A Study of Duloxetine in Adolescents With Juvenile Primary Fibromyalgia Syndrome

• Register: ClinicalTrials.gov
• Last refreshed on: 20 May 2013
• Main ID: NCT01237587
• Date of registration: 08/11/2010
• Primary sponsor: Eli Lilly and Company
• Public title: A Study of Duloxetine in Adolescents With Juvenile Primary Fibromyalgia Syndrome
• Scientific title: Effect of Duloxetine 30/60 mg Once Daily Versus Placebo in Adolescents With Juvenile Primary Fibromyalgia Syndrome
• Date of first enrolment: February 2011
• Target sample size: 210
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01237587
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Countries of recruitment

Argentina, India, Puerto Rico, United States

Contacts

• Name: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

• Name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 : Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
• Affiliation: Eli Lilly and Company

Key inclusion & exclusion criteria

Inclusion Criteria

- 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

- Patient's parent/legal representative and patient judged to be reliable to keep all
appointments for clinical tests and procedures

- Patient's 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

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- Previously completed or withdrawn from this study or any duloxetine study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



Age minimum: 13 Years
Age maximum: 17 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Fibromyalgia

Intervention(s)

Drug: Duloxetine

Drug: Placebo

Primary Outcome(s)

Change from baseline to 13 week endpoint in Brief Pain Inventory (BPI) modified short form-adolescent version 24 hour average pain severity item [Time Frame: Baseline, 13 weeks]

Secondary Outcome(s)

Change from baseline in Children's Depression Inventory (CDI) [Time Frame: Baseline, 13 weeks ; Baseline (extension phase), 39 weeks]

Change from baseline in Clinical Global Impression (CGI) Severity: overall score and mental illness score [Time Frame: Baseline, 13 weeks ; Baseline (extension phase), 39 weeks]

Change from baseline in Functional Disability Inventory (FDI) child scale and rent scale [Time Frame: Baseline, 13 weeks ; Baseline (extension phase), 39 weeks]

Change from baseline in Multidimensional Anxiety Scale for Children (MASC) [Time Frame: Baseline, 13 weeks; Baseline (extension phase), 39 weeks]

Change from baseline in Pediatric Pain Questionnaire (PPQ) item scores [Time Frame: Baseline, 13 weeks ; Baseline (extension phase), 39 weeks]

Change from baseline to 13 week endpoint in Brief Pain Inventory (BPI) modified short form-adolescent version severity and interference items [Time Frame: Baseline, 13 weeks ; Baseline (extension phase), 39 weeks]

Maintenance effect in acute phase responders on the Brief Pain Inventory (BPI) modified short form-adolescent version 24 hour average pain severity item [Time Frame: Baseline (extension period), 39 weeks]

Proportion of patients with greater than or equal to 30% and 50% reduction in BPI 24 hour average pain severity score at 13 weeks [Time Frame: 13 weeks]

Secondary ID(s)

14099

CTRI/2011/07/001866

F1J-MC-HMGW

Source(s) of Monetary Support

Please refer to primary and secondary sponsors