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    Summary
    EudraCT Number:2016-002251-13
    Sponsor's Protocol Code Number:24052016
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2016-10-20
    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 ConcernedFinland - Fimea
    A.2EudraCT number2016-002251-13
    A.3Full title of the trial
    The effect of intravenous single-dose dexamethasone on pain after total knee replacement surgery.
    Laskimonsisäisen deksametasonin kerta-annoksen vaikutus polven tekonivelleikkauksen jälkeiseen kipuun.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effect of intravenous single-dose dexamethasone on pain after total knee replacement surgery.
    Laskimonsisäisen deksametasonin kerta-annoksen vaikutus polven tekonivelleikkauksen jälkeiseen kipuun.
    A.3.2Name or abbreviated title of the trial where available
    The effect of intravenous single-dose dexamethasone on pain after total knee replacement surgery.
    Laskimonsisäisen deksametasonin kerta-annoksen vaikutus polven tekonivelleikkauksen jälkeiseen kipuu
    A.4.1Sponsor's protocol code number24052016
    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 SponsorOulu university hospital
    B.1.3.4CountryFinland
    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 supportOulu university hospital
    B.4.2CountryFinland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOulu university hospital
    B.5.2Functional name of contact pointOulu university hospital
    B.5.3 Address:
    B.5.3.1Street AddressOpTA Anestesia PL 21
    B.5.3.2Town/ cityOYS
    B.5.3.3Post code90029
    B.5.3.4CountryFinland
    B.5.6E-mailmatti.kyllonen@ppshp.fi
    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 Oradexon
    D.2.1.1.2Name of the Marketing Authorisation holderAspen Pharma Trading Limited 3016 Lake Drive Citywest Business Campus Dublin 24 Ireland
    D.2.1.2Country which granted the Marketing AuthorisationFinland
    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 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.3.9.3Other descriptive nameDEXAMETHASONE SODIUM PHOSPHATE
    D.3.9.4EV Substance CodeSUB01615MIG
    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 placeboInjection
    D.8.4Route of administration of the placeboIntravenous bolus use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with arthrosis of knee joint needing operative treatment i.e. arthroplasty of knee.
    Potilaat, joilla polvinivelen artroosi ja joille tehdään tämän vuoksi polven tekonivelleikkaus.
    E.1.1.1Medical condition in easily understood language
    Patients with knee joint arthritis needing knee joint replacement surgery.
    Potilaat, joille tehdään nivelkuluman vuoksi polven tekonivelleikkaus.
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    MedDRA Classification
    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 of the trial is to find out if single-dose intravenous dexamethasone alleviates postoperative dynamic (during walking) pain during the first two days after total knee replacement surgery.
    Tutkimuksen tarkoitus on selvittää vähentääkö kerta-annoksena annettu laskimonsisäinen deksametasoni leikkauksen jälkeistä dynaamista (kävely) kipua kahden ensimmäisen leikkauksenjälkeisen vuorokauden aikana polven tekonivelleikkauksen jälkeen.
    E.2.2Secondary objectives of the trial
    Effects on postoperative pain at rest, consumption of oxycodone, nausea/vomiting, "wellbeing" and time to hospital discharge are studied. The extent of postoperative inflammatory reaction is observed. Possible side-effects of dexamethasone are studied: blood glucose measurement, quality of sleep, wound healing and wound infection.
    Seurataan vaikutusta leikkauksenjälkeiseen oksikodonin kulutukseen, lepokipuun, pahoinvointiin, yleiseen ”hyvinvointiin” ja kotiutuskriteerien täyttymisajankohtaan. Leikkauksenjälkeisen tulehdusreaktion voimakkuutta seurataan.
    Deksametasonin mahdollisia haittavaikutuksia kartoitetaan seuraamalla potilaiden verensokeriarvoja, unen laatua, haavan paranemista ja haavainfektioiden ilmaantumista.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - patients having primary knee arthroplasty
    - age 18 years or older
    - ASA (American society of anesthesiologists) class 1-3
    - polven ensimmaiseen tekonivelleikkaukseen tulevat potilaat
    - täysi-ikäisyys
    - ASA (American society of anesthesiologists) luokka 1-3
    E.4Principal exclusion criteria
    -coronary artery disease with severe symptoms, heart- or kidney failure
    - insulin dependent diabetes mellitus or poorly controlled diabetes
    - peptic ulcer
    - allergy or contraindication to any of medications used in the study
    - enteral/parenteral use of glucocorticoids during the last three months before the operation
    - opioids usage before the operation at home (other than codeine, tramadol)
    - neuropathy of lower limbs
    - lack of co-operation
    - inability to use the PCA-device
    - vaikeaoireinen sepelvaltimotauti, sydämen tai munuaisten vajaatoiminta
    - insuliinihoitoinen tai epätasapainossa oleva diabetes
    - vatsa/pohjukaissuolihaavauma
    - allergia tai vasta-aihe tutkimuksessa käytettäville lääkkeille
    - käytössä kortikosteroidivalmisteita viimeisen 3 kk:n aikana
    - opioidikipulääkitys kotikäytössä (poislukien kodeiini ja tramadoli)
    - neuropatia/tuntohäiriö alaraajoissa
    - ko-operaation puute
    - kyvyttömyys käyttää PCA-laitetta
    E.5 End points
    E.5.1Primary end point(s)
    Dynamic pain during walking/standing 24 h postoperatively. Measured on numeric rating scale (NRS) 0-10, where 0 is no pain and 10 is the worst pain imaginable.
    Dynaaminen kipu kävellessä/seisoessa 24 h leikkauksen jälkeen. Kipu mitataan numeerisella asteikolla (NRS) 0-10, jossa 0 = ei kipua ja 10 = pahin kipu.
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 h postoperatively
    24 h leikkauksen jälkeen
    E.5.2Secondary end point(s)
    - dynamic pain (NRS 0-10) on the day of operation, 48 h postoperatively, seventh day postoperatively

    -pain at rest (NRS 0-10) day of operation (recovery room, evening), first postoperative day (24 h postoperatively, evening), second postoperative day (48 h postoperatively), seventh day postoperatively

    - consumption of oxycodone (mg) 0-24 h, 0-48 h

    -nausea (NRS 0-10) day of operation, first postoperative day, second postoperative day

    - vomiting +/- day of operation, first postoperative day, second postoperative day

    -general wellbeing (NRS 0-10) first postoperative day, second postoperative day

    - quality of sleep (NRS 0-10) first postoperative night, second postoperative night

    - time to achieving discharge criteria (hrs after operation)

    - blood glucose (intraoperatively, recovery room, first and second postoperative day, additional measurements as necessary for treatment)

    - C-reactive proteiini (CRP) first and second postoperative morning

    - urinary retention +/-
    - Dynaaminen kipu (NRS 0-10) leikkauspäivän iltana, 48 h leikkauksen jälkeen, seitsemäs päivä leikkauksen jälkeen

    - Kipu levossa (NRS 0-10): heräämö, leikkauspäivänä ennen ylösnousua, 24 h postop, 1. leikkauksen jälkeinen ilta, 48 h leikkauksen jälkeen, seitsemäs päivä leikkauksen jälkeen

    - Oksikodonin kulutus (mg) 0-24 h, 0-48 h

    - Pahoinvointi (NRS 0-10) leikkauspäivä, 1. leikkauksen jälkeinen päivä, 2. leikkauksen jälkeinen päivä

    - Oksentelu
 +/-, leikkauspäivä, 1-2 leikkauksen jälkeinen päivä

    - Yleinen hyvinvointi (NRS 0-10) 1. leikkauksen jälkeinen päivä, 2. leikkauksen jälkeinen päivä

    - Yöunen laatu (NRS 0-10) 1. leikkauksen jälkeinen yö, 2. leikkauksen jälkeinen yö

    - Kotiutuskriteerien saavuttaminen (tuntia leikkauksen jälkeen)

    - Verensokeri (b-gluk salissa, heräämössä, 1. leikkauksen jälkeinen aamu, 2. leikkauksen jälkeinen aamu , jos > 10 mmol/l: hoito ja mittaus tiheämmin (2-6 h välein) tarv

    - C-reaktiivinen proteiini (CRP) 1. leikkauksen jälkeinen aamu, 2. leikkauksen jälkeinen aamu

    - Virtsaretentio +/-
    E.5.2.1Timepoint(s) of evaluation of this end point
    see E.5.2
    Katso E.5.2
    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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    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 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 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
    Checking the medical records of the last subject three months after the operation.
    Viimeisen tutkittavan potilaskertomuksen tarkistaminen kolme kuukautta leikkaustoimenpiteen jälkeen.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    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: 26
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 70
    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 state96
    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
    Ei ole
    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 Decision2016-11-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-10-17
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2018-04-10
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