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    Summary
    EudraCT Number:2015-001669-16
    Sponsor's Protocol Code Number:80-83600-98-3143
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2015-05-06
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2015-001669-16
    A.3Full title of the trial
    Duloxetine for chronic osteoarthritis pain; an important alternative?
    Duloxetine voor chronische pijn bij artrose; is het een belangrijk alternatief?
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Duloxetine for chronic osteoarthritis pain; an important alternative?
    Duloxetine voor chronische pijn bij artrose; is het een belangrijk alternatief?
    A.3.2Name or abbreviated title of the trial where available
    DUO-trial
    DUO-trial
    A.4.1Sponsor's protocol code number80-83600-98-3143
    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 SponsorErasmus MC
    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.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationErasmus MC
    B.5.2Functional name of contact pointDepartment of General Practice
    B.5.3 Address:
    B.5.3.1Street AddressP.O. Box 2040
    B.5.3.2Town/ cityRotterdam
    B.5.3.3Post code3000CA
    B.5.3.4CountryNetherlands
    B.5.6E-maild.schiphof@erasmusmc.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 Duloxetine
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly
    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.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral 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 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
    osteoarthritis
    artrose
    E.1.1.1Medical condition in easily understood language
    osteoarthritis
    artrose
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    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 proposal is to investigate if duloxetine is effective as a third choice pain medication for treating chronic pain in OA compared to usual care
    Deze studie wil antwoord geven op de vraag of duloxetine effectief is als derdelijns pijnmedicatie voor chronische pijn bij artrose in vergelijking met de gebruikelijke zorg (bij falen of contra-indicaties voor een NSAID).
    E.2.2Secondary objectives of the trial
    Furthermore, we will assess the cost-effectiveness of duloxetine treatment and if the presence of a neuropathic pain component favorably modifies the response to treatment and if the presence of a neuropathic component will be necessary for (cost-)effectiveness.
    Daarnaast zal worden gekeken of duloxetine kosteneffectief is. Tenslotte zal worden bekeken of de aanwezigheid van een neuropathische pijn component de respons op behandeling verbetert en of deze karakteristiek noodzakelijk is voor een kosteneffectieve behandeling.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) having hip or knee OA based on the clinical ACR criteria, and 2) having chronic pain (most days of the last three months) in hip or knee, and 3)either: (i) a contra-indication for NSAIDs, (ii) adverse reactions of NSAIDs; or (iii) insufficient benefit of NSAIDs.
    1) Heup- of knieartrosepatiënten (gebaseerd op de klinische ACR-criteria), met 2) chronische pijn (meeste dagen in de afgelopen 3 maanden) in de heup of knie en 3) (i) contra-indicatie voor NSAID's, (ii) bijwerkingen van NSAID's of (iii) onvoldoende effect NSAID's
    E.4Principal exclusion criteria
    1) on waiting list for hip/knee replacement, and 2) use of antidepressants and neuropathic pain medication 3) contra-indication of duloxetine (use of Monoamine Oxidase Inhibitors, having uncontrolled narrow-angle glaucoma, in combination with (other) central nervous system acting drugs, in combination with thioridazine, hypersensitivity to duloxetine, disturbed liver function, renal insufficiency (creatinine clearance <30 ml/min), usage of strong CYP1A2-inhibitors and CYP2D6-inhibitors and substrates)
    1) op de wachtlijst staan voor een nieuwe heup of knie, 2) gebruik van antidepressiva en neuropathische pijnmedicatie 3) contra-indicaties voor duloxetine (gebruik van Monoamine Oxidase Inhibitors, ongecontroleerde nauwe kamerhoek glaucoom, in combinatie met (andere) medicatie die op het centrale zenuwstelsel werkt, in combinatie met thioridazine of bij hypersensitiviteit voor duloxetine, gestoorde leverfunctie, ernstige nierfunctiestoornis (creatinine klaring <30 ml/min), gebruik van sterke CYP1A2-inhibitoren en CYP2D6-inhibitoren en substraten)
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome of this study will be pain at 3 months measured with the WOMAC pain subscale.
    De primaire uitkomstmaat is pijn na 3 maanden gemeten met de WOMAC pijn subscore.
    E.5.1.1Timepoint(s) of evaluation of this end point
    three months
    three months
    E.5.2Secondary end point(s)
    Secondary outcomes will be pain at one year (WOMAC pain subscale), disability (WOMAC function subscale), adverse reactions, quality of life, compliance to treatment, patients' satisfaction, OARSI-OMERACT, co-interventions, costs (iMCQ, iPCQ)
    Secundaire uitkomstmaten zijn pijnklachten na 1 jaar (WOMAC), lichamelijke beperkingen (WOMAC), bijwerkingen van duloxetine, kwaliteit van leven, medicatietrouw, patiënttevredenheid, OARSI-OMERACT responscriteria, co-interventies en kosten.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 year
    1 jaar
    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 No
    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.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    cluster gerandomiseerd
    cluster randomised
    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 voor chronische pijn bij artrose
    usual care for pain in chronic osteoarthritis
    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 concerned73
    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 months
    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: 112
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 112
    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 state224
    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
    Geen
    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 Decision2015-05-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-12-21
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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