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    Summary
    EudraCT Number:2018-002634-20
    Sponsor's Protocol Code Number:NBF_HK_01_2018
    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:2018-08-27
    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 number2018-002634-20
    A.3Full title of the trial
    Highdose steroid for total knee arthroplasty - A randomized doubleblindet controlled trial.
    Højdosis steroid til Total KnæAlloplastik - Et randomiseret, dobbeltblindet kontrolleret forsøg.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Highdose steroid for knee replacement surgery - A lottery-based doubleblindet controlled study.
    Højdosis steroid til udskiftning af knæ - lodtrækningsforsøg med dobbeltblinding.
    A.4.1Sponsor's protocol code numberNBF_HK_01_2018
    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 SponsorAnaesthesia Department, Hvidovre Hospital, Capital Region of Denmark
    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 supportClinic of Pathophysiology, University of Copenhagen
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAnaesthesia Department, Hvidovre Hospital, Capital Region of Denmark
    B.5.2Functional name of contact pointResearch group, anaesthesia Dept.
    B.5.3 Address:
    B.5.3.1Street AddressKettegård Alle 30
    B.5.3.2Town/ cityHvidovre
    B.5.3.3Post code2650
    B.5.3.4CountryDenmark
    B.5.4Telephone number+4538623862
    B.5.6E-mailNicolai.Bang.Foss@regionH.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 Dexa-ratiopharm ®
    D.2.1.1.2Name of the Marketing Authorisation holderRatiopharm GmbH
    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.3.4Pharmaceutical 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 INNDEXAMETHASONE
    D.3.9.1CAS number 312-93-6
    D.3.9.3Other descriptive nameDEXAMETHASONE PHOSPHATE
    D.3.9.4EV Substance CodeSUB01612MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    Perioperative management of total knee-arthroplasty because of knee-osteoarthritis
    Perioperativ optimering af total knæalloplastik på baggrund af slidgigt i knæ.
    E.1.1.1Medical condition in easily understood language
    Management of total knee-replacement surgery because of knee-osteoarthritis
    Perioperativ optimering af udskiftning af knæ på baggrund af slidgigt i knæ.
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    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 20.1
    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 amount of patients with VAS >30 in a 5-meter walk test, 24 hours postoperatively efter total kneearthroplasty.
    At undersøge andelen af patienter med VAS >30 ved en 5 meter gangtest 24 timer postoperativt efter Total KnæAlloplastik.
    E.2.2Secondary objectives of the trial
    To investigate the reasons for resumed hospitalization in the days after total knee-arthroplasty.
    At undersøge årsager til fortsat indlæggelse i dagene efter total knæalloplastik
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    The sub-study has been suspended in the 3.0 version, approved 4. december 2019 with terms by the Danish Medicines Agency. ¨

    Former substudy: Glucose-homeostasis and Quadriceps-muscle loss during TKA and the effect of Dexamethasone.
    Substudiet er blevet suspenderet i 3.0 versionen, godkendt med vilkår 4. december af DKMA.

    Tidligere substudie: Glukose-homeostase og Quadriceps-muskel tab under TKA og effekten af Dexamethason.
    E.3Principal inclusion criteria
    - Age between 40 and 90.
    - Booked for unilateral knee-arthroplasty.
    - Is able to take part in the investigation(selfreporting of pain and nausea/vomitting)
    - Understands Danish or English, or has a translator available.
    - Signatured written consent.
    - Alder imellem 40 og 90 år.
    - Bookes til primær TKA unilateralt,
    - Kan medvirke til undersøgelsen (selvrapportere smerter/kvalme).
    - Forstår dansk/engelsk, eller har tolk under indlæggelse.
    - Underskrevet skriftligt samtykke.
    E.4Principal exclusion criteria
    - Insulin-dependent diabetes melitus.
    - Ongoing treatment with systemic glucocorticoids or immunesuppressing treatment(apart from inhaled glucocorticoids).
    - Pregnancy/Breastfeeding
    - Allergies for the investigational drug.
    - Daily use of opiods.
    - A pain catastrophizing scale(PCS) score of >20.
    - A history of schizophrenia or bipolar diseases, or patients with permanent use of antipsychotic medication.
    - Insulinbehandlet DM
    - Aktuel behandling m. systemisk glukokortikoid eller immunsupressiv behandling (fraset inhalationssteroid).
    - Graviditet/amning.*
    - Allergi overfor undersøgelsesmedicin.
    - Vanligt forbrug af opioid.
    - Personer som scorer >20 på Pain Catastrophizing Scale(PCS).
    - Personer som lider af skizofreni eller bipolær sygdom, samt personer som tager fast antipsykotika.
    E.5 End points
    E.5.1Primary end point(s)
    The amount of patients with VAS>30 in a 5 meter walk test 24 hours postoperatively after total knee-arthroplasty.
    Andelen af patienter med VAS >30 ved en 5 meter gangtest 24 timer postoperativt efter total knæalloplastik.
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 hours postoperatively
    24 timer postoperativt
    E.5.2Secondary end point(s)
    - Pain upon rest and in a 5-meter walking test 4, 24 and 48 hours postoperatively, and filling out a 7 day pain-diary.
    - Acummulated painscore 0-48 hours postoperatively in rest and walking.
    - Duration of stay in PACU.
    - Length of stay in hospital.
    - "Why still in hospital"-registration at 9 hours postoperatively and 2 times daily the next 3 days.
    - Assesment of Opioid-related sideeffects (OR-SDS).
    - PONV after kneearthroplasty.
    - The need for, and amount of rescue analgetics during the perioperative, postoperative and reconvalescense phase until day 7.
    - The need for, and amount of rescue antiemetics during the perioperative, postoperative and reconvalescense phase until day 7.
    - The influence on the inflammatory response expressed by C-reactive protein(CRP), analysed preoperatively and 24 og 48 hours after surgery.
    - Quality of sleep, VAS.
    - Morbidity and mortality(30 and 90 days).
    - Smerter ved hvile og ved 5-meter gangtest til tiden 4 timer postoperativt, samt efter 24 og 48 timer samt 1 uges smertedagbog.
    - Kummuleret smertescore 0-48 timer v. hvile og gang.
    - Indlæggelsesvarighed på PACU
    - Indlæggelsesvarighed total (Length of stay, LOS).
    - Why still in hospital? Til tiden 9 timer + 2 x dagligt efterfølgende 3 dage (09.00 og 14.00)
    - Vurdering af Opioid-relaterede bivirkninger(OR-SDS)
    - Post-operative Quality of Recovery Scale(PQRS)
    - PONV efter TKA.
    - Analgetika behov udover standard under operation, i opvågningsfase, samt på sengeafdeling dag 0-5 og i hjemmet indtil dag 7.
    - Antiemetika behov udover standard medicinering under hele forløb.
    - Påvirkning af det inflammatoriske respons udtrykt ved C-reaktivt protein(CRP), målt præoperativt og 24 og 48 timer postoperativt.
    - Undersøgelse af søvnkvalitet.
    - Morbiditet og mortalitet (30 og 90 dage).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Individual
    Individuelt.
    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 No
    E.6.4Safety No
    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 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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Kontrolleret imod sig selv, lavere dosis(normal dosis) i kontrolgruppe.
    Controlled to itself, lower dose(normal dose) in control-group.
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    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
    LVLS
    LVLS
    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 months0
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 120
    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 No
    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 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 state160
    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
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-10-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-10-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-02-01
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