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    Summary
    EudraCT Number:2013-000832-85
    Sponsor's Protocol Code Number:2013-000832-85
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2013-08-23
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2013-000832-85
    A.3Full title of the trial
    INTRAMUSCULAR CLODRONATE 200 MG IN THE THERAPY OF HANDS IN PHASE ALGIC OSTEOARTHROSIS - A 6 MONTHS PILOT OPEN STUDY.
    CLODRONATO INTRAMUSCOLARE 200 MG NELLA TERAPIA DELLA OSTEOARTROSI DELLE MANI IN FASE ALGICA - STUDIO PILOTA IN APERTO DELLA DURATA DI 6 MESI.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    INTRAMUSCULAR INJECTIONS OF CLODRONIC ACID IN THE FORMULATION OF 200 Mg IN THE TREATMENT OF HAND OSTEOARTHRITIS PAINFUL - FIRST STUDY TO EVALUATE THE ABILITY TO ACT DRUG IN IMPROVING SYMPTOMS OF DISEASE
    INIEZIONI INTRAMUSCOLARI DI ACIDO CLODRONICO NELLA FORMULAZIONE DA 200 Mg NELLA CURA DELL’ARTROSI DOLOROSA DELLE MANI- PRIMO STUDIO ATTO A VALUTARE LA CAPACITA’ DEL FARMACO NEL MIGLIORARE I SINTOMI DELLA MALATTIA
    A.3.2Name or abbreviated title of the trial where available
    ERODE 2
    ERODE 2
    A.4.1Sponsor's protocol code number2013-000832-85
    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 SponsorFondazione Salvatore Maugeri, IRCCS
    B.1.3.4CountryItaly
    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 supportFondazione Salvatore Maugeri, IRCCS
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFondazione Salvatore Maugeri, IRCCS
    B.5.2Functional name of contact pointUOS Reumatologia riabilitativa
    B.5.3 Address:
    B.5.3.1Street Addressvia Ospedale, 26
    B.5.3.2Town/ cityCastel Goffredo (MN)
    B.5.3.3Post codeI-46042
    B.5.3.4CountryItaly
    B.5.4Telephone number003937677471
    B.5.6E-mailgianantonio.saviola@fsm.it
    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 CLASTEON
    D.2.1.1.2Name of the Marketing Authorisation holderABIOGEN PHARMA SPA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameAcido clodronico
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular 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 typebisphosphonate + local anesthetic
    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
    Painful osteoarthritis of the hands
    Artrosi dolorosa delle mani
    E.1.1.1Medical condition in easily understood language
    Painful osteoarthritis of the hands
    Artrosi dolorosa delle mani
    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
    To evaluate the efficacy and tolerability of cyclic administration of 200 mg intramuscular injection of clodronate in patients with erosive osteoarthritis of the hands being algic and nodal osteoarthritis of the hands being algic measured by grip strength and the index of Dreiser
    Valutare l’efficacia e la tollerabilità della somministrazione ciclica intramuscolare di clodronato da 200 mg in pazienti affetti da osteoartrosi erosiva delle mani in fase algica e da osteoartrosi nodale delle mani in fase algica misurata attraverso la forza di presa e l’indice di Dreiser
    E.2.2Secondary objectives of the trial
    Effectiveness assessment of pain relief through the consumption of NSAID-pain relievers.
    Valutazione comparativa dell’efficacia antalgica attraverso il consumo di FANS-antidolorifici.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ° male and female population over 18 years
    ° erosive osteoarthritis diagnosed according to international radiological criteria (at least 2 interphalangeal joints in erosive phase) or primary osteoarthritis of the hands diagnosed according to clinical ACR steroid therapy and DMOADs any suspended for at least three months, including infiltration
    ° phase algic in place to load interphalangeal hands with VAS  4 cm/10
    ° maschi e femmine di popolazione superiore ai 18 anni
    ° osteoartrosi erosiva diagnosticata secondo criteri radiologici internazionali (almeno 2 articolazioni interfalangee in fase erosiva) o osteoartrosi primaria delle mani diagnosticata secondo i criteri clinici ACR terapia steroidea e DMOADs eventuale sospesa da almeno tre mesi, comprese infiltrazioni
    ° fase algica in atto a carico delle interfalangee delle mani con VAS  4 cm/10
    E.4Principal exclusion criteria
    ° erosive osteoarthritis and primary osteoarthritis in inactive phase and not algic
    ° with osteoarthritis of the hands with functional impairment no longer editable (ankylosis)
    ° patients with digestive diseases that contraindicate the use of NSAIDs
    ° suffering from kidney disease, cardiovascular and neoplastic
    ° suffering from systemic diseases and non-severe, not yet stabilized
    ° suffering from psychiatric and / or neurological relevant
    ° suffering from rheumatism, fibromyalgia primary or secondary
    ° syndromes of the upper canalicular
    ° suffering from chronic inflammatory arthropathy albeit temporarily in remission.
    ° those who take illegal drugs and / or alcohol in doses which constitute abuse.
    ° patients with known or suspected hypersensitivity to bisphosphonates
    ° subjects presenting contraindication to the use of NSAIDs
    ° subjects not willing to give their informed consent to participation in the study and patients who do not ensure adequate adherence to the study requires.
    ° patients who are pregnant or nursing, or who have good chance of it during the course of the study.
    ° affetti da osteoartrosi erosiva e osteoartrosi primaria in fase inattiva e non algica
    ° affetti da osteoartrosi delle mani con danno funzionale non più modificabile (anchilosi)
    ° pazienti affetti da patologie digestive che controindichino l’uso di FANS
    ° affetti da malattie renali, cardiovascolari e neoplastiche
    ° affetti da malattie sistemiche e non, di grado severo, non ancora stabilizzate
    ° affetti da malattie psichiatriche e/o neurologiche rilevanti
    ° affetti da reumatismo fibromialgico primario o secondario
    ° affetti da sindromi canalicolari dell’arto superiore
    ° affetti da artropatie infiammatorie croniche anche se temporaneamente in fase di remissione.
    ° soggetti che assumano sostanza stupefacenti e/o alcoolici in dosi tali da configurare abuso.
    ° soggetti con ipersensibilità accertata o presunta ai bisfosfonati
    ° soggetti che presentino controindicazione all’utilizzo di FANS
    ° soggetti non disposti a dare il proprio consenso informato di partecipazione allo studio e pazienti che non assicurino una adeguata aderenza a quanto lo studio richiede.
    ° pazienti in gravidanza o allattamento o che abbiano buona probabilità di esserlo durante lo svolgimento dello studio.
    E.5 End points
    E.5.1Primary end point(s)
    To evaluate the efficacy and tolerability of cyclic administration of 200 mg intramuscular injection of clodronate in patients with erosive osteoarthritis of the hands being algic and nodal osteoarthritis of the hands being algic measured by grip strength and the index of Dreiser
    Valutare l’efficacia e la tollerabilità della somministrazione ciclica intramuscolare di clodronato da 200 mg in pazienti affetti da osteoartrosi erosiva delle mani in fase algica e da osteoartrosi nodale delle mani in fase algica misurata attraverso la forza di presa e l’indice di Dreiser
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 month
    6 mesi
    E.5.2Secondary end point(s)
    Effectiveness assessment of pain relief through the consumption of NSAID-pain relievers.
    Valutazione comparativa dell’efficacia antalgica attraverso il consumo di FANS-antidolorifici.
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 month
    6 mesi
    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 No
    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 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 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.8.4.1Number of sites anticipated in Member State concerned1
    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 years0
    E.8.9.1In the Member State concerned months18
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months18
    E.8.9.2In all countries concerned by the trial 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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 Yes
    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 state60
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 60
    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)
    Best clinical practice
    Secondo regole di buona pratica clinica
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation FONDAZIONE SALVATORE MAUGERI, IRCCS
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-10-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-10-28
    P. End of Trial
    P.End of Trial StatusOngoing
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