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    Summary
    EudraCT Number:2019-000402-30
    Sponsor's Protocol Code Number:SO_SH_01_2019
    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:2019-03-14
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2019-000402-30
    A.3Full title of the trial
    The effect of perioperative dexamethasone administration on postoperative pain in patients undergoing periacetabular osteotomy:
    A randomised double-blind, placebo-controlled trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effect of adrenocortical hormone on operation related pain in patients after the operation for dysplasia of the hip.
    A.3.2Name or abbreviated title of the trial where available
    PAODEX
    A.4.1Sponsor's protocol code numberSO_SH_01_2019
    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 SponsorViktoria Lindberg-Larsen
    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 supportSouth Danish Tissue Centre
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDept. of anaesthesiology and intensive medicine, Odense University Hospital
    B.5.2Functional name of contact pointViktoria Lindberg-Larsen
    B.5.3 Address:
    B.5.3.1Street AddressJ.B Winsløws Vej 4, Indgang 7, stuen
    B.5.3.2Town/ cityOdense C
    B.5.3.3Post codeDK-5000
    B.5.3.4CountryDenmark
    B.5.4Telephone number+4528791991
    B.5.6E-mailviktoria.lindberg-larsen@rsyd.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 Dexavital
    D.2.1.1.2Name of the Marketing Authorisation holderVital Pharma Nordic ApS, c/o Ordnung
    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 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 INNDexametason
    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 number4
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Dysplasia of the hip
    E.1.1.1Medical condition in easily understood language
    Dysplasia of the hip
    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 LLT
    E.1.2Classification code 10063175
    E.1.2Term Hip dysplasia
    E.1.2System Organ Class 100000004850
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the effect of intravenous dexamethasone relative to placebo on cumulated postoperative morphine consumption from baseline to 48 hours in hip dysplasia patients undergoing PAO.
    E.2.2Secondary objectives of the trial
    To compare the effect of repeated doses of intravenous dexamethasone relative to a single dose on cumulated postoperative morphine consumption from baseline to 48 hours in hip dysplasia patients undergoing periacetabulary osteotomy (PAO).
    Furthermore, to evaluate postoperative nausea and vomiting and development in inflammatory markers from baseline to 48 hours postoperative.

    And, to determine if dexamethasone is superior to placebo for:
    - Perception of pain intensity postoperatively and need for supplemental analgesics
    - Prevalence and degree of postoperative nausea and vomiting, including antiemetic consumption
    - Patient-reported outcome measures (PROMs)
    - Perception of sleep quality
    - Mobilization postoperatively
    - Prevalence and degree of serious adverse events (SAE), e.g. complicating wound infection, which need antibiotic treatment or revision surgery.

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients undergoing periacetabular osteotomy due to symptomatic hip dysplasia (CE<25grader) or retroverted acetabulum (crossover and posterior wall sign)
    2. ≥ 18 years
    3. Females if fertile*: Verified negative s-HCG, usage of safe contraceptives** or surgical sterilisation.
    4. Patients who give their written informed consent to participating in the trial, after having fully understood the content of the protocol and restrictions.
    *Postmenopausal is defined as >12months amenorrhoea.
    **Safe contraceptives accepted: intrauterine device or hormone contraceptives.
    E.4Principal exclusion criteria
    1. Patients who cannot speak or understand Danish
    2. Allergy or contraindications to trial medication
    3. Spinal anaesthesia
    4. Second intervention carried out simultaneously (e.g. femur osteotomy)
    5. Patients with daily opioid consumption prior to surgery (tramadol and codeine accepted)
    6. Drug, medical abuse or weekly alcohol consumption beyond ≥7 (female) and ≥14 (men) units, respectively.
    7. Mental disability, anxiety disorder (active psychiatric disorder or consumption of tricyclic antidepressants)
    8. Diabetes diagnosed prior to inclusion
    9. Immune suppression therapy (e.g. systemic glucocorticoids)
    10. Kidney impairment (eGFR < 50ml/min) or liver disease (≥Child Pugh B)
    E.5 End points
    E.5.1Primary end point(s)
    Cumulated postoperative morphine consumption in milligrams (mg) after 48hours.
    E.5.1.1Timepoint(s) of evaluation of this end point
    48 hours
    E.5.2Secondary end point(s)
    A Postoperative pain intensity after 48 hrs. Evaluated at (i) rest and (ii) under the timed-up-and-go (TUG) procedure. Pain intensity is assessed using the visual analogue scale (VAS).
    B Cumulated consumption of opioids from 48hrs post operation to POD14.
    C Postoperative nausea, 4 point scale after 48hrs.
    D Cumulated antiemetic consumption in mg and drug will be assessed after 48hrs.
    E TUG test after 48hrs.
    F Number of patients with one or more serious adverse events (SAE)
    G Inflammatory markers
    E.5.2.1Timepoint(s) of evaluation of this end point
    A 48 hours
    B day 14 after day of surgery
    C 48 hours
    D 48 hours
    E 48 hours
    F 8 weeks
    G 48 hours
    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 Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    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 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
    LVLS
    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 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: 85
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 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 state90
    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)
    Except from IMP /placebo and postoperative patient administered morpfine pump, the treatment will follow standard treatment
    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 Decision2019-04-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-03-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-12-31
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