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    Summary
    EudraCT Number:2009-010008-27
    Sponsor's Protocol Code Number:F1J-MC-HMGP
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-04-27
    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 ConcernedGermany - BfArM
    A.2EudraCT number2009-010008-27
    A.3Full title of the trial
    Duloxetine 60 mg once daily versus Placebo in the Treatment of Patients with Osteoarthritis Knee Pain
    A.3.2Name or abbreviated title of the trial where available
    HMGP
    A.4.1Sponsor's protocol code numberF1J-MC-HMGP
    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 SponsorEli 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 Yes
    D.2.1.1.1Trade name Cymbalta
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Nederland BV
    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 nameduloxetine
    D.3.2Product code LY248686
    D.3.4Pharmaceutical form Gastro-resistant capsule, hard
    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 INNduloxetine
    D.3.9.1CAS number 116539594
    D.3.9.2Current sponsor codeLY248686
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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.IMP: 2
    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 Cymbalta
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Nederland BV
    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 nameduloxetine
    D.3.2Product code LY248686
    D.3.4Pharmaceutical form Gastro-resistant capsule, hard
    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 INNduloxetine
    D.3.9.1CAS number 116539594
    D.3.9.2Current sponsor codeLY248686
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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, hard
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    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
    Osteoarthritis Knee Pain
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    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 duloxetine 60 mg QD compared with placebo on the reduction of pain severity as measured by the Brief Pain Inventory (BPI) –
    Modified Short Form 24-hour average pain rating in patients with OA knee pain during a 13-week, double-blind, treatment period.
    E.2.2Secondary objectives of the trial
    Secondary Gatekeeper Objectives
    •To evaluate duloxetine 60 mg QD versus placebo on patients’ perceived
    improvement during the 13-week treatment period as measured byPGI – Improvement
    • To evaluate duloxetine 60 mg QD versus placebo on the change in patients’
    functioning during the 13-week treatment period as measured by the WOMAC physical function subscale
    Secondary Objectives
    • To assess the efficacy of duloxetine 60 mg QD versus placebo during the 13-week
    treatment period as measured by: CGI-Severity, WOMAC, BPI, Response to treatment, Sustained response to treatment, b-POMS
    • To assess the impact of treatment on patient-reported health outcomes, as
    measured by: SF-36, EQ-5D
    • To evaluate the safety of duloxetine 60 mg QD: discontinuation rates of patients, incidence of TEAEs, AEs and SAEs, changes in laboratory test values, changes in vital signs and weight,C–SSRS
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    [1] Are male or female outpatients at least 40 years of age.
    [2] Female patients: women of child-bearing potential who test negative
    for pregnancy at the time of enrollment based on a serum pregnancy
    test and agree to use a reliable method of birth control during the study
    and for 1 month following the last dose of study drug; OR women not
    of child-bearing potential due to surgical sterilization (hysterectomy or
    bilateral oophorectomy or tubal ligation) or menopause.
    [3] Meet the American College of Rheumatology (ACR) clinical and
    radiographic criteria for the diagnosis of OA of the knee
    [4] Have OA knee pain for ≥14 days of each month for 3 months prior to
    study entry.
    [5] Have a rating of greater than or equal to 4 on the BPI average pain
    item (Question 3 of the BPI modified short form) at both Visit 1 and
    Visit 2.
    [6] Have an education level and a degree of understanding such that the
    patient can communicate intelligibly with the site study personnel.
    [7] Are judged to be reliable and agree to keep all appointments for clinic
    visits, tests, and procedures required by the protocol.
    [8] Have agreed to maintain the same activity level throughout the course
    of the study. Continuation of long-term, regular, non-pharmacological
    treatments such as physical therapy or relaxation therapy is allowed.
    E.4Principal exclusion criteria
    [9] Are investigator site personnel directly affiliated with this study and/or their immediate families
    [10] Are employed by Lilly
    [11] Are currently enrolled in, or discontinued within the last 30 days from, a clinical study involving an off-label use of an investigational drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
    [12] Have previously completed or withdrawn from this study or any other
    study investigating duloxetine
    [13] Have had any previous exposure to duloxetine
    [14] Have any previous diagnosis of psychosis, bipolar disorder, or schizoaffective disorder
    [15] Have MDD as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, as assessed by the Mini International Neuropsychiatric Interview or diagnosed within the past year
    [16] Have a history of substance abuse or dependence within the past year
    [17] Are taking any excluded medications that cannot be discontinued at Visit 1
    [18] Have current or pending disability compensation or litigation issues that may compromise response to treatment, in the opinion of the investigator
    [19] Have had treatment with a MAOI within 14 days of randomization or the potential need to use an MAOI during the study or within 5 days of discontinuation of study drug.
    [20] Have a positive urine drug screen for any substance of abuse or
    excluded medication.
    [21] Are pregnant or breast-feeding
    [22] Have serious cardiovascular, hepatic, renal, respiratory, or hematologic illness, or other medical or psychiatric condition that, in the opinion of the investigator, would compromise participation or be likely to lead to hospitalization during the course of the study
    [23] Have a history of recurrent seizures other than febrile seizures
    [24] Are judged by the investigator to be at suicidal risk
    [25] Have uncontrolled narrow-angle glaucoma
    [26] Have acute liver injury or severe cirrhosis
    [27] Have known hypersensitivity to duloxetine or any of the inactive ingredients or patients with frequent or severe allergic reactions to multiple medications
    [28] Have frequent falls that could result in hospitalization or could compromise response to treatment
    [29] Have a confounding painful condition that may interfere with assessment of the index joint, that is, knee.
    [30] Have a diagnosis of inflammatory arthritis or an autoimmune disorder
    [31] Have received intrarticular hyaluronate or steroids, joint lavage, or other invasive therapies to the knee in the past 3 months
    [32] Have had knee arthroscopy of the index knee within the past year or
    joint replacement of the index knee at anytime
    [33] Have surgery planned during the study for the index joint
    [34] Have had a prior synovial fluid analysis showing a white blood cell
    (WBC) ≥2000 mm3 that is indicative of a diagnosis other than OA.
    [35] Are non-ambulatory or require the use of crutches or a walker.
    [36] Have a BMI over 40.
    [37] Use of acupuncture, chiropractic maneuvers, TENS
    [38] Patients who are anticipated by the investigator to require use of analgesic agents including but not limited to NSAIDs, acetaminophen/paracetamol, and opioids, or other excluded medication for the duration of the study.
    [39] Are unwilling or unable to comply with the data collection method used to record their patient rated outcome data.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy measure for this study is the BPI “24-hour average pain” item
    (Question 3) of the BPI – Modified Short Form. The BPI is a self-reported scale that measures the severity of pain and the interference of pain on function. For the BPI 24-hour average pain item, the ratings range from 0 (no pain) to 10 (pain as severe as you can imagine). Data will be collected at scheduled office visits.
    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 Yes
    E.6.13.1Other scope of the trial description
    Impact on patient-reported health outcomes
    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 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA17
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    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 Information not present in EudraCT
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 170
    F.4.2.2In the whole clinical trial 422
    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 Decision2009-06-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-08-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-05-20
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