A Study of Duloxetine in Adolescents With Juvenile Primary Fibromyalgia Syndrome



Status:Completed
Conditions:Fibromyalgia, Pain
Therapuetic Areas:Musculoskeletal, Rheumatology
Healthy:No
Age Range:13 - 17
Updated:8/16/2018
Start Date:March 2011
End Date:November 28, 2017

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Effect of Duloxetine 30/60 mg Once Daily Versus Placebo in Adolescents With Juvenile Primary Fibromyalgia Syndrome

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.


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- Previously completed or withdrawn after randomization from a study investigating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
We found this trial at
27
sites
Middleburg Heights, Ohio 44130
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Middleburg Heights, OH
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1897 Palm Beach Lakes Boulevard
West Palm Beach, Florida 33409
561-689-0606
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West Palm Beach, FL
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Albuquerque, New Mexico 87109
Principal Investigator: Glenn Dempsey
Phone: 505-848-3773
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Albuquerque, NM
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Bellevue, Washington 98007
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Bellevue, WA
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Canton, OH
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Cincinnati, Ohio 45267
Principal Investigator: Lesley Arnold
Phone: 513-558-7104
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Cincinnati, OH
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Cromwell, Connecticut 06416
Principal Investigator: C. Brendan Montano
Phone: 860-632-0144
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Cromwell, CT
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Duncansville, Pennsylvania 16635
Principal Investigator: Alan Kivitz
Phone: 814-693-0300
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Duncansville, PA
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Fairfield, CT
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Herndon, Virginia 20170
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Herndon, VA
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Indianapolis, Indiana 46202
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Indianapolis, IN
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Kingsport, Tennessee 37660
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Kingsport, TN
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Lexington, Kentucky 40504
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Lexington, KY
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Loma Linda, California 92354
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Loma Linda, CA
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Mount Kisco, New York 10549
Principal Investigator: David Krakow
Phone: 914-385-0200
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Mount Kisco, NY
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Nashua, New Hampshire 03060
Principal Investigator: Hisham Hafez
Phone: 603-758-6810
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Nashua, NH
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National City, California 91950
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National City, CA
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Oklahoma City, Oklahoma 73109
Principal Investigator: Siavash Nael
Phone: 405-634-5529
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Oklahoma City, OK
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Philadelphia, Pennsylvania 19139
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Philadelphia, PA
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Phoenix, Arizona 85032
Principal Investigator: Lee Kelley
Phone: 602-795-1834
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Phoenix, AZ
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Saint Louis, Missouri 63141
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Saint Louis, MO
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Salt Lake City, Utah 84102
Principal Investigator: Lucinda Bateman
Phone: 801-532-8311
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Salt Lake City, UT
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San Antonio, TX
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San Miguel de Tucuman,
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Smyrna, Georgia 30080
Principal Investigator: Ashraf Attalla
Phone: 770-319-8013
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Smyrna, GA
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Staten Island, New York 10312
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Staten Island, NY
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Virginia Beach, Virginia 23454
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Virginia Beach, VA
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