Clinical trial NCT01237587: A Study of Duloxetine in Adolescents With Juvenile Primary Fibromyalgia Syndrome
Official title: Effect of Duloxetine 30/60 mg Once Daily Versus Placebo in Adolescents With Juvenile Primary Fibromyalgia Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Fibromyalgia
Keywords: Adolescents
Juvenile Primary Fibromyalgia Syndrome
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2010-11-09
Enrollment: 184
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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* Previously completed or withdrawn after randomization from a study investigating duloxetine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

Primary outcomes:
measure: Change From Baseline to 13 Week Endpoint in Brief Pain Inventory (BPI) Modified Short Form-adolescent Version 24 Hour Average Pain Severity Item
timeFrame: Baseline, 13 weeks
Secondary outcomes:
measure: Change From Baseline to 13 Week Endpoint in Brief Pain Inventory (BPI) Modified Short Form-Adolescent Version Severity and Interference Items
timeFrame: Baseline, 13 weeks
measure: Maintenance Effect in Acute Phase Responders on the Brief Pain Inventory (BPI) Modified Short Form-adolescent Version 24 Hour Average Pain Severity Item
timeFrame: Baseline (Extension Phase), 39 weeks
measure: Number of Participants With Greater Than or Equal to 30% Reduction From Baseline in BPI 24 Hour Average Pain Severity Score at 13 Weeks
timeFrame: 13 weeks
measure: Number of Participants With Greater Than or Equal to 50% Reduction From Baseline in BPI 24 Hour Average Pain Severity Score at 13 Weeks
timeFrame: 13 weeks
measure: Change From Baseline in Pediatric Pain Questionnaire (PPQ) Item Scores
timeFrame: Baseline, 13 weeks
measure: Change From Baseline in Clinical Global Impression (CGI) Severity: Overall Illness Score
timeFrame: Baseline, 13 weeks
measure: Change From Baseline in Clinical Global Impression (CGI) Severity: Mental Illness Score
timeFrame: Baseline, 13 weeks
measure: Change From Baseline in Functional Disability Inventory Child Form (FDI-Child)
timeFrame: Baseline, 13 weeks
measure: Change From Baseline in Functional Disability Inventory Parent Form (FDI-Parent)
timeFrame: Baseline, 13 weeks
measure: Change From Baseline in Children's Depression Inventory (CDI)
timeFrame: Baseline, 13 weeks
measure: Change From Baseline in Multidimensional Anxiety Scale for Children (MASC)
timeFrame: Baseline, 13 weeks
measure: Change From Baseline to 39 Week Endpoint in Brief Pain Inventory (BPI) Modified Short Form-adolescent Version Severity and Interference Items
timeFrame: Baseline (extension phase), 39 weeks
measure: Change From Baseline in Pediatric Pain Questionnaire (PPQ) Item Scores
timeFrame: Baseline (extension phase), 39 weeks
measure: Change From Baseline in Clinical Global Impression (CGI) Severity: Overall Illness Score
timeFrame: Baseline (extension phase), 39 weeks
measure: Change From Baseline in Clinical Global Impression (CGI) Severity: Mental Illness Score
timeFrame: Baseline (extension phase), 39 weeks
measure: Change From Baseline in Functional Disability Inventory Child Form (FDI-child)
timeFrame: Baseline (extension phase), 39 weeks
measure: Change From Baseline in Functional Disability Inventory Parent Form (FDI-parent)
timeFrame: Baseline (extension phase), 39 weeks
measure: Change From Baseline in Children's Depression Inventory (CDI)
timeFrame: Baseline (extension phase), 39 weeks
measure: Change From Baseline in Multidimensional Anxiety Scale for Children (MASC)
timeFrame: Baseline (extension phase), 39 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: NoesisPharma
state: Arizona
city: Loma Linda
country: United States
facility: Loma Linda University School of Medicine
state: California
city: National City
country: United States
facility: Synergy Clinical Research
state: California
city: Cromwell
country: United States
facility: Connecticut Clinical Trials LLC
state: Connecticut
city: Fairfield
country: United States
facility: Associated Neurologists of Southern Connecticut
state: Connecticut
city: West Palm Beach
country: United States
facility: Palm Beach Research Center
state: Florida
city: Smyrna
country: United States
facility: Institute for Behavioral Medicine
state: Georgia
city: Indianapolis
country: United States
facility: Riley Hosptial for Children
state: Indiana
city: Lexington
country: United States
facility: Kentucky Medical Research Center
state: Kentucky
city: Saint Louis
country: United States
facility: Mercy Health Research
state: Missouri
city: Nashua
country: United States
facility: Healthy Perspectives Innovative Mental Health Services, PL
state: New Hampshire
city: Albuquerque
country: United States
facility: Albuquerque Neurosciences
state: New Mexico
city: Mount Kisco
country: United States
facility: Bioscience Research, LLC
state: New York
city: Staten Island
country: United States
facility: Richmond Behavorial Associates
state: New York
city: Canton
country: United States
facility: Neurobehavioral Clinical Research
state: Ohio
city: Cincinnati
country: United States
facility: Univ of Cincinnati College of Medicine
state: Ohio
city: Middleburg Heights
country: United States
facility: North Star Research
state: Ohio
city: Oklahoma City
country: United States
facility: Neuropsychiatric Center
state: Oklahoma
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Philadelphia
country: United States
facility: CRI Lifetree
state: Pennsylvania
city: Kingsport
country: United States
facility: Holston Medical Group Clinical Research
state: Tennessee
city: San Antonio
country: United States
facility: Arthritis and Osteoporosis Center of South Texas
state: Texas
city: Salt Lake City
country: United States
facility: Bateman Horne Center of Excellence
state: Utah
city: Herndon
country: United States
facility: NeuroScience, Inc.
state: Virginia
city: Virginia Beach
country: United States
facility: Advanced Pain Management
state: Virginia
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
city: San Miguel De Tucuman
country: Argentina
facility: 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.
city: Chennai
country: India
facility: 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.
city: Hyderabad
country: India
facility: 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.
city: Mysore
country: India
facility: 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.
city: Raipur
country: India
facility: 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.
city: San Juan
country: Puerto Rico
facility: Centro de Investigaciones Clinicas
city: San Juan
country: Puerto Rico
facility: Centro Pediatrico Paseos
Study officials:
affiliation: Eli Lilly and Company
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)
role: STUDY_DIRECTOR
References:
citation: 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.