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    Summary
    EudraCT Number:2009-014516-35
    Sponsor's Protocol Code Number:L00023 GE 303
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-11-12
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2009-014516-35
    A.3Full title of the trial
    EFFICACY AND TOLERABILITY OF CHONDROITIN SULPHATE 1000MG, TWICE DAILY IN PATIENTS WITH SYMPTOMATIC KNEE OSTEOARTHRITIS
    A.4.1Sponsor's protocol code numberL00023 GE 303
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorPIERRE FABRE MEDICAMENT
    B.1.3.4CountryFrance
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 STRUCTUM
    D.2.1.1.2Name of the Marketing Authorisation holderPIERRE FABRE MEDICAMENT
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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.3.2Product code L0023 GE
    D.3.4Pharmaceutical form Capsule*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNChondroitin sulfate sodium
    D.3.9.1CAS number 9082-07-09
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Yes
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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 placeboCapsule*
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Symptomatic knee osteoarthtitis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10023476
    E.1.2Term Knee osteoarthritis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of chondroitin sulfate 1000 mg twice daily on pain relief and additionally functional improvement in patients with symptomatic knee OA at 6 months.
    E.2.2Secondary objectives of the trial
    - To assess the efficacy over 12 months on :
    *Patient’s and investigator’s global assessment of the disease status
    *Consumptions of analgesic medication (including NSAIDs)
    *Improvement in the patient's health related quality of life
    *Pain relief and functional improvement

    - To evaluate :
    *Safety and tolerability of the studied product over 12 months
    *Structural changes over 12 months
    *Biological tolerance over 12 months
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    To be included in the trial, patients should fulfill the following criteria:

    *male or female between 50 and 75 years of age

    *presenting with medial femorotibial OA of the knee fulfilling ACR criteria (knee pain + crepitus + morning stiffness < 30 minutes)
    - evolving for more than 6 months
    - with a Womac pain score greater than or equal to 45 on a 100mm VAS
    - patients taking analgesic medications for at least 3 months prior to inclusion and dissatisfied with their current therapy
    - with a grade II or III according to the Kellgren and Lawrence radiological classification(1) on a posterio-anterior weight-bearing X-ray image of both knees performed at screening visit

    *having given their written consent to take part in the study

    *covered by social security or a health insurance policy (if required by local requirements).
    E.4Principal exclusion criteria
    Patients fulfilling at least one of the following criteria cannot be included in the study:

    * Disease-related criteria:
    - isolated symptomatic femoropatellar osteoarthritis or isolated lateral femorotibial OA of the knee
    - Paget's disease of bone, chondromatosis or villonodular synovitis
    - symptomatic hip OA
    - inflammatory, infectious or metabolic arthritis (rheumatoid arthritis, ankylosing spondylitis, abarticular rheumatism…)
    - hemochromatosis, ochronosis or hemophilia
    - history of disease (except OA) which the investigator considers likely to interfere with the assessment of the functional disability
    - Anticipated surgery of the knee during the course of the study

    * Previous or concomitant treatment-related criteria:
    - patient having taken a symptomatic slow-acting drug for OA (SYSADOA) or a dietary supplement containing glucosamine, chondroitin sulphate, diacerhein or avocado-soybeans extracts in the 3 months preceding inclusion
    - patient having taken bisphosphonates or strontium ranelate in the 3 months preceding inclusion
    - patient having received any systemic corticosteroid treatment by any administration route during the month preceding inclusion
    - patient having received intra-articular steroid injection in the target knee in the 2 months preceding inclusion or patient having received intra-articular hyaluronic acid in the target knee in the 6 months preceding inclusion
    - patient having taken NSAIDs (except aspirin up to 325 mg/day for cardiovascular prophylactic) in the 2 days preceding inclusion (including topical application surrounding the target knee) or paracetamol in the 24 hours preceding inclusion
    - patient having undergone surgery (osteotomy, extra-articular ligamentoplasty, knee replacement, etc.) on the target knee
    - patient having undergone articular lavage of target knee in the 3 months preceding inclusion
    - patient with a known allergy to the study medication or one of its constituents
    - patient requiring regular or intermittent steroid therapy.

    * Patient-related criteria:
    - Body mass index (BMI) greater than or equal to 35
    - immunocompromised patient or patient presenting with a serious or progressive disease (cardiac, pulmonary, hepatic, renal, hematological, neoplastic or infectious disease)
    - patient presenting with a severe acute or chronic disease which the investigator deems incompatible with study implementation
    - patient presenting laboratory test results out of acceptable ranges and considered as clinically significant by the investigator performed at screening
    - patient presenting with a disease which the investigator considers likely to interfere with the study results or to expose the patient to additional risk
    - patient liable not to comply with protocol instructions and/or with treatment, in the investigator's opinion
    - patient having taken part in a clinical trial in the preceding 30 days or taking part in a trial at the time of inclusion
    - patient linguistically or psychologically unable to understand and sign the consent form
    - For women:
    o pregnant, breast feeding or likely to become pregnant during the time of the study
    o women with childbearing potential not using effective contraception (oral contraceptive formulations, intrauterine device, tubal ligation or other efficient procedures)

    * Rescue medication-related criteria:
    - patient with hypersensitivity to paracetamol.
    E.5 End points
    E.5.1Primary end point(s)
    Comparison at month 6 between the L0023 GE and Reference groups of the percentage of pain responders (patients with reduction of Womac pain score from baseline of ≥ 30 %), and additionally of function responders (patients with reduction of Womac function score from baseline of ≥ 20 %),
    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) 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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.8.3 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 Yes
    E.8.5.1Number of sites anticipated in the EEA38
    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 Information not present in EudraCT
    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 of last patient
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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.1.3Elderly (>=65 years) Yes
    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 No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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.4.2 For a multinational trial
    F.4.2.1In the EEA 460
    F.4.2.2In the whole clinical trial 460
    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 Decision2010-01-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-11-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-07-04
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