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    Summary
    EudraCT Number:2018-001191-38
    Sponsor's Protocol Code Number:TYKS/LeLiBu/1-2
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-01-07
    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 ConcernedFinland - Fimea
    A.2EudraCT number2018-001191-38
    A.3Full title of the trial
    Levobupivacaine versus Liposomal Bupivacaine (Exparel®) for Treatment of Pain and Disability in Lateral Epicondylitis – Off-Label, Investigator Initiated Randomized, Controlled, Double-Blind Cross-Over Treatment Trial
    Levobupivakaiini- verrattuna Lipsomaaliseen Bupivakaiinipistokseen (Exparel) Tenniskyynärpäähän liittyvän kivun ja toimintakyvyn vajauksen hoidossa
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Levobupivacaine versus Liposomal Bupivacaine (Exparel®) for Treatment of Pain and Disability in Lateral Epicondylitis
    A.4.1Sponsor's protocol code numberTYKS/LeLiBu/1-2
    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 SponsorTurku University Hospital
    B.1.3.4CountryFinland
    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 supportTurku University Hospital
    B.4.2CountryFinland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTurku University Hospital
    B.5.2Functional name of contact pointTurku University Hospital
    B.5.3 Address:
    B.5.3.1Street AddressLuolavuorentie 2
    B.5.3.2Town/ cityTurku
    B.5.3.3Post code20701
    B.5.3.4CountryFinland
    B.5.6E-mailMarkus.Paakkonen@tyks.fi
    D. IMP Identification
    D.IMP: 1
    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 Chirocaine 5 mg/ml injektioneste, liuos / infuusiokonsentraatti, liuosta varten
    D.2.1.1.2Name of the Marketing Authorisation holderAbbVie Oy
    D.2.1.2Country which granted the Marketing AuthorisationFinland
    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/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLEVOBUPIVACAINE
    D.3.9.1CAS number 27262-47-1
    D.3.9.4EV Substance CodeSUB08464MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 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 Exparel (liposomal bupivacaine)
    D.2.1.1.2Name of the Marketing Authorisation holderPacira pharmaceuticals
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameExparel liposomal bupivacaine
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    Infiltration
    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
    Lateral epicondylitis
    Lateraalinen epikondyliitti
    E.1.1.1Medical condition in easily understood language
    Lateral epicondylitis / tennis elbow
    Tenniskyynärpää
    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
    Objective of the trial is to compare the effectiveness of injected levobupivacaine and liposomal bupivacaine in the treatment of pain and disability in patients with lateral epicondylitis.
    Tutkimuksen tarkoituksena on verrata levobupivakaiinin ja lipsosomaalisen bupivakaiinin (Exparel) vaikuttavuutta tenniskyynärpäähän liittyvän kivun ja toimintakyvyn vajauksen hoidossa.
    E.2.2Secondary objectives of the trial
    Not applicable
    Ei käytössä
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -age 18-65
    -employed
    -chronic lateral epicondylitis (duration >3 months)
    -pain in lateral epicondyle
    -pain in resisted wrist extension in elbow extension (Cozen test)
    -X-ray or Magnetic resonance imaging (MRI) of the elbow (<12 months from enrollment) with no pathological findings other than lateral epicondylitis
    -18-65 vuoden ikä
    -työllistetty
    -krooninen tenniskyynärpää (oireet yli 3 kuukautta)
    -Kipu vastustetussa ranteen ojennuksessa kyynärpää suorana (Cozenin testi)
    -Tuore (<12kk) röntgen tai magneettikuva kyynärpäästä, jossa ei todeta muita patologisia muutoksia kuin tenniskyynärpään löydökset
    E.4Principal exclusion criteria
    -pregnancy
    -unemployment
    -allergy to levobupivacaine, bupivacaine or liposomal bupivacaine
    -constant use of strong analgesics (e.g. opioids)
    -other source of elbow pain (e.g. medial epicondylitis, distal biceps/triceps tendinitis)
    -bilateral epicondylitis
    -inability to give informed consent
    -inability to understand the enrollment forms or to fill patient diary (forms are written in Finnish)
    -previous injection treatment (e.g. cortisone, botulin toxin A, autologous plasma) for lateral epicondylitis during the past 3 months
    -severe hepatic disease, or other underlying severe illness (cardiac failure, cancer, other systemic diseases)
    -raskaus
    -työttömyys
    -allergia (levobupivakaiini, bupivakaiini tai liposomaalinen bupivakaiini)
    -vahvojen kipulääkkeiden käyttö pitkäaikainen käyttö
    - kyynärpääkivun muut lähteet
    - bilateraalinen epikondyliitti
    - ei pysty antaa suostumusta tutkimukseen
    - ei pysty täyttämään tai vastaamaan tutkimuskaavakkeisiin
    - saanut injektiohoidon kyynärpääkipuun viimeisen 3kk sisällä
    - Tutkittavalla vakava sairaus
    E.5 End points
    E.5.1Primary end point(s)
    reduction in pain reported by VAS
    Kivun lievitys mitattuna VAS asteikolla
    E.5.1.1Timepoint(s) of evaluation of this end point
    D0: before injection therapy
    1 week
    1 month

    Repeated for the second treatment
    Päivä 0: ennen injektiohoitoa
    1 viikko
    1 kuukausi

    Tositetaan toiselle hoidolle
    E.5.2Secondary end point(s)
    Oxford Elbow Score (OES)
    QuickDash
    time off work due to epicondylagia in days
    reduction in consumption of pain medication
    Oxford Elbow Score (OES)
    QuickDash
    Poissaolopäivät töistä kivun vuoksi
    Kipulääkkeiden käytön vähentyminen
    E.5.2.1Timepoint(s) of evaluation of this end point
    D0: before injection therapy
    1 week
    1 month

    Repeated for the second treatment
    Päivä 0: ennen injektiohoitoa
    1 viikko
    1 kuukausi

    Tositetaan toiselle hoidolle
    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) 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 No
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    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 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
    Viimeisen tutkittavan viimeinen käynti
    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: 50
    F.1.3Elderly (>=65 years) No
    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 state50
    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
    Ei erityis suunnitelmia
    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 Decision2020-03-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-01-21
    P. End of Trial
    P.End of Trial StatusOngoing
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