ibuprofen as adjuvant, postoperative pain after herniated disk surgery
    Effekten af dexamethason i kombination med parace-tamol og ibuprofen som adjuverende, postoperativ smertebehandling efter diskusprolapskirurgi
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effect of dexamethasone in combination with paracetamol and ibuprofen for analgesia after surgery for herniated
    Virkningen af dexamethason sammen med paracetamol og ibuprofen som smertebehandling efter operation for diskusprolaps
    A.4.1Sponsor's protocol code numberSM-RS-2012
    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 SponsorRigshospitalet; Department of Anaesthesia
    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 supportRigshospitalet; Department of Anaesthesia
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRigshospitalet, Dept. of Anaesthesia 4231
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street AddressBlegdamvej 9
    B.5.3.2Town/ cityCopenhagen
    B.5.3.3Post code2100
    B.5.3.4CountryDenmark
    B.5.4Telephone number+4535459502
    B.5.5Fax number+4535452950
    B.5.6E-mailrikkesoennichsen@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 Dexagalen
    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 nameDexamethason
    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.3.9.3Other descriptive nameDEXAMETHASONE
    D.3.9.4EV Substance CodeSUB07017MIG
    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
    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
    Patients set to lumbar prolapse surgery in general anesthesia
    Patienter indstillet til lumbal prolaps kirurgi i generel anæstesi
    E.1.1.1Medical condition in easily understood language
    The patient set to undergo surgery for a slipped disc in the lower back
    Patienten indstillet til at blive opereret for en diskosprolaps i lænderyggen
    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 14.1
    E.1.2Level LLT
    E.1.2Classification code 10054711
    E.1.2Term Postoperative pain
    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
    To investigate the effect of dexamethasone in combination with paracetamol and ibuprofen as adjuvant, postoperative pain after herniated disk surgery
    At undersøge effekten af dexamethason i kombination med paracetamol og ibuprofen som adjuverende, postoperativ smertebehandling efter diskusprolapskirurgi.
    E.2.2Secondary objectives of the trial
    Not Applicable
    Not Applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age> 18 years and <85 years
    • Patients set to lumbar prolapse surgery in general anesthesia
    • Patients who have given written informed consent to participate in the study after having understood the contents of the protocol and limitations in full.
    • ASA 1-3.
    • BMI> 18 and <40
    •Alder > 18 år og < 85 år
    •Patienter indstillet til lumbal prolaps kirurgi i generel anæstesi
    •Patienter, som har givet deres skriftlige informerede samtykke til at del-tage i undersøgelsen efter at have forstået protokollens indhold og be-grænsninger fuldt ud.
    •ASA 1-3.
    •BMI > 18 og < 40
    E.4Principal exclusion criteria
    •Patienter som ikke kan samarbejde til undersøgelsen.
    •Patienter som ikke forstår eller taler dansk.
    •Allergi over for de i undersøgelsen anvendte stoffer.
    •Alkohol- og/eller medicinmisbrug – efter investigators skøn.
    •Patienter som er tidligere rygopererede.
    •Dagligt forbrug af stærke opioider (morfin, ketogan, oxynorm, metadon,
    fentanyl).
    Fast per oral steroid behandling.
    Patients who can not cooperate with the investigation.
    •Patients who do not understand or speak Danish.
    •Allergy to those used in the study drugs.
    •Alcohol and / or drug abuse - the investigator's opinion.
    •Patients who have previously rygopererede.
    •Daily consumption of strong opioids (morphine, Ketogen, Oxynorm, methadone,
    fentanyl).
    Real per oral steroid treatment.
    E.5 End points
    E.5.1Primary end point(s)
    Pain Score of active mobilization (VAS) defined by standardized moving from a lying position to sitting on the edge of the bed on time 2, 4, 8, 12 and 24 hours, calculated as the area under the curve (AUC) from 2-24 hours postoperatively.
    Smertescore i forbindelse med aktiv mobilisation (VAS) defineret ved standardiseret bevægelse fra liggende stilling til siddende på sengekanten til tiden 2, 4, 8, 12 og 24 timer, beregnet som arealet under kurven (AUC) fra 2-24 timer postoperativt.
    E.5.1.1Timepoint(s) of evaluation of this end point
    pain score at the time 2, 8, 12 24 and 48 hours after administration of study drug
    smertescore til tiden 2, 8 12 24 og 48 timer efter indgift af studydrug
    E.5.2Secondary end point(s)
    The total need for morphine from 0 to 24 hours post-operatively, administered as patient-controlled pain (bolus 2.5 mg, lockout 10 minutes) and escape morphine.
    • in the resting pain score (VAS) at time 2, 4, 8, 12 and 24 hours, calculated as the area under the curve (AUC) from 2 to 24 hours postoperatively.
    • Pain score at rest and during active mobilization on time 48 hours postoperatively.
    • the degree of nausea at time 2, 4, 8, 12, 24, and 48 hours postoperatively
    • Number of vomiting during the periods 0-2, 2-4, 4-8. 8-12, 12-24, 24-48 hours post-operatively.
    • Consumption of Zofran between 0-24 and 24-48 hours post-operatively.
    • the degree of sedation at time 2, 4, 8, 12, 24, and 48 hours postoperatively.
    • sleep quality assessed 24 hours post-operatively on a visual scale of 0 to 100 mm, where 0 = best possible sleep, and 100 = worst sleep.
    •Det totale behov for morfin fra 0 til 24 timer postoperativt, administreret som patient-kontrolleret smertebehandling (bolus 2,5 mg, lockout 10 minutter) og escape morfin.
    •Smertescore i hvile (VAS) til tiden 2, 4, 8, 12 og 24 timer, beregnet som arealet under kurven (AUC) fra 2-24 timer postoperativt.
    •Smertescore i hvile og under aktiv mobilisation til tiden 48 timer postoperativt.
    •Graden af kvalme til tiden 2, 4, 8, 12, 24 og 48 timer postoperativt
    •Antal af opkastninger i perioderne 0-2, 2-4, 4-8. 8-12, 12-24, 24-48 timer postoperativt.
    •Forbrug af Zofran i perioden 0-24 og 24-48 timer postoperativt.
    •Graden af sedation til tiden 2, 4, 8, 12, 24 og 48 timer postoperativt.
    •Søvnkvalitet vurderet 24 timer postoperativt på en visuel skala fra 0-100 mm, hvor 0=bedst tænkelige søvn, og 100=værst tænkelige søvn.
    E.5.2.1Timepoint(s) of evaluation of this end point
    2,4,8,12,24 and 48 hours after administration og studydrug
    2,4,8,12,24 og 48 timer efter indgift af studydrug
    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 No
    E.6.5Efficacy No
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    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
    It is planned to include 100 patients - study drug will be given just before anesthesia start - LPLV is 48 hours after the last dose of study drug
    Det planlægges at inkludere 100 patienter - studydrug vil blive givet lige før anæstesistart - LPLV er 48 timer efter sidste indgift af studydrug
    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 months10
    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: 60
    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 state100
    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)
    The department's standard pain treatment after lumbar prolapse surgery
    Afdelingens standard smertebehandling efter lumbal prolaps kirurgi
    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 Decision2012-11-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-11-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-08-29
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