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    Summary
    EudraCT Number:2018-001615-78
    Sponsor's Protocol Code Number:F1J-MC-HMGW
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2018-05-02
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2018-001615-78
    A.3Full title of the trial
    Effect of Duloxetine 30/60 mg Once Daily Versus Placebo in Adolescents With Juvenile Primary Fibromyalgia Syndrome
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to determine whether duloxetine is safe and effective in the treatment of adolescents with Juvenile Primary Fibromyalgia Syndrome (JPFS).
    A.4.1Sponsor's protocol code numberF1J-MC-HMGW
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    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 Capsule
    D.3.4.1Specific paediatric formulation No
    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 116539-59-4
    D.3.9.4EV Substance CodeSUB06424MIG
    D.3.10 Strength
    D.3.10.1Concentration unit MBq/mg megabecquerel(s)/milligram
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Juvenile Primary Fibromyalgia Syndrome
    E.1.1.1Medical condition in easily understood language
    Fibromyalgia
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of duloxetine 30/60 mg once daily
    (QD) compared with placebo on the reduction of average pain severity as measured by the Brief Pain Inventory (BPI)
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of duloxetine 30/60 mg QD in the treatment of adolescents with
    JPFS during a 13-week, double-blind treatment phase, based on the improvement of the
    following measures:
    o Brief Pain Inventory (BPI) Modified Short Form: Adolescent Version severity
    (worst pain, least pain, pain right now) and interference.
    o Response to treatment, as defined by a 30% and 50% reduction in the BPI average
    pain severity.
    o Pediatric Pain Questionnaire (PPQ) pain right now, worst pain and average pain
    items.
    o Clinical Global Impression of Severity for Overall Illness (CGI-S: Overall
    Illness) scale.
    o Clinical Global Impression of Severity for Mental Illness (CGI-S: Mental Illness)
    scale.
    o Functional Disability Inventory - child version scale (FDI-child).
    o Functional Disability Inventory - parent version scale (FDI-parent).
    o Children's Depression Inventory (CDI).
    o Multidimensional Anxiety Scale for Children (MASC).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Meet criteria for primary JPFS
    •Have a score of greater than or equal to 4 on Brief Pain Inventory (BPI) average pain severity (Item 3) during screening
    •Female participants must have a negative serum pregnancy test during screening
    •Participant's parent/legal representative and participant judged to be reliable to keep all appointments for clinical tests and procedures
    •Participant's parent/legal representative and participant must have a degree of understanding such that they can communicate intelligently
    •Participants must be capable of swallowing investigational product whole
    •Participants must have venous access sufficient to allow blood sampling and be compliant with blood draws
    E.4Principal exclusion criteria
    •Currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational drug or device or off-label use of a drug or device or concurrently enrolled in any other type of medical research
    •Previously completed or withdrawn after randomization from a study investigating duloxetine
    •Known hypersensitivity to duloxetine or any of the inactive ingredients, or have frequent or severe allergic reactions to multiple medications
    •Treated with duloxetine within the last 6 months. Will not likely benefit from duloxetine treatment, in the opinion of the investigator or have had prior nonresponse or inadequate tolerance to duloxetine
    •Pain symptoms related to traumatic injury, past surgery, structural bone or joint disease or regional pain syndrome that will interfere with interpretation of outcome measures
    •Currently have evidence of rheumatologic disorder or have a current diagnosis of rheumatoid arthritis, inflammatory arthritis, or infectious arthritis, or an autoimmune disease (for example, systemic lupus erythematosus)
    •Have a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) Axis I condition, currently or within the past year, except major depressive disorder (MDD) and/or generalized anxiety disorder (GAD), adjustment disorder or specific phobias with primary investigator approval
    •Have a current secondary DSM-IV Axis I condition of attention-deficit/hyperactivity disorder that requires pharmacologic treatment
    •Lifetime DSM-IV Axis I diagnosis of psychosis, bipolar disorder, or schizoaffective disorder
    •DSM-IV Axis II disorder which would interfere with protocol compliance
    •History of substance abuse or dependence within the 6 months
    •Positive urine drug screen for any substances of abuse or excluded medication
    •Family history of 1 or more first-degree relatives with diagnosed bipolar I disorder
    •Significant suicide attempt within 1 year of screening or are currently at suicidal risk in the opinion of the investigator
    •Weight less than 20 kilogram (kg) at screening
    •History of seizure disorder (other than febrile seizures)
    •Taking any excluded medications that cannot be discontinued at screening
    •Fluoxetine within 30 days prior to completion of screening
    •Monoamine oxidase inhibitor (MAOI) within 14 days of screening; or the potential need to use an MAOI during the study or within 5 days of discontinuation of investigational product
    •Abnormal thyroid-stimulating hormone (TSH) concentrations
    •Uncontrolled narrow-angle glaucoma
    •Acute liver injury (such as hepatitis) or severe cirrhosis (Child-Pugh Class C)
    •Serious or unstable medical illness
    •Female participants who are either pregnant, nursing or have recently given birth
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline to 13 week endpoint in Brief Pain Inventory (BPI) modified short form-adolescent version 24 hour average pain severity item
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline, 13 weeks
    E.5.2Secondary end point(s)
    1.Change from baseline to 13 week endpoint in Brief Pain Inventory (BPI) modified short form-adolescent version severity and interference items
    2.Maintenance effect in acute phase responders on the Brief Pain Inventory (BPI) modified short form-adolescent version 24 hour average pain severity item
    3.Proportion of patients with greater than or equal to 30% and 50% reduction in BPI 24 hour average pain severity score at 13 weeks
    4.Change from baseline in Pediatric Pain Questionnaire (PPQ) item scores
    5.Change from baseline in Clinical Global Impression (CGI) Severity: overall score and mental illness score
    6.Change from baseline in Functional Disability Inventory (FDI) child scale and rent scale
    7.Change from baseline in Children's Depression Inventory (CDI)
    8.Change from baseline in Multidimensional Anxiety Scale for Children (MASC
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline, 13 weeks ; Baseline (extension phase), 39 weeks
    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 No
    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 No
    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.8.2.4Number of treatment arms in the trial2
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    Argentina
    India
    United States
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 184
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 184
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 180
    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)
    None
    G. Investigator Networks to be involved in the Trial
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: United States
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