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    Summary
    EudraCT Number:2006-003485-33
    Sponsor's Protocol Code Number:F1J-MC-HMFG
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-01-02
    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 ConcernedGreece - EOF
    A.2EudraCT number2006-003485-33
    A.3Full title of the trial
    Duloxetine 60 to 120 mg versus Placebo in the Treatment of Patients with Osteoarthritis Knee Pain
    A.3.2Name or abbreviated title of the trial where available
    HMFG
    A.4.1Sponsor's protocol code numberF1J-MC-HMFG
    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 Limited
    B.1.3.4CountryUnited Kingdom
    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.3.4Pharmaceutical 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.3.4Pharmaceutical 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 placeboGastro-resistant capsule, 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 8.1
    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
    The primary objective is to assess the efficacy of duloxetine 60 to 120 mg once daily (QD) compared with placebo on the reduction of pain severity as measured by the Brief Pain Inventory (BPI) 24-hour average pain scores (for simplicity, it is referred to as the BPI average pain score hereafter) in patients with osteoarthritis (OA) knee pain during a 13-week, double-blind, treatment period.
    E.2.2Secondary objectives of the trial
    Evaluate duloxetine 60 to 120 mg QD vs placebo on patients’ perceived improvement during the 13-week treatment phase.
    Evaluate duloxetine 60 to 120 mg QD vs placebo on the change in patients’ functioning during the 13-week treatment phase.
    Assess the efficacy of duloxetine 60 to 120 mg QD v placebo during the 13-week treatment phase.
    Assess the impact of treatment with duloxetine 60 to 120 mg QD vs placebo during the 13-week treatment phase on patient-reported health outcomes.
    Evaluate whether reduction in pain is a direct analgesic effect of duloxetine and is independent of treatment effect on mood.
    Assess the safety of duloxetine vs placebo during the treatment phase on discontinuation rates, treatment-emergent adverse events (TEAEs), laboratory assessments, and vital signs.
    Assess the effect of treatment with duloxetine 120 mg QD in patients who did not respond to duloxetine 60 mg for 6 weeks.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Are male or female outpatients at least 40 years of age.
    - Meet the American College of Rheumatology (ACR) clinical and radiographic criteria for the diagnosis of osteoarthritis (OA) of the knee with pain for greater or equal to 14 days of each month for 3 months prior to study entry.
    - Have a mean score of 4 or greater on the 24-hour average pain score (0-10).
    - Are female of child-bearing potential (not surgically sterilized and between menarche and 1 year postmenopause) who are not breastfeeding and test negative for pregnancy at Visit 1 or are postmenopausal. Females must agree to utilize medically acceptable and reliable means of birth control as determined by the investigator during the study and for 1 month following the last dose of the study.
    - Have an educational level and degree of understanding such that the patient can communicate intelligibly with the investigator and study coordinator.
    - Are judged to be reliable and agree to keep all appointments for clinic visits, tests, and procedures required by the protocol.
    - Have agreed to maintain the same activity level throughout the course of the study.
    - Have completed the daily diaries for at least 70% of the days between Visit 1 and Visit 2.
    E.4Principal exclusion criteria
    - Are investigator site personnel directly affiliated with the study, or are immediate family of investigator site personnel directly affiliated with the study. “Immediate family” is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
    - Are employed by Lilly (that is, employees, temporary contract workers, or designees responsible for the conduct of the study).
    - Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry (Visit 1).
    - Have previously completed or withdrawn from this study or any other study investigating duloxetine.
    - Have had previous exposure to duloxetine.
    - Have any previous diagnosis of psychosis, bipolar disorder, or schizoaffective disorder.
    - Have major depressive disorder (MDD) as determined using depression module of the Mini International Neuropsychiatric Interview (MINI).
    - Have a history of substance abuse or dependence within the past year, excluding nicotine and caffeine.
    - Are taking any excluded medications that cannot be discontinued at Visit 1.
    - Have disability compensation or litigation issues that may compromise response to treatment, in the opinion of the investigator.
    - Have had treatment with a monoamine oxidase inhibitor (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.
    - Have a positive urine drug screen for any substance of abuse or excluded medication.
    - Are pregnant or breast-feeding.
    - 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.
    - Have a history of recurrent seizures other than febrile seizures.
    - Are judged clinically by the investigator to be at suicidal risk or as identified by a score of 2 or greater on question 9 of the Beck Depression Inventory-II (BDI-II) prior to starting study drug.
    - Have uncontrolled narrow-angle glaucoma.
    - Have acute liver injury (such as hepatitis) or severe cirrhosis (Child-Pugh Class C).
    - Have known hypersensitivity to duloxetine or any of the inactive ingredients or patients with frequent or severe allergic reactions to multiple medications.
    - Have frequent falls that could result in hospitalization or could compromise response to treatment.
    - Have a confounding painful condition that may interfere with assessment of the index joint, that is, knee. (Knee pain should be the predominant pain. Mild OA of the hands is allowed, for instance.)
    - Have a diagnosis of inflammatory arthritis (that is, rheumatoid arthritis) or an autoimmune disorder (excluding inactive Hashimoto’s thyroiditis).
    - Have received intrarticular hyaluronate or steroids, joint lavage, or other invasive therapies to the knee in the past 3 months.
    - Have had knee arthroscopy of the index knee within the past year or joint replacement of the index knee at anytime.
    - Have surgery planned during the trial for the index joint.
    - Has had a prior synovial fluid analysis showing a white blood cell (WBC) greater or equal to 2000 mm3 that is indicative of a diagnosis other than OA.
    - Are non-ambulatory or require the use of crutches or a walker.
    - Have a body mass index (BMI) over 40.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy measure for this study is the Brief Pain Inventory (BPI) average pain scores.
    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 Yes
    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 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA9
    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
    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 months11
    E.8.9.1In the Member State concerned days3
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days21
    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 state32
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 72
    F.4.2.2In the whole clinical trial 230
    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 Decision2007-04-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-05-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-05-04
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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