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    Summary
    EudraCT Number:2011-004046-18
    Sponsor's Protocol Code Number:CL3-12911-040
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-02-23
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2011-004046-18
    A.3Full title of the trial
    Knee joint replacement over 5 years in patients with knee osteoarthritis. A long term follow up study in patients of the CL3-12911-018 study.
    Artroplastia de rodilla a lo largo de 5 años en pacientes con artrosis de rodilla. Estudio de seguimiento a largo plazo en pacientes del estudio CL3-12911-018
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Knee joint replacement follow up study in patients with knee osteoarthritis which participated to the CL3-12911-018 study.
    Estudio de seguimiento de la artroplastia de rodilla en pacientes del estudio CL3-12911-018.
    A.4.1Sponsor's protocol code numberCL3-12911-040
    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 SponsorLaboratorios Servier
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportLaboratorios Servier
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLaboratorios Servier
    B.5.2Functional name of contact pointLaura Velasco
    B.5.3 Address:
    B.5.3.1Street AddressAvda de los Madroños, 33
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28043
    B.5.3.4CountrySpain
    B.5.4Telephone number0034917489018NA
    B.5.5Fax number0034913003249NA
    B.5.6E-maillaura.velasco@es.netrgs.com
    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 PROTELOS
    D.2.1.1.2Name of the Marketing Authorisation holderLes Laboratoires Servier
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameS12911
    D.3.2Product code S12911
    D.3.4Pharmaceutical form Granules for oral suspension
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNstrontium ranelate
    D.3.9.1CAS number 135459-87-9
    D.3.9.2Current sponsor codeS12911
    D.3.9.3Other descriptive nameSTRONTIUM RANELATE
    D.3.9.4EV Substance CodeSUB20045
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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

    The medical condition investigated in the CL3-12911-018 study was osteoarthritis. The applied CL3-12911-040 trial, CL3-12911-018 follow-up study, is thus performed in osteoarthritic patients.
    Artrosis

    La indicación médica que fue investigada en el estudio CL3-12911-018 fue artrosis. El actual estucio, CL3-12911-040, es el estudio de seguimiento del estudio CL3-12911-018, el cual se realizó en pacientes con artrosis.
    E.1.1.1Medical condition in easily understood language
    Osteoarthritis
    Artrosis
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10031161
    E.1.2Term Osteoarthritis
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To collect data on knee joint replacement procedures or procedures practiced in the knee (arthroscopy, osteotomy or other) over 5 years in patients with knee osteoarthritis having participated in the CL3-12911-018 study and having received at least one year (365 days) of CL3-12911-018 study treatment (Strontium Ranelate 1g/2g or placebo).
    Recoger datos sobre los procedimientos de artroplastia de rodilla o procedimientos realizados en la rodilla (artroscopia, osteotomía u otros) a lo largo de 5 años en pacientes con artrosis de rodilla, que hayan participado en el estudio CL3-12911-018 y que hayan recibido al menos durante un año (365 días) tratamiento del estudio CL3-12911-018 (Ranelato de Estroncio1g/2g o placebo).
    E.2.2Secondary objectives of the trial
    NA
    No aplicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients included in the CL3-12911-018 study and having received the CL3-12911-018 study treatment (Strontium Ranelate 1g/2g or placebo) for at least one year (at least 365 days of treatment during the CL3-12911-018 study).
    Los pacientes incluidos en el estudio CL3-12911-018 y que hayan recibido el tratamiento del estudio CL3-12911-018 (Ranelato de Estroncio1 gr/2gr o placebo) durante al menos un año (al menos 365 días de tratamiento durante el estudio CL3-12911-018)
    E.4Principal exclusion criteria
    Unlikely to cooperate in the study (such as patients suffering from dementia).
    Patients unable to provide the information requested by the study.
    Refusal to provide the study?s informed consent.
    -Poca probabilidad de cooperación en el estudio (como pacientes con demencia)
    -Pacientes incapaces de proporcionar la información requerida por el estudio.
    -Pacientes que rechazen proporcionar su consentimiento informado al estudio.
    E.5 End points
    E.5.1Primary end point(s)
    - Knee joint replacement in the target knee (knee followed in the CL3-12911-018 study).
    - Knee surgery or other procedure (arthroscopy, osteotomy or other).
    -Número artroplastia de rodilla en la rodilla objetivo (rodilla seguida en el estudio CL3-12911-018)
    -Número de cirugías u otros procedimientos (artroscopia, osteotomía u otros).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Each 12 months.
    Cada 12 meses.
    E.5.2Secondary end point(s)
    NA
    no aplicable
    E.5.2.1Timepoint(s) of evaluation of this end point
    NA
    no aplicable
    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
    Follow-up study without treatment administration
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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 trial0
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA71
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Canada
    Russian Federation
    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
    Last Visit Last Participant as stated in the protocol.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months7
    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: 772
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 434
    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 state136
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 1206
    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)
    No study drug will be used. This is a study that will not affect the physician?s decision regarding the treatment to use on each individual patient.
    No se administrará ningún tratamiento del estudio en este estudio. Este estudio no modifica la práctica médica, los fármacos se prescribirán solamente como resultado de la evaluación clínica normal.
    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 Decision2012-04-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-04-16
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2014-06-30
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