A Study of Duloxetine in Adolescents With Juvenile Primary Fibromyalgia Syndrome
- Conditions
- Health Condition 1: null- Fibromyalgia
- Registration Number
- CTRI/2011/07/001866
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 210
Meet criteria for primary JPFS
-Have a score of greater than or equal to 4 on BPI average pain severity (Item 3) during screening
-Female patients must have a negative serum pregnancy test during screening
-Patients parent/legal representative and patient judged to be reliable to keep all appointments for clinical tests and procedures
-Patients parent/legal representative and patient must have a degree of understanding such that they can communicate intelligently
-Patients must be capable of swallowing investigational product whole
-Patients must have venous access sufficient to allow blood sampling and be compliant with blood draws
-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-Previously completed or withdrawn from this study or any duloxetine study
-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 or previous diagnosis of rheumatoid arthritis, inflammatory arthritis, or infectious arthritis, or an autoimmune disease (for example, systemic lupus erythematosus)
-Have a 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 kg at screening
-Changed the type or intensity of psychotherapy within 3 months prior to 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 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
-Initiated or discontinued hormone therapy within the previous 3 months
-Female patients who are either pregnant, nursing or have recently given birth
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from baseline to 13 week endpoint in Brief Pain Inventory (BPI) modified short form-adolescent version 24 hour average pain severity itemTimepoint: Baseline, 13 weeks
- Secondary Outcome Measures
Name Time Method