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    Summary
    EudraCT Number:2015-001214-10
    Sponsor's Protocol Code Number:AAUH-01-2015
    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:2015-04-16
    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 number2015-001214-10
    A.3Full title of the trial
    Analgetic effect of perioperative klorzoxazon at total hip or knee arthroplasty
    Analgetisk effekt af perioperative klorzoxazon ved total hofte- og knæalloplastik
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pain relief with klorzoxazon after incertion of a new hip or knee joint
    Smertelindring med klorzoxazon efter indsættelse af nyt hofte eller knæled.
    A.4.1Sponsor's protocol code numberAAUH-01-2015
    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 SponsorAalborg universitets 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 supportOrtopædkirurgisk forskningsenhed
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOrtopædkirurgisk forskningsenhed
    B.5.2Functional name of contact pointMichael Ulrich
    B.5.3 Address:
    B.5.3.1Street AddressSdr. Skovvej 15
    B.5.3.2Town/ cityAalborg
    B.5.3.3Post code9000
    B.5.3.4CountryDenmark
    B.5.6E-mailmichael.ulrich@rn.dk
    B.Sponsor: 2
    B.1.1Name of SponsorOrtopædkirurgisk forskningsenhed, Aalborg universitetshospital
    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 supportOrtopædkirurgisk forskningsenhed, Aalborg universitetshospital
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOrtopædkirurgisk forskningsenhed, Aalborg universitetshospital
    B.5.2Functional name of contact pointMichael Ulrich
    B.5.3 Address:
    B.5.3.1Street AddressHobrovej 18
    B.5.3.2Town/ cityAalborg
    B.5.3.3Post code9000
    B.5.3.4CountryDenmark
    B.5.4Telephone number4551882306
    B.5.6E-mailmichael.ulrich@rn.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 Klorzoxazon
    D.2.1.1.2Name of the Marketing Authorisation holderTakeda Pharma A/S, Dybendal Alle 10, 2630 Taastrup, Denmark
    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.3.4Pharmaceutical form 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 INNCHLORZOXAZONE
    D.3.9.1CAS number 95-25-0
    D.3.9.4EV Substance CodeSUB06215MIG
    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 placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Perioperative pain after incertion of hip or knee arthroplasty
    Perioperative smerter efter indsættelse af hofte- eller knæalloplastik
    E.1.1.1Medical condition in easily understood language
    Pain after incertion of af new hip or knee joint
    Smerter efter indsættelse af nyt hofte eller knæled
    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 18.0
    E.1.2Level PT
    E.1.2Classification code 10023469
    E.1.2Term Knee arthroplasty
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10020096
    E.1.2Term Hip arthroplasty
    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
    Investigate the effect of perioperative treatment with klorzoxazon compared to placebo. Out of need of suplementary analgentics and expierence of pain after incertion of hip or knee arthroplasty
    At belyse effekten af perioperativ behandling med oral klorzoxazon sammenlignet med placebo, ud fra behov for supplerende analgetika, oplevelse af smerteintensitet efter indsættelse af hofte eller knlprotese.
    E.2.2Secondary objectives of the trial
    To see how soon the patient can be mobilised after incertion of hip or knee arthroplasty
    At vurdere hvor hurtigt man mobiliseres efter indsættelse af hofte eller knæprotese
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Indication for primary, cnilateral hip or knee arthroplasty
    Age > 18
    Sex: male and female
    Patients with normal mental function so they are able to participate in the project.
    Patiens who has signed the information papers to participate
    • Patienter indstillet til primær, elektiv, unilateral THA eller TKA.
    • Alder > 18 år og myndig.
    • Køn: både mænd og kvinder.
    • Patienter med normal kognitiv og sproglig funktion (dvs patienten evner selvstændigt at
    forstå undersøgelsens information og medvirke adækvat til gennemførsel).
    • Patienter, som har givet deres skriftlige informerede samtykke til at deltage i
    undersøgelsen efter at have forstået denne.
    E.4Principal exclusion criteria
    Consumption af gabapentinoider, gluccocorticoider, opioider, anxiolytika, antiepileptika or antidrepressives within the last 4 weeks.
    Abuse of alkohol
    Need of pain treatment apart from he standard
    Malign condition
    Pregnancy og breastfeeding
    BMI > 40
    Disease affecting the cental nerveus system
    Allergy towards the medicine to be tested
    Perioperative complications
    Lack of ability to walk 5 meters
    Liver disease
    • Indtagelse af gabapentinoider, glucocorticoider, opioider, anxiolytika, antiepileptika eller
    antidepresiva indenfor de sidste 4 uger.
    • Alkoholmisbrug (mænd > 21 genstand per uge og kvinder > 14 genstande per uge).
    • Behov for anden smertebehandling end den i “standardpakken” angivne.
    • Aktuel malign lidelse.
    • Graviditet eller amning.
    • BMI > 40 kg/m2.
    • Sygdom påvirkende central eller perifer nervefunktion (og dermed smerteperception).
    • Allergi overfor forsøgmedicin.
    • Peroperative komplikationer (peroperativ fraktur, kar eller nerveskade).
    • Manglende evne til at kunne medvirke til 5 meters gang ved 2 døgn efter operation.
    • Leversygdom (f.eks. leverc)
    E.5 End points
    E.5.1Primary end point(s)
    Investigate treatment with tablet klorzoxazon 250mg 3 times a day from pre-operative medication and through the first 7 days after hip or knee arthroplasty. Whether it will relief pain and increase funktion level without further side effects or not.
    Undersøge adjuverende behandling med tablet klorzoxazon 250 mg givet 3 gange dagligt fra den præ-operative medicinering og igennem de første 7 postoperative døgn efter total hofte- eller knæalloplastik mindsker patienternes smerterespons og forbedrer deres funktionsniveau uden at medføre flere bivirkninger
    E.5.1.1Timepoint(s) of evaluation of this end point
    2. postoperative day pain will be rated after walking 5 meters using VAS
    2. postoperative døgn vurderes smerter ved 5 meters gang med VAS.
    E.5.2Secondary end point(s)
    Pain, funktion, medication, side effects and quality of life will be rated using different questionaires at certain times.
    Mobility:
    -Oxford Hip/Knee Score 2. 4. 7. 14. postoperative day and after 12 months.
    Pain:
    -Pain VAS (0-100) at 5 meters walk 4,6,24,28,32,48 hours postoperative. 2.til 7 day and day 14 morning and evening and after 12 month
    -Pain VAS(0-100) after rest> 20 min. 4,6,24,28,32,48 hours postoperativt. 2.til 7 day and day 14 morning and evening and after 12 month
    -Kumulativ painscore for painmodalities 4 to 48 hours, 2,. and 7. day and after 12 months.
    -Worst pain in hip or knee within the last 24 hours. Evening 2. til 7. day and day 14 and after 12 months.
    -Quantitative sensory testing 12 month
    -Supplementary analgetica 0-28 timer og 2. til 7. døgn
    -Average pain while resting day and night, average pain after walking efter 30 minutes.
    -Pain detect
    -Sense of pain VAS(0-100)
    -Pain catastrophizing scale
    Quality of life:
    -Pittsburg slepp quality index
    -Sleep VAS(0-100)
    -Hospitality and anxiety depression scale
    -European questionaire in 5 dimensions
    Side effects:
    -cumulative side effect score
    - medicine used for sleeping og nausea
    -Unwanted events
    Other:
    Operations date, sex, age, weight, hight, smoking, ASA-classifikation, analgetics before operation, time for operation and use of tourniquet, bloodloss, time in hospital and intensive care after oerration, perioperative complikationer.
    Amount of anaestetics and other medicine.


    Protokol VersionSmerter, funktion, medicinforbrug, bivirkninger og livskavlitet vil blive vurderet vha forskellige spørgeskemaer på udvalgte tidspunkter.
    Funktion:
    -Oxford Hip/Knee Score 2. 4. 7. og 14. postoperative døgn. samt efter 12 måneder.
    Smerte:
    -Smerte VAS (0-100) ved 5 meters gang 4,6,24,28,32,48 timer postoperativt. 2.til 7 døgn samt dag nr 14 morgen og aften og efter 12 måneder.
    -Smerte VAS(0-100) efter hvile > 20 min 4,6,24,28,32,48 timer postoperativt. 2.til 7 døgn samt dag nr 14 morgen og aften og efter 12 måneder.
    -Kumulativ smertescore for smertemodaliteterne 4 tl 48 timer, 2,. og 7. dag og efter 12 måneder.
    -Værste smerte i hofte eller knæ i de sidste 24 timer. 48. time aften 2. til 7. dag og dag nr 14.
    -Quantitative sensory testing 12 måneder.
    -Supplerende analgetika 0-28 timer og 2. til 7. døgn og efter 12 måneder.
    -Gennemsnitlig smerte i hvile om dagen/natten, gennemsnitlig smetre efter 30 min. gang.
    -Pain detect
    -Egen smertetærskel VAS(0-100)
    Livskvalitet:
    -Pain catastrophizing scale
    -Pittsburg slepp quality index
    -Nattesøvn VAS(0-100)
    -Hospitality and anxiety depression scale
    -European questionaire in 5 dimensions
    Bivirkninger:
    -Kumulativ bivirkningsscore
    -Forbrug af kvalme og sovemedicin.
    -Uønskede hændelser
    Andre værdier:
    Operations dato, køn, alder, vægt, højde, rygestatus, ASA-klassifikation, analgetika før operation, varighed af operation og evt blodtomhed, blodtab, Varighed af ophold på opvågning, indlæggelsestid, perioperative komplikationer.
    Mængde af anæstesimidler samt andet medicin.


    E.5.2.1Timepoint(s) of evaluation of this end point
    Data: medicaljournal, medicine accounts, patient diary and questionaires.
    At first examination or after 4,6,24,28,32,48 hours or after 2 to 7 days or after 14 days or 12 month depending on which questionaire is being used.
    Kildedata: lægejournal, medicinregnskab, patientdagbog og spørgeskemaer.
    Enten ved forundersøgelse eller efter 4,6,24,28,32 eller 48 timer og efter 2.til 7. dag efter 14 dage og 12 måneder alt efter hvilket parameter der undersøges.
    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) 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) 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
    After last examination of the last operated patient.
    Efter sidste kontrol af sidst opererede patient.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months4
    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.1.2.1Number of subjects for this age range: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 360
    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 state400
    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
    Ingen
    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 Decision2015-06-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-05-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-12-31
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