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    Summary
    EudraCT Number:2010-024320-23
    Sponsor's Protocol Code Number:I4F-EW-CCAC
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-02-17
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2010-024320-23
    A.3Full title of the trial
    A Proof-of-Concept Study of the Effects of LY2828360 in the Treatment of Patients with Osteoarthritic Knee Pain
    A.3.2Name or abbreviated title of the trial where available
    CCAC
    A.4.1Sponsor's protocol code numberI4F-EW-CCAC
    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 SponsorChorus, Eli Lilly and Company
    B.1.3.4CountryUnited States
    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 No
    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 nameLY2828360
    D.3.2Product code LY2828360
    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.3.9.2Current sponsor codeLY2828360
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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) 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 No
    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
    Pain in osteoarthritic knee.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level LLT
    E.1.2Classification code 10049475
    E.1.2Term Chronic pain
    E.1.2System Organ Class 10018065 - General disorders and administration site conditions
    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 safety and efficacy of 80 mg daily administration of LY2828360 compared to placebo on the change from baseline of pain severity (average pain scores (APS)).
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of 80 mg LY2828360 once a day (q.d.) versus placebo during the 4-week treatment phase on the change from baseline of secondary efficacy measures.
    To assess the safety of 80 mg LY2828360 q.d. versus placebo during the treatment phase.
    To assess the Pharmacokinetics (PK) of LY2828360 in OA patients.
    To investigate the relationship between exposure of LY2828360 and efficacy.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    [1] Are male or female patients with OA, as determined by medical history and physical examination. Males and females with stable medical problems that,
    in the investigator’s opinion, will not significantly alter the disposition of the
    drug, will not place the patient at increased risk by participating in the study,
    and will not interfere with interpretation of the data.
    a Male patients: agree to use a reliable method of birth control during the
    study and for 3 months following the last dose of the investigational
    product.
    b Female patients: women not of child-bearing potential due to surgical
    sterilization (at least 6 weeks post surgical bilateral oophorectomy with
    or without hysterectomy or tubal ligation) confirmed by medical history,
    or menopause.
    Postmenopausal women: Women with an intact uterus are deemed
    postmenopausal if they have had cessation of menses for at least 1 year with
    follicle-stimulating hormone (FSH) and oestradiol values compatible with
    postmenopausal status, age ≥45 years old, and not taking oral contraceptives
    within the last year.
    [2] Between 40 and 75 years of age and body weight greater >40 kg and <120 kg
    with a BMI between 19-35 kg/m2 inclusive.
    [3] Patient with osteoarthritic knee based on disease diagnostic criteria as
    presented in the Inclusion Disease Criteria, below.
    [4] Blood pressure and pulse rate in supine and standing positions, within normal
    reference ranges for the population and investigator CRU, or results with
    acceptable deviations that are judged to be not clinically significant by the
    investigator.
    [5] Have clinical laboratory test results within normal reference range for the
    population or investigator CRU, or results with acceptable deviations that are
    judged to be not clinically significant by the investigator.
    [6] Have venous access sufficient to allow for blood sampling as per the
    protocol.
    [7] Are reliable and willing to make themselves available for the duration of the
    study and are willing to follow study procedures.
    [8] Have agreed to maintain the same activity level throughout the course of the
    study.
    [9] Have given freely informed consent approved by Chorus, LRL or designee
    and the ethical review board (ERB) governing the CRU to participate in the
    study and willing to abide by the study restrictions
    [10] Have a unilateral or bilateral OA of the knee diagnosed according to the
    American College of Rheumatology (ACR) criteria based on clinical and
    radiographic evidence (Altman et al. 1986). The clinical diagnosis of OA
    will be confirmed by the ACR clinical and radiographic criteria for
    classification of idiopathic OA of the knee based upon the following criteria:
    a. Knee pain for at least 14 days per month for the 3 months before
    screening visit.
    b. Osteophytes (with radiographic evidence).
    c. At least 1 of the following 3 conditions: Age >50, or Morning stiffness
    <30 minutes, or Crepitus.
    d. If the patient has had an X-ray of the index joint within the last year
    which can confirm the diagnosis it may be used, otherwise a new
    anterior-posterior view x-ray should be obtained and reviewed by
    Principal Investigator or his delegates to verify that the patient meets the
    disease diagnostic criteria.
    [11] Have a Kellgren and Lawrence grade of I, II, III or IV.
    [12] Have a mean score of at least 4 (moderate) and less than or equal to 8
    (moderate-severe) on the 24-hour average pain score (0-10) (question 1) in
    the patient e-diary from Visit 2 to Visit 3 for the knee joint during walking.
    [13] Discontinued use of all analgesic medications (including over-the-counter
    [OTC] analgesics/ Non-Steroidal Anti-Inflammatory Drug (NSAID) at least 2
    weeks prior to randomization (patients are allowed limited use of analgesic
    medications).
    E.4Principal exclusion criteria
     Have an abnormality in the 12-lead ECG at screening that, in the opinion of
    the investigator, increases the risks associated with participation in the study.
    In addition, patients with following findings will be excluded:
    - Confirmed Bazett’s corrected QT (QTcB) interval > 450 msec for men and
    > 470 msec for women in 2 of 3 ECGs; additional ECGs may be performed if
    required,
    - Bundle branch blocks and other conduction abnormalities other than mild
    first degree atrio-ventricular block,
    - Irregular rhythms other than sinus arrhythmia or occasional, rare
    supraventricular or rare ventricular ectopic beats,
    - History of unexplained syncope,
    - Family history of unexplained sudden death or sudden death due to long QT
    syndrome,
    - T-wave configurations are not of sufficient quality for assessing QT interval
    determination, as assessed by the investigator.
     Have current or previous (within the past year) Axis 1 diagnosis of major
    depressive disorder, mania, bipolar disorder, psychosis, dysthymia,
    generalized anxiety disorder, alcohol or eating disorders according to
    “Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Text
    Revision” (DSM-IV; APA 2000) criteria, as determined by the investigator
    and confirmed by the Mini-International Neuropsychiatric Interview (MINI,
    Sheehan et al. 1998)).
     Are judged by the Principal Investigator to be clinically at suicidal risk based
    upon clinical interview (Columbia-Suicide Severity Rating Scale (C-SSRS)).
     Have an alanine aminotransaminase (ALT) >2.5 times Upper Limit of
    Normal (ULN) at Visit 1, based on reference ranges of the local laboratory.
    Moderate or greater hepatic impairment.
     Have prior renal transplant, current renal dialysis or severe renal insufficiency
    (creatinine clearance of <30 mL/min), or serum creatinine laboratory value
    >1.5 times ULN, based on the reference ranges of the local laboratory.
     Have a history of or symptoms suggestive of sleep apnoea.
     Use of any known strong inducers or inhibitors of Cytochrome P450
    (CYP450) within 30 days prior to enrolment.
     Are at a high risk of infection (e.g. leg ulcers, indwelling urinary catheter and
    persistent or recurrent chest infections and patients who are permanently bed
    ridden or wheelchair bound).
     Have an autoimmune disorder.
     Have secondary causes of arthritis of the knee including septic arthritis,
    inflammatory joint disease, articular fracture, major dysplasias or congenital
    abnormality, ochronosis, acromegaly, hemochromatosis, Wilson's disease,
    and primary osteochondromatosis.
     Have had lower extremity surgery (including arthroscopy of the index knee)
    within 6 months prior to Visit 1 or have surgery planned of the index knee at
    anytime.
     Have had significant prior injury to the index knee within 12 months prior to
    Visit 1.
    Use of lower extremity assistive devices other than a cane or knee brace (use
    of a 'shoe lift' is permitted). Are non-ambulatory or require the use of crutches
    or a walker. Use of a cane in the hand opposite the index knee is acceptable.
     Has had a prior synovial fluid analysis showing a White Blood Cell (WBC)
    ≥2000 mm3 that is indicative of a diagnosis other than OA.
     Have a confounding painful condition that may interfere with assessment of
    the index joint, i.e., knee. (Knee pain should be the predominant pain. Mild
    OA of the hands is allowed, for instance).
     Have any other musculoskeletal or arthritic condition that may affect the
    interpretation of clinical efficacy and/or safety data or otherwise
    contraindicates participation in this clinical study (i.e., currently symptomatic
    fractures or any concurrent rheumatic disease such as but not limited to
    fibromyalgia, rheumatoid arthritis, gout, pseudo-gout or Paget's disease and
    Reiter's syndrome are excluded).
     Have used corticosteroid prior to baseline:
    a. Intra-articular injection of steroids to the index knee or into any other
    site than the index knee within the previous 3 months.
    b. Intra-muscular corticosteroid injections within the previous 3 months.
    c. Oral corticosteroids within the previous 1 month.
    Have received hyaluronan injections into index knee within the previous 6
    months prior to Visit 3.
     Have started recently or have changed dose regimen (≤3 months prior to Visit
    3) of any OA specific therapies (i.e., nutraceutical products).
     Have initiated or have changed to an established physiotherapy program
    within 2 weeks prior to Visit 3 or during the study period. An established
    physiotherapy program may be continued throughout the study period if
    unchanged in frequency and intensity.
    E.5 End points
    E.5.1Primary end point(s)
    Safety: Discontinuation rates, Treatment Emergent Adverse Events (TEAEs), Rescue medication, Laboratory assessments, Vital Signs (VS), Electrocardiograms (ECGs), Subjective Liking Visual Analogue Scales (SL-VAS), Addiction Research Center Inventory (ARCI) and Subjective questionnaire (Columbia-Suicide Severity Rating
    Scale (C-SSRS).
    Bioanalytical: Plasma samples to determine LY2828360 concentrations.
    Pharmacokinetic/Pharmacodynamic: Relationship between exposure of LY2828360 and efficacy.
    Efficacy: Change from baseline of pain severity as measured by the weekly mean of the daily 24-hour APS, night pain and worst daily pain, Chronic Pain Sleep Inventory (CPSI), Brief Pain Inventory (BPI), Western Ontario and MacMaster (WOMAC) OA physical function, Time and Pain intensity from the 40 m self-paced walk test, Time
    and Pain intensity from the 11 step stair climb test, Pittsburgh Sleep Quality Index (PSQI), Investigator and Patient Global Assessment of Changes (IGAC and PGAC) and DoloTest®.
    Exploratory measures: Change from baseline of EPMs: quantitative sensory testing of joint, spreading sensitization
    and clinical pain areas, wind-up like pain and descending noxious inhibitory control.
    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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Proof of concept; Investigator blind; Subject Blind; Sponsor open
    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.8.5The 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 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
    End of study (trial) is defined as the date of the last visit or last scheduled procedure at the last CRU shown in the Study Schedule for the last active patient in the study.
    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 months5
    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 months0
    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 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 state44
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 0
    F.4.2.2In the whole clinical trial 0
    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 Decision2011-03-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-03-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-09-13
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