A Study of Duloxetine in Adolescents With Juvenile Primary Fibromyalgia Syndrome
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Intervention: Duloxetine; Placebo
Intervention description: Administered orally; Administered orally
Intervention MeSH terms: Duloxetine Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 184.0
Sex: All
Minimum age: 13 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Adolescents; Juvenile Primary Fibromyalgia Syndrome

Summary:

      The purpose of this study is to determine whether duloxetine is safe and effective in the
      treatment of adolescents with Juvenile Primary Fibromyalgia Syndrome (JPFS).

      This trial consists of two distinct study periods. A blinded treatment period of 13 weeks and
      an open label extension period of 26 weeks.
    

Eligibility criteria:

        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

        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          -  Previously completed or withdrawn after randomization from a study investigating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