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    The EU Clinical Trials Register currently displays   43881   clinical trials with a EudraCT protocol, of which   7295   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).

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    Summary
    EudraCT Number:2017-002119-33
    Sponsor's Protocol Code Number:2017-02
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-07-20
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2017-002119-33
    A.3Full title of the trial
    The PLUS study: Preventing LUmbar Disc Surgery
    PLUS studie: Het voorkomen van lumbale hernia operaties
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Combination therapy for preventing lumbar disc surgeries
    Combinatietherapie ter voorkoming van lumbale hernia operaties
    A.3.2Name or abbreviated title of the trial where available
    PLUS study
    PLUS studie
    A.4.1Sponsor's protocol code number2017-02
    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 SponsorZonMW
    B.1.3.4CountryNetherlands
    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 supportZonMW
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportRugpoli
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVU University Amsterdam
    B.5.2Functional name of contact pointMOVE Research Institute Amsterdam
    B.5.3 Address:
    B.5.3.1Street Addressvan der Boechorststraat 7
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1081BT
    B.5.3.4CountryNetherlands
    B.5.6E-mailmoveoffice.fbw@vu.nl
    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 Omnipaque
    D.2.1.1.2Name of the Marketing Authorisation holderGE Healthcare BV
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameOmnipaque
    D.3.2Product code RVG09819
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPEpidural 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.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 Yes
    D.3.11.13.1Other medicinal product typeContrast media
    D.IMP: 2
    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 Xylocaine (lidocaïnehydrochloride)
    D.2.1.1.2Name of the Marketing Authorisation holderFresenius Kabi Nederland BV
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameXylocaine
    D.3.2Product code RVG51674
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPEpidural 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.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 Yes
    D.3.11.13.1Other medicinal product typeLocal anesthetic
    D.IMP: 3
    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 Dexamethason
    D.2.1.1.2Name of the Marketing Authorisation holderCentrafarm BV
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameDexamethason
    D.3.2Product code RVG55091
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPEpidural 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.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 Yes
    D.3.11.13.1Other medicinal product typeSuppresses inflammation, and thus pain in sciatica patients
    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
    Lumbosacral Radicular Syndrome
    Lumbosacraal radiculair syndroom
    E.1.1.1Medical condition in easily understood language
    Sciatica
    Lage rug hernia
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10037739
    E.1.2Term R sciatica
    E.1.2System Organ Class 100000014640
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to assess the effectiveness and cost-effectiveness in terms of the number of surgeries prevented of a combination therapy versus usual care.
    De primaire doelstelling van dit onderzoek is om de effectiviteit en de kosteneffectiviteit in termen van het aantal voorkomen operaties te bepalen van een combinatietherapie in vergelijking met gebruikelijke zorg.
    E.2.2Secondary objectives of the trial
    The secondary objective of this study is to assess the effectiveness and cost-effectiveness in terms of pain (leg and back), functioning, self-perceived recovery and health-related quality of life of a combination therapy versus usual care.
    De secundaire doelstelling van dit onderzoek is om de effectiviteit en de kosteneffectiviteit in termen van pijn, functioneren, ervaren herstel, en kwaliteit van leven te bepalen van een combinatietherapie in vergelijking met gebruikelijke zorg.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    In order to be eligible to participate in this study, a subject must meet all of the following criteria:
    • Incapacitating lumbosacral radicular syndrome with leg pain (with or without back pain) that had lasted for a minimum of 6 weeks
    with or without mild neurological deficit (MRC higher than 3)
    • MRI which confirms a lumbar HNP that compromises the spinal nerve and can explain the clinical symptoms of the patient
    • The patients should according to usual care have an indication for lumbar HNP operation by a neurosurgeon.
    • Signed informed consent for participation in the study
    • 18 years and
    Om in aanmerking te komen voor deelname aan dit onderzoek, moet een patient aan de volgende criteria voldoen:
    • Invaliderende lumbosacraal radiculair syndroom met pijn in de benen (met of zonder rugpijn), met een duur van minimaal 6
    weken, met of zonder milde neurologische uitval (MRC groter dan 3)
    • MRI laat een lumbale HNP zien die de spinale zenuwen bekneld en de klinische symptomen van de patiënt kan verklaren
    • De patiënt moet volgens de “gebruikelijke zorg" in aanmerking komen voor neurochirurgische behandeling van de lumbale HNP.
    •Informed consent
    •18 jaar en ouder
    E.4Principal exclusion criteria
    A potentially eligible subject who meets any of the following criteria will be excluded from participation in this study:
    • Patients exclude suffering from cauda equina syndrome
    • Previous spine surgery at the same level during the previous 6 months
    • Previous transforminal injections at the same level during the previous 6 months
    • Bony stenosis
    • Spondylolisthesis
    • Pregnancy
    • Complicated disc herniation requiring more operations
    • Severe coexisting disease e.g. osteoporosis, dementia
    • Patient with contra-indications for steroids injections
    • Insufficient knowledge of the Dutch language
    • Emergency surgery as determined by the neurosurgeon
    • Severe paresis MRC less than or equal to 3
    • Being allergic for OMNIPAQUE 240
    Exclusiecriteria zijn:
    • Patiënten met caudasyndroom of stenose of spondylolisthesis
    • Vorige chirurgie van de wervelkolom op hetzelfde niveau in de voorgaande 6 maanden
    • Vorige transforminal injecties op hetzelfde niveau gedurende de 6 maanden
    • Zwangerschap
    • Gecompliceerde hernia
    • Ernstige ziekte, bijvoorbeeld osteoporose, dementie
    • Patiënt met contra-indicaties voor steroïden injecties
    • Onvoldoende kennis van de Nederlandse taal
    • Spoedoperatie zoals bepaald door de neurochirurg
    • Ernstige parese MRC kleiner dan of gelijk aan 3
    • Allergie voor het contrast medium OMNIPAQUE 240
    E.5 End points
    E.5.1Primary end point(s)
    Surgery rate (number of patients undergoing surgery during a 12-month follow-up)
    Herniaoperaties (aantal patiënten dat gedurende de follow-up periode een herniaoperatie ondergaat)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline and 2, 4, 6, 9 and 12 months
    Baseline en 2, 4, 6, 9 and 12 maanden
    E.5.2Secondary end point(s)
    Back and leg pain intensity (NPRS), physical functioning (RMDQ-23), self-perceived recovery (GPE), health-related quality of life (EQ-5D-5L) en societal costs.
    Rug- en beenpijn (NPRS), functioneren (RMDQ-23), ervaren herstel (GPE), kwaliteit van leven (EQ-5D-5L) en maatschappelijke kosten.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline, 4 weeks (only for pain), and 2, 4, 6, 9 and 12 months
    Baseline, 4 weken (enkel pijn) en 2, 4, 6, 9 and 12 maanden
    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 No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Cost-effectiveness analysis / Health Technology Assessment
    Kosteneffectiviteit / Doelmatigheidsonderzoek
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Gebruikelijke zorg
    Usual care
    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 concerned6
    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
    146 patients will be included. After the last inclusion, 12 months are required for follow-up.
    146 patienten worden geincludeerd. Na de laatste inclusie is nog een jaar follow-up nodig.
    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 months6
    E.8.9.1In the Member State concerned days
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 46
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2017-07-20. Yes
    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 state146
    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
    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 Decision2017-07-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-09-07
    P. End of Trial
    P.End of Trial StatusOngoing
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