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    Summary
    EudraCT Number:2013-003365-34
    Sponsor's Protocol Code Number:Artralgia1
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2013-08-27
    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 ConcernedSweden - MPA
    A.2EudraCT number2013-003365-34
    A.3Full title of the trial
    Pain relief following an intra-articular single dose metylprednisolon vs. placebo on temporomandibular joint artralgia patientens. A randomized controlled blinded multicenter study.
    Smärtlindring efter en intra-artikulär injektion av metylprednisolon vs. placebo på patienter med artralgi i käkleden. En randomiserad kontrollerad blindad multicenter studie.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pain relief following a single dose metylprednisolon vs. placebo injected to the jaw joint in patientens with chronic joint pain. A randomized controlled blinded multicenter study.
    Smärtlindring efter en injektion av metylprednisolon vs. placebo på patienter med smärtande käkleder. En randomiserad kontrollerad blindad multicenter studie
    A.3.2Name or abbreviated title of the trial where available
    Metylprednisolon temporomandibular joint
    Metylprednisolon käkled
    A.4.1Sponsor's protocol code numberArtralgia1
    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 SponsorSpecialisttandvårdskliniken Västmanlands sjukhus Västerås
    B.1.3.4CountrySweden
    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 supportLandstinget Västmanland
    B.4.2CountrySweden
    B.4.1Name of organisation providing supportÖrebro Läns Landsting
    B.4.2CountrySweden
    B.4.1Name of organisation providing supportFolktandvården Stockholm AB
    B.4.2CountrySweden
    B.4.1Name of organisation providing supportLandstinget Sörmland
    B.4.2CountrySweden
    B.4.1Name of organisation providing supportRegionala forskningsrådet i Uppsala- och Örebroregionen
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSpecialisttandvårdskliniken Västmanlands sjukhus Västerås
    B.5.2Functional name of contact pointGöran Isacsson
    B.5.3 Address:
    B.5.3.1Street AddressIngång 27
    B.5.3.2Town/ cityVästerås
    B.5.3.3Post code72129
    B.5.3.4CountrySweden
    B.5.4Telephone number+46767766506
    B.5.6E-mailgoran.isacsson@ltv.se
    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 Depo-Medrol 40 mg/ml injektionsvätska, suspension
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraarticular 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
    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 placeboIntraarticular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Artralgia of the jaw joint
    Artralgi i käkleden.
    Deskriptiv klinisk diagnos med smärta från käke-ansikte och där det onda förvärras vid tuggning av seg och hård föda. Gapning är smärtsam
    E.1.1.1Medical condition in easily understood language
    Undefined pain from jaw joint
    Ospecifik smärta i käkleden.
    Deskriptiv klinisk diagnos med smärta från käke-ansikte och där det onda förvärras vid tuggning av seg och hård föda. Gapning är smärtsam
    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 primary objective is to evaluate the relief of pain at maximal mouth opening following a single dose intra-articular metylprednisolon (Depo-Medrol®) vs. placebo in patients with artralgia of the temporomandibular joint
    Målsättningen är att utvärdera graden av smärtlindring vid maximal gapning efter en engångsinjektion I.A. metylprednisolon (Depo-Medrol®) vs. placebo på patienter med käkledsartralgi en månad efter behandling
    E.2.2Secondary objectives of the trial
    The secondary objectivs are to evaluate the relief of jaw pain at rest, mouth opening, jaw function, the consequences of pain and the emotional influence following the treatment. Also the variability of pain 3 days before and 5 days after the treatment as well as during 3 days before end of a one month evaluation period is tracked.
    Sekundärt utvärderas smärtlindringen vid käkvila, gapförmåga, käkfunktion, konsekvensen av smärta, och inverkan på stämningstillståndet av smärtlindringen. Också smärtans variabilitet 3 dagar före, 5 dagar efter injektionen och under 3 dagar en månad efter behandlingen beskrivs.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    age 18 or above
    the diagnosis artralgia in one jaw joint
    understands Swedish verbally and in written
    signed informed concent
    • ålder > 18 år.
    • diagnosen artralgi i en käkled
    • förstår svenska muntligen och skriftligen
    • skriftligen gett sitt medgivande att delta
    E.4Principal exclusion criteria
    noise from affekted joint( clicking or crepitation)
    polyarthitis/connective tissue disease
    bilateral artralgia of jaw joint
    fibromylagia or other generalized pain
    ongoing virus or bacterial infection
    ongoing major restaurations in the mouth
    corticosteroid injection in affekted jaw joint past 6 months
    previous sugical intervention of affected jaw joint
    complex psychiatric or psychological condition
    hypersensitive to local anesthetics
    hypersensitive to metylprednisolone
    hemofilia
    • käkledsljud (knäppning eller krepitation)
    • polyartrit/bindvävssjukdom
    • bilateral artralgi
    • fibromyalgi eller annan generaliserad smärta
    • pågående virus- eller bakterieinfektion
    • pågående tandvårdsbehandling
    • kortikosteroidinjektion i käkleden de senaste sex månaderna
    • tidigare kirurgi av besvärande käkled
    • komplex psykiatrisk/psykologisk bild
    • överkänslighet mot lokalanestetika
    • överkänslighet mot metylprednisolon
    • hemofili
    E.5 End points
    E.5.1Primary end point(s)
    The differnce in VAS-rated pain intensity at maximal mouth opening from baseline to end of study
    Förändringen av VAS-skattad smärta vid maximal gapning mellan baseline och studieslut efter en månad.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After a month
    Efter en månad.
    E.5.2Secondary end point(s)
    The differnce in VAS-rated pain intensity at jaw rest from baseline to end of study
    Maximal opening without pain
    Maximal opening with pain
    Maximal assisted mouth opening
    Instruments
    JFLS
    GCPS
    PHQ-9
    PGIC
    Förändringen av VAS-skattad smärta vid käkvila
    Maximal gapning utan smärta
    Maximal gapning med smärta
    Maximal gapning med assistans

    Instrument
    JFLS: En 0- 10 gradig käkfunktionsskala med 20 frågor där patienten graderar sin begränsning av käkfunktionen senaste månaden.
    GCPS: Ett instrument med 8 frågor där patienten svarar på hur smärtan på en 0-10 gradig skala på 6 av frågorna har påverkat smärtan och dess konsekvenser. Två av frågorna tar upp durationen av smärtan.
    PHQ-9: Ett instrument med en 4-gradig skala och 9 frågor som beskriver stämningsläget hos patienten.
    PGIC: Ett instrument som används vid studiens slut och där patienten svarar på frågan "Hur har din smärta förändrats jämfört med tiden före injektionen? Patienten ringar in det som bäst beskriver situationen i genomsnitt" och markerar ett av 7 svarsalternativ "väldigt mycket bättre, mycket bättre, lite bättre, oförändrad, lite sämre, mycket sämre, väldigt mycket sämre
    E.5.2.1Timepoint(s) of evaluation of this end point
    After a month
    Efter en månad.
    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 Yes
    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 Yes
    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 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 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 concerned4
    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 years1
    E.8.9.1In the Member State concerned months2
    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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 14
    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 2013-08-27. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women Yes
    F.3.3.4Nursing women Yes
    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 state64
    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)
    Patients treated following the routine at the clinic with an algorithm adapted to the particular diagnose
    Patienterna behandlas enl den rutin som gäller på kliniken och den algoritm som är anpassad till den aktuella diagnosen
    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 Decision2013-10-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-10-09
    P. End of Trial
    P.End of Trial StatusOngoing
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