A Study of Duloxetine in Adolescents With Juvenile Primary Fibromyalgia Syndrome
NCT ID: NCT01237587
Last Updated: 2019-09-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
184 participants
INTERVENTIONAL
2011-03-31
2017-11-28
Brief Summary
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This trial consists of two distinct study periods. A blinded treatment period of 13 weeks and an open label extension period of 26 weeks.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Duloxetine
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.
Duloxetine
Administered orally
Placebo
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.
Duloxetine
Administered orally
Placebo
Administered orally
Interventions
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Duloxetine
Administered orally
Placebo
Administered orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Previously completed or withdrawn after randomization from a study investigating duloxetine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
13 Years
17 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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NoesisPharma
Phoenix, Arizona, United States
Loma Linda University School of Medicine
Loma Linda, California, United States
Synergy Clinical Research
National City, California, United States
Connecticut Clinical Trials LLC
Cromwell, Connecticut, United States
Associated Neurologists of Southern Connecticut
Fairfield, Connecticut, United States
Palm Beach Research Center
West Palm Beach, Florida, United States
Institute for Behavioral Medicine
Smyrna, Georgia, United States
Riley Hosptial for Children
Indianapolis, Indiana, United States
Kentucky Medical Research Center
Lexington, Kentucky, United States
Mercy Health Research
St Louis, Missouri, United States
Healthy Perspectives Innovative Mental Health Services, PL
Nashua, New Hampshire, United States
Albuquerque Neurosciences
Albuquerque, New Mexico, United States
Bioscience Research, LLC
Mount Kisco, New York, United States
Richmond Behavorial Associates
Staten Island, New York, United States
Neurobehavioral Clinical Research
Canton, Ohio, United States
Univ of Cincinnati College of Medicine
Cincinnati, Ohio, United States
North Star Research
Middleburg Heights, Ohio, United States
Neuropsychiatric Center
Oklahoma City, Oklahoma, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
CRI Lifetree
Philadelphia, Pennsylvania, United States
Holston Medical Group Clinical Research
Kingsport, Tennessee, United States
Arthritis and Osteoporosis Center of South Texas
San Antonio, Texas, United States
Bateman Horne Center of Excellence
Salt Lake City, Utah, United States
NeuroScience, Inc.
Herndon, Virginia, United States
Advanced Pain Management
Virginia Beach, Virginia, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
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 Tucumán, , Argentina
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.
Chennai, , India
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.
Hyderabad, , India
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.
Mysore, , India
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.
Raipur, , India
Centro de Investigaciones Clinicas
San Juan, , Puerto Rico
Centro Pediatrico Paseos
San Juan, , Puerto Rico
Countries
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References
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Upadhyaya HP, Arnold LM, Alaka K, Qiao M, Williams D, Mehta R. Efficacy and safety of duloxetine versus placebo in adolescents with juvenile fibromyalgia: results from a randomized controlled trial. Pediatr Rheumatol Online J. 2019 May 28;17(1):27. doi: 10.1186/s12969-019-0325-6.
Provided Documents
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Document Type: Study Protocol: Protocol
Document Type: Study Protocol: Protocol Amendment (a)
Document Type: Statistical Analysis Plan
Document Type: Study Protocol: Protocol Amendment (b)
Related Links
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Click here for more information about this study: A Study of Duloxetine in Adolescents With Juvenile Primary Fibromyalgia Syndrome
Other Identifiers
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F1J-MC-HMGW
Identifier Type: OTHER
Identifier Source: secondary_id
CTRI/2011/07/001866
Identifier Type: REGISTRY
Identifier Source: secondary_id
14099
Identifier Type: -
Identifier Source: org_study_id
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