A Study of Duloxetine in Adolescents With Juvenile Primary Fibromyalgia Syndrome
Information source: Eli Lilly and Company
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Fibromyalgia
Intervention: Duloxetine (Drug); Placebo (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Eli Lilly and Company Official(s) and/or principal investigator(s): 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), Study Director, Affiliation: Eli Lilly and Company
Overall contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or, Phone: 1-317-615-4559
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.
Clinical Details
Official title: Effect of Duloxetine 30/60 mg Once Daily Versus Placebo in Adolescents With Juvenile Primary Fibromyalgia Syndrome
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Change from baseline to 13 week endpoint in Brief Pain Inventory (BPI) modified short form-adolescent version 24 hour average pain severity item
Secondary outcome: Change from baseline to 13 week endpoint in Brief Pain Inventory (BPI) modified short form-adolescent version severity and interference itemsMaintenance effect in acute phase responders on the Brief Pain Inventory (BPI) modified short form-adolescent version 24 hour average pain severity item Proportion of patients with greater than or equal to 30% and 50% reduction in BPI 24 hour average pain severity score at 13 weeks Change from baseline in Pediatric Pain Questionnaire (PPQ) item scores Change from baseline in Clinical Global Impression (CGI) Severity: overall score and mental illness score Change from baseline in Functional Disability Inventory (FDI) child scale and rent scale Change from baseline in Children's Depression Inventory (CDI) Change from baseline in Multidimensional Anxiety Scale for Children (MASC)
Eligibility
Minimum age: 13 Years.
Maximum age: 17 Years.
Gender(s): Both.
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
Locations and Contacts
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or, Phone: 1-317-615-4559
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Buenos Aires C1270AAN, Argentina; Recruiting Eli Lilly and Company
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., San Miguel De Tucuman T4000AXL, Argentina; Recruiting Eli Lilly and Company
Centro de Investigaciones Clinicas, San Juan 00912, Puerto Rico; Recruiting Phone: 7879999453 Annette Lopez, Principal Investigator
GCM Medical Group PSC, San Juan 00909, Puerto Rico; Not yet recruiting Phone: 787-726-8396 Gregorio Cortes-Maisonet, Principal Investigator
NoesisPharma, Phoenix, Arizona 85032, United States; Recruiting Phone: 602-795-1834 Lee Kelley, Principal Investigator
Connecticut Clinical Trials LLC, Cromwell, Connecticut 06416, United States; Recruiting Phone: 860-632-0144 C. Brendan Montano, Principal Investigator
Institute for Behavioral Medicine, Smyrna, Georgia 30080, United States; Recruiting Phone: 770-319-8013 Ashraf Attalla, Principal Investigator
Healthy Perspectives Innovative Mental Health Services, PL, Nashua, New Hampshire 03060, United States; Recruiting Phone: 603-758-6810 Hisham Hafez, Principal Investigator
Albuquerque Neurosciences, Albuquerque, New Mexico 87109, United States; Recruiting Phone: 505-848-3773 Glenn Dempsey, Principal Investigator
Bioscience Research, LLC, Mount Kisco, New York 10549, United States; Recruiting Phone: 914-385-0200 David Krakow, Principal Investigator
Univ of Cincinnati College of Medicine, Cincinnati, Ohio 45219, United States; Recruiting Phone: 513-558-7104 Lesley Arnold, Principal Investigator
Neuropsychiatric Center, Oklahoma City, Oklahoma 73109, United States; Recruiting Phone: 405-634-5529 Siavash Nael, Principal Investigator
Altoona Center for Clinical Research, Duncansville, Pennsylvania 16635, United States; Recruiting Phone: 814-693-0300 Alan Kivitz, Principal Investigator
Arthritis and Osteoporosis Center of South Texas, San Antonio, Texas 78232, United States; Completed
The Fatigue Consultation Clinic, Salt Lake City, Utah 84102, United States; Recruiting Phone: 801-532-8311 Lucinda Bateman, Principal Investigator
Additional Information
Starting date: March 2011
Last updated: August 19, 2015
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