Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43876   clinical trials with a EudraCT protocol, of which   7294   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2020-005034-15
    Sponsor's Protocol Code Number:DXMT
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-02-24
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2020-005034-15
    A.3Full title of the trial
    EFFECT OF DEXAMETASONE ON LOWER LIMB EDEMA IN PATIENTS UNDERTAKEN FOR TOTAL HIP ARTHROPLASTY
    EFECTO DE LA DEXAMETASONA EN EL EDEMA DE LA EXTREMIDAD INFERIOR EN PACIENTES INTERVENIDOS DE ARTROPLASTIA TOTAL DE CADERA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    EFFECT OF TREATMENT WITH DEXAMETASONE ON INFLAMMATION OF THE LOWER LIMB IN PATIENTS UNDERTAKEN FOR TOTAL HIP ARTHROPLASTY
    EFECTO DEL TRATAMIENTO CON DEXAMETASONA EN LA INFLAMACION DE LA EXTREMIDAD INFERIOR EN PACIENTES INTERVENIDOS DE ARTROPLASTIA TOTAL DE CADERA
    A.3.2Name or abbreviated title of the trial where available
    DXMT
    DXMT
    A.4.1Sponsor's protocol code numberDXMT
    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 SponsorHOSPITAL DR JOSEP TRUETA
    B.1.3.4CountrySpain
    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 supportHOSPITAL DR JOSEP TRUETA
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHOSPITAL DR JOSEP TRUETA
    B.5.2Functional name of contact pointCRISTINA MARTINEZ
    B.5.3 Address:
    B.5.3.1Street AddressAVDA FRANÇA S/N
    B.5.3.2Town/ cityGIRONA
    B.5.3.3Post code17007
    B.5.3.4CountrySpain
    B.5.4Telephone number00349729402002343
    B.5.5Fax number0034972485422
    B.5.6E-mailCMARTINEZ@IDIBGI.ORG
    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 DEXAMETASONE
    D.2.1.1.2Name of the Marketing Authorisation holderFORTECORTIN
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameDEXAMETASONE
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    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.3.8INN - Proposed INNDEXAMFETAMINE PHOSPHATE
    D.3.9.1CAS number 7528-00-9
    D.3.9.2Current sponsor codeDEXAMETASONE
    D.3.9.4EV Substance CodeSUB01621MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 sodium chloride
    D.2.1.1.2Name of the Marketing Authorisation holderFisiological serum
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 Concentrate for 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.3.8INN - Proposed INNPHISIOLOGICAL SERUM
    D.3.9.3Other descriptive nameSODIUM CHLORIDE SOLUTION 0.9%
    D.3.9.4EV Substance CodeSUB20079
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    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
    POST -OPERATIVE LOWER LIMB EDEMA
    EDEMA DE LA EXTREMIDAD INFERIOR POST OPERATORIA
    E.1.1.1Medical condition in easily understood language
    INFLAMMATION OF THE LOWER LIMB (LEG) POST-OPERATIVE
    INFLAMACION DE LA EXTREMIDAD INFERIOR (PIERNA) POST OPERATORIO
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10014220
    E.1.2Term Edema extremities
    E.1.2System Organ Class 100000004867
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluate the anti-inflammatory role of dexamethasone in reducing postoperative edema in patients undergoing total hip arthroplasty.
    Evaluar el papel antiinflamatorio de la dexametasona en la disminución del edema postoperatorio en pacientes intervenidos de artroplastia total de cadera.
    E.2.2Secondary objectives of the trial
    - Evaluate the reduction of postoperative pain in patients who have been administered dexamethasone preoperatively.

    - Study the influence of the different approaches to Total Hip Arthroplasty on the appearance of postoperative edema in the operated limb.

    - Describe the influence of intravenous peroperative Dexamethasone in improving rapid recovery programs in total hip arthroplasty
    - Evaluar la disminución del dolor postoperatorio en pacientes a los que se les ha administrado dexametasona preoperatoriamente.

    - Estudiar la influencia de las distintas vías de abordaje de la Artroplastia Total de Cadera en la aparición de edema postoperatorio en la extremidad intervenida.

    - Describir la influencia de la Dexametasona peroperatoria endovenosa en la mejora de los programas de recuperación rápida en artroplastia total de cadera
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    a. Men and women aged 30-80 years
    b. Patients that undergo primary total hip replacement.
    c. Diagnosis of primary hip osteoarthritis.
    d. They accept and sign the informed consent
    a. Hombres y mujeres de 30-80 años
    b. Pacientes que vayan a someterse a artroplastia total de cadera primaria.
    c. Diagnóstico de artrosis primaria cadera.
    d. Aceptan y firman el consentimiento informado
    E.4Principal exclusion criteria
    a. Patient undergoing corticosteroid treatment during the last 6 months before surgery.
    b. Patients with a diagnosis of secondary osteoarthritis of the hip.
    c. Patients with a diagnosis of hip fracture
    d. Allergic patients to Dexamethasone.
    e. Patients who meet the criteria for malnutrition.
    F. Patient with a diagnosis of Diabetes Mellitus (DM1 and DM2)
    g. Patients with Congestive Heart Failure (CHF)
    h. Patients with Chronic Renal Insufficiency (eGFR˂60).
    i. Patients with peripheral venous insufficiency
    j. Patients diagnosed with previous lymphedema.
    k. Patients with alterations of the cortico-adrenal axis
    l. Any condition that, in the clinical judgment of the researchers, may interfere with the object of the research
    a. Paciente en tratamiento con corticoides durante los últimos 6 meses antes de la cirugía.
    b. Pacientes con diagnóstico de artrosis secundaria de cadera.
    c. Pacientes con diagnóstico de fractura de cadera
    d. Pacientes alérgicos a Dexametasona.
    e. Pacientes que cumplan con criterios de malnutrición.
    f. Paciente con diagnostico de Diabetes Mellitus (DM1 y DM2)
    g. Pacientes con Insuficiencia Cardiaca Congestiva (ICC)
    h. Pacientes afectos de Insuficiencia Renal Crónica (IRC, FG˂60).
    i. Pacientes con insuficiencia venosa periférica (IVP).
    j. Pacientes diagnosticados de linfedema previo.
    k. Pacientes con alteraciones del eje cortico-adrenal
    l. Cualquier condición que a juicio clínico de los investigadores pueda interferir en el objeto de la investigación
    E.5 End points
    E.5.1Primary end point(s)
    • Thigh circumference
    • Leg Perimeter
    • PCR value
    • IL-6 value
    • Perímetro Muslo
    • Perímetro Pierna
    • Valor PCR
    • Valor IL-6
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 week after surgical intervention
    1 semana tras intervencion quirúrgica
    E.5.2Secondary end point(s)
    sex
    Age
    Body mass index
    Medical history
    Type of approach
    Physiotherapy start day
    Time of admission
    Postoperative visual analog scale (VAS)
    • Harris Functional Scale (HHS)
    Edad
    Sexo
    Índice de masa corporal
    Antecedentes patologicos
    Tipo de abordaje
    Día inicio fisioterapia
    Tiempo de ingreso
    Escala visual analógica (EVA) postoperatorio
    Escala funcional de Harris (HHS)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Discharge date
    Alta hospitalaria
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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 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 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 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
    Ultima visita del último paciente incluido en el estudio
    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 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: 47
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 state62
    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)
    TREATMENT ADMINISTERED DURING SURGICAL INTERVENTION. THERE IS NO POST TREATMENT PLAN AFTER PATIENT FINISHES THE STUDY
    TRATAMIENTO ADMINISTRADO DURANTE INTERVENCION QUIRURGICA. NO HAY PLAN DE TRATAMIENTO TRAS FINALIZACION ESTUDIO
    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 Decision2022-10-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-10-03
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sat May 11 18:57:24 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA