A Study of Duloxetine in Adolescents With Juvenile Primary Fibromyalgia Syndrome

Lilly

Status and phase: Completed; Phase 3

Conditions: Fibromyalgia

Treatments: Drug: Placebo; Drug: Duloxetine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01237587

14099

CTRI/2011/07/001866 (Registry Identifier)

F1J-MC-HMGW (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 184 patients

Sex: All

Ages: 13 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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• Previously completed or withdrawn after randomization from a study investigating duloxetine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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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184 participants in 2 patient groups, including a placebo group

Duloxetine

Experimental group

Description:

Blinded treatment period: 30mg or 60mg once daily for 13 weeks Open label extension: 30mg or 60mg Duloxetine once daily for 26 weeks Taper period: 30mg Duloxetine or placebo once daily for 1 week.

Treatment:

Drug: Duloxetine

Placebo

Placebo Comparator group

Description:

Blinded treatment period:Placebo once daily for 13 weeks Open label extension: 30mg or 60mg Duloxetine once daily for 26 weeks Taper period: 30mg Duloxetine or placebo once daily for 1 week.

Treatment:

Drug: Duloxetine

Drug: Placebo