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    The EU Clinical Trials Register currently displays   37736   clinical trials with a EudraCT protocol, of which   6184   are clinical trials conducted with subjects less than 18 years old.
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    EudraCT Number:2018-001099-39
    Sponsor's Protocol Code Number:SM1-KAKG-2018
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-05-25
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedDenmark - DHMA
    A.2EudraCT number2018-001099-39
    A.3Full title of the trial
    Dexamethasone twice for pain treatment of total knee arthroplasty
    A randomized blinded placebo-controlled clinical trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    DEX-2-TKA - analgesic efficacy and safety of one or two doses of steroid (dexamethsone) after total knee arthroplasty
    A.4.1Sponsor's protocol code numberSM1-KAKG-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 SponsorNaestved Hospital
    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 supportDepartment of Anaesthesiology, Naestved Hospital
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNaestved Hospital
    B.5.2Functional name of contact pointDepartment of Anaesthesiology
    B.5.3 Address:
    B.5.3.1Street AddressRingstedgade 61
    B.5.3.2Town/ cityNaestved
    B.5.3.3Post code4700
    B.5.4Telephone number004556514002
    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. name Dexa-Ratiopharm
    D. of the Marketing Authorisation holderRatiopharm
    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 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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 placeboIntravascular use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Postoperative pain after total knee arthroplasty
    E.1.1.1Medical condition in easily understood language
    Postoperative pain after total knee arthroplasty
    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 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
    The objective of this trial is to investigate the analgesic efficacy and safety of one or two doses of dexamethasone after total knee arthroplasty
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    One-year follow-up with EQ-5D-5L, Oxford-Knee-Score and mortality including need for medical attention.
    Analysis of high and low pain responders.
    Troponin (TnI) levels 24 and 48 hours postoperatively (only at Naestved Hospital).
    Establishment of a bio-bank (blood-samples) for future studies (only at Naestved Hospital).
    E.3Principal inclusion criteria
    • Scheduled for unilateral, primary TKA, not Oxford (“uni-knee”).
    • Age ≥ 18
    • ASA 1-3
    • BMI ≥ 18.0 and ≤ 40.0
    • Negative urine HCG pregnancy test and use of anti-conception for women in the fertile age
    • Patients who gave their written informed consent to participating in the trial after having fully understood the contents of the protocol and restrictions
    E.4Principal exclusion criteria
    • Patients who cannot cooperate with the trial
    • Concomitant participation in another trial involving medication
    • Patients who cannot understand or speak Danish
    • Patients with allergy to medication used in the trial
    • Patients with daily use of high dose opioid (> oral morphine 30 mg/day or oxycodone 30 mg/day or tramadol 150 mg/day) or any use of other opioids including methadone and transdermal opioids.
    • Patients with at daily use of systemic glucocorticoids
    • Contraindications against ibuprofen or paracetamol, for example previous ulcer, known heart failure, known liver failure, or known renal failure (eGRF < 60 ml/kg/1,73m2), known thrombocytopenia (<100 bil/l); or against treatment with glucocorticoids.
    • Dysregulated diabetes (investigators judgement)
    • Patients suffering from alcohol and/or drug abuse – based on the investigator's judgement
    E.5 End points
    E.5.1Primary end point(s)
    Total need for i.v.-equivalent morphine for the first 48 hours postoperatively administered as patient controlled analgesia (PCA) morphine (0-24 hours), on demand oral morphine (24-48 hours) and supplemental morphine administered at the post-anaesthesia unit the first hour postoperatively after end of surgery (general anaesthesia) or end of spinal anaesthesia.
    E.5.1.1Timepoint(s) of evaluation of this end point
    i.v.-equivalent morphine for the first 48 hours postoperatively
    E.5.2Secondary end point(s)
    • Total need of i.v. morphine the first 24 hours postoperatively
    • Total need of oral morphine the following 24-48 hours
    • VAS-pain scores (visual analogue scale (VAS)):
    o at rest at 6, 24 and 48 hours postoperatively.
    o with active 45 degrees flexion of the knee (VAS) at 6, 24 and 48 hours postoperatively
    o highest and average score during the first 24 hours and 24-48 hours
    • Timed up and go (TUG) test at 24 and 48 hours including maximum pain during the TUG test.
    • Adverse events
    o Level of nausea at 6, 24 and 48 hours postoperatively
    o Level of sedation at 6, 24 and 48 hours postoperatively
    o Level of dizziness at 6, 24 and 48 hours postoperatively
    o Number of vomiting episodes (0-48 hours) measured in the periods 0-24 and 24-48 hours postoperatively
    o Number of patients with one or more patient-reported adverse events in the intervention period
    • Consumption of ondansetron (and DHB) in the period 0-24 and 24-48 hours postoperatively
    • Quality of sleep 0-24 and 24-48 hours postoperatively
    • Level of fatigue at 24 and 48 hours postoperatively
    • Questionnaire on pain, sleep, satisfaction and use of medication for postoperative days 3-7
    • Number of patients with one or more serious adverse events (SAE), including death, within 90 days after surgery defined as SAE (according to ICH-GCP-guidelines), except “prolongation of hospitalisation”
    • 90 days follow-up conducted by telephone with qualitative participant reported assessments using EQ5D5L + Oxford-Knee-Score and also need for medical attention and/or intervention including need for anti-biotics and/or re-operation
    E.5.2.1Timepoint(s) of evaluation of this end point
    See E.5.2 for timepoints in relation to the specific endpoint
    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 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. 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 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 concerned4
    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
    90 days after the last subject's surgery
    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: 186
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 300
    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 state486
    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 Decision2018-05-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-06-08
    P. End of Trial
    P.End of Trial StatusOngoing
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