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    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2009-014605-14
    Sponsor's Protocol Code Number:F1J-US-HMGR
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-11-05
    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 ConcernedFrance - ANSM
    A.2EudraCT number2009-014605-14
    A.3Full title of the trial
    A Phase 4, 8-Week, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy of Duloxetine 60 mg Once Daily in Outpatients with Major Depressive Disorder and Associated Painful Physical Symptoms
    A.3.2Name or abbreviated title of the trial where available
    Etude HMGR
    A.4.1Sponsor's protocol code numberF1J-US-HMGR
    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 60 mg hard gastro-resistant capsules
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly and Nederlend B.V.
    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 HYDROCHLORIDE
    D.3.9.1CAS number 136434-34-9
    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.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 30 mg hard gastro-resistant capsules
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly and Nederlend B.V.
    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 HYDROCHLORIDE
    D.3.9.1CAS number 136434-34-9
    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.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
    Major depressive disorder
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10025453
    E.1.2Term Major depressive disorder NOS
    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 of this study is to test the hypothesis that duloxetine given 60 mg (30 mg for first week) once daily (QD), orally, for 8 weeks is superior to placebo QD, orally, for 8 weeks in the treatment of adult outpatients with MDD and associated painful physical symptoms.
    E.2.2Secondary objectives of the trial
    • To evaluate duloxetine 60 mg QD versus placebo on the MADRS – gated:
    – mean change from baseline to 8-week endpoint in MADRS Total Score
    – remission rate at 8-week endpoint (MADRS Total Score less than or equal to 12)
    • To evaluate duloxetine 60 mg QD versus placebo on the mean change from baseline to 8-week endpoint on the SDS Total Score and Item Scores.
    • To evaluate duloxetine 60 mg QD versus placebo on the mean change from baseline to 8-week endpoint on the BPI-SF Severity and Interference Scores.
    • To evaluate duloxetine 60 mg QD versus placebo on the 8-week mean endpoint of the PGI-I scale.
    • To assess safety of duloxetine 60 mg QD versus placebo during an 8-week trial with reasons and rates for early discontinuations, TEAEs, vital signs, laboratory measurements, and suicide risk and suicide-related events (behavior and/or ideation) as examined by the C-SSRS.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    [1] Meet criteria for MDD as defined by DSM-IV-TR and confirmed by the Mini International Neuropsychiatric Interview (MINI).
    [2] Male or female outpatients aged 18 years or older.
    [3] MADRS total score greater than or equal to 20.
    [4] At least 1 previous episode of depression in medical history.
    [5] Painful physical symptoms with a score greater than or equal to 3 on the BPI-SF average pain question.
    [6] Clinical Global Impression of Severity (CGI-S) score greater than or equal to 4.
    [7] Written informed consent prior to any study procedure in accordance with Good Clinical Practice (GCP) and local regulatory requirements.
    [8] Level of understanding sufficient to provide informed consent, complete protocol required self-rated assessments, and communicate intelligibly with the investigators, study coordinator, and site personnel.
    [9] Judged by the investigator to be reliable and agree to keep all appointments for clinic visits, tests, and procedures required by the protocol, and able to swallow all required medication without opening or crushing.
    [10] Agree to not participate in any other research trial or study while enrolled in this study.
    E.4Principal exclusion criteria
    [1] Are investigator site personnel directly affiliated with this study and/or their immediate families.
    [2] Are Lilly employees.
    [3] Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug or device (other than the study drug used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
    [4] Have previously completed or withdrawn from this study or any other study investigating duloxetine.
    [5] Women of child-bearing potential (not surgically sterilized and between menarche and 1 year postmenopausal) who are not using a medically accepted means of contraception when engaging in sexual intercourse during the study and 1 month following the last dose of study drug. Note: Women who are pregnant or breastfeeding may not participate in the study.
    [6] Have any current (within past 6 months) DSM-IV-TR primary Axis I diagnosis other than MDD, including, but not limited to, any anxiety disorder, dysthymia, or eating disorders as determined by subject history or by diagnosis using specific modules of the MINI.
    [7] Have a history of alcohol abuse or dependence within 1 year immediately prior to screening.
    [8] Have any prior history of bipolar disorder, psychosis, or schizophrenia.
    [9] Presence of an Axis II disorder that, in the judgment of the investigator, would interfere with study compliance.
    [10] Lack of response of any (lifetime of subject) episode of major depression to 2 or more adequate courses of antidepressant therapy at a clinically appropriate dose for a minimum of 4 weeks or, in the judgment of the investigator, the subject meets criteria for treatment-resistant depression.
    [11] Have previously received treatment of MDD or GAD with an adequate trial of duloxetine and did not respond or could not tolerate duloxetine.
    [12] Diagnosis with acute liver injury (for example, hepatitis) or severe cirrhosis (Child-Pugh Class C).
    [13] Uncontrolled narrow-angle glaucoma.
    [14] Positive urine drug screen for any substance of abuse.
    [15] Have a serious medical illness or clinically significant laboratory abnormality that is not stabilized or is anticipated to require intervention, hospitalization, or use of an excluded medication during the study, in the opinion of the investigator.
    [16] Have a history of substance abuse or dependence within 1 year immediately prior to screening (drug categories defined in the DSM-IV-TR), excluding nicotine and caffeine.
    [17] History of serious suicide attempt or subject judged clinically to be at serious suicidal risk in the opinion of the investigator.
    [18] Subjects requiring continuous use of analgesics (>step 2 WHO definition) because of chronic pain (>6 months).
    [19] Subjects with pain of a known origin.
    [20] Subjects meeting the American College of Rheumatology diagnostic criteria for fibromyalgia as defined by the presence of chronic widespread pain and tenderness in all 4 body quadrants (above and below waist, and on the left and right sides of the body) for 3 months or more and at least 11 of 18 tender point sites (Wolfe et al. 1990).
    [21] Subjects experiencing 1 or more migraine headache per week.
    [22] Have had electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), or vagus nerve stimulation (VNS) within 1 year prior to screening.
    [23] Initiating, changing, or stopping psychotherapy within 6 weeks prior to screening or initiating, changing, or stopping psychotherapy at any time during the study.
    [24] Initiating, changing, or stopping non-pharmacologic or alternative therapies (for example, acupuncture, biofeedback, or massage) for painful physical symptoms at any time during the study.
    [25] Are taking any excluded medications.
    [26] Treatment with a MAOI within 14 days prior to enrollment or have the potential need to use an MAOI during the study or within 5 days of discontinuation of study drug.
    [27] Frequent and/or severe allergic reactions with multiple medications. Known hypersensitivity to duloxetine or any of the inactive ingredients.
    [28] Abnormal thyroid stimulating hormone (TSH) concentration (that is, outside the reference range of the performing laboratory). Note: Subjects diagnosed with hyperthyroidism or hypothyroidism who have been treated on a stable dose of thyroid supplement for at least the past 3 months prior to screening, have a medically appropriate TSH concentration, and are clinically euthyroid are allowed.
    [29] Have epilepsy or history of seizure disorder or received treatment with anticonvulsant medication for epilepsy or seizures.
    E.5 End points
    E.5.1Primary end point(s)
    The primary end point for this study is the mean change from baseline in BPI-SF average pain question score over 8 weeks of treatment.
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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 years1
    E.8.9.1In the Member State concerned months0
    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 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 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 state115
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 240
    F.4.2.2In the whole clinical trial 520
    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)
    Return to standard of care.
    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 Decision2009-11-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-12-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-10-26
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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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