A Study of Duloxetine in Adolescents With Juvenile Primary Fibromyalgia Syndrome
Effect of Duloxetine 30/60 mg Once Daily Versus Placebo in Adolescents With Juvenile Primary Fibromyalgia Syndrome
3 other identifiers
interventional
184
4 countries
33
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Mar 2011
Longer than P75 for phase_3
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 8, 2010
CompletedFirst Posted
Study publicly available on registry
November 9, 2010
CompletedStudy Start
First participant enrolled
March 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 28, 2017
CompletedResults Posted
Study results publicly available
August 14, 2018
CompletedSeptember 20, 2019
September 1, 2019
6.3 years
November 8, 2010
May 25, 2018
September 5, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory (BPI) Modified Short Form-adolescent Version 24 Hour Average Pain Severity Item
Brief Pain Inventory (BPI) modified short form is a self-reported scale that measures the severity of pain and the interference of pain on function, Severity scores range from 0 (no pain) to 10 (pain as bad as you can imagine). Severity of pain is measured based on the average pain experienced over the past 24-hours. Mixed Model Repeated Measure (MMRM) model with terms for treatment, pooled investigator, visit, baseline, treatment by visit, and baseline by visit was used to produce Least Square (LS) means.
Baseline, 13 weeks
Secondary Outcomes (19)
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory (BPI) Modified Short Form-Adolescent Version Severity and Interference Items
Baseline, 13 weeks
Maintenance Effect in Acute Phase Responders on the Brief Pain Inventory (BPI) Modified Short Form-adolescent Version 24 Hour Average Pain Severity Item
Baseline (Extension Phase), 39 weeks
Number of Participants With Greater Than or Equal to 30% Reduction From Baseline in BPI 24 Hour Average Pain Severity Score at 13 Weeks
13 weeks
Number of Participants With Greater Than or Equal to 50% Reduction From Baseline in BPI 24 Hour Average Pain Severity Score at 13 Weeks
13 weeks
Change From Baseline in Pediatric Pain Questionnaire (PPQ) Item Scores
Baseline, 13 weeks
- +14 more secondary outcomes
Study Arms (2)
Duloxetine
EXPERIMENTALBlinded 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.
Placebo
PLACEBO COMPARATORBlinded 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (33)
NoesisPharma
Phoenix, Arizona, 85032, United States
Loma Linda University School of Medicine
Loma Linda, California, 92354, United States
Synergy Clinical Research
National City, California, 91950, United States
Connecticut Clinical Trials LLC
Cromwell, Connecticut, 06416, United States
Associated Neurologists of Southern Connecticut
Fairfield, Connecticut, 06824, United States
Palm Beach Research Center
West Palm Beach, Florida, 33409, United States
Institute for Behavioral Medicine
Smyrna, Georgia, 30080, United States
Riley Hosptial for Children
Indianapolis, Indiana, 46202, United States
Kentucky Medical Research Center
Lexington, Kentucky, 40504, United States
Mercy Health Research
St Louis, Missouri, 63141, United States
Healthy Perspectives Innovative Mental Health Services, PL
Nashua, New Hampshire, 03060, United States
Albuquerque Neurosciences
Albuquerque, New Mexico, 87109, United States
Bioscience Research, LLC
Mount Kisco, New York, 10549, United States
Richmond Behavorial Associates
Staten Island, New York, 10312, United States
Neurobehavioral Clinical Research
Canton, Ohio, 44718, United States
Univ of Cincinnati College of Medicine
Cincinnati, Ohio, 45219, United States
North Star Research
Middleburg Heights, Ohio, 44130, United States
Neuropsychiatric Center
Oklahoma City, Oklahoma, 73109, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
CRI Lifetree
Philadelphia, Pennsylvania, 19139, United States
Holston Medical Group Clinical Research
Kingsport, Tennessee, 37660, United States
Arthritis and Osteoporosis Center of South Texas
San Antonio, Texas, 78232, United States
Bateman Horne Center of Excellence
Salt Lake City, Utah, 84102, United States
NeuroScience, Inc.
Herndon, Virginia, 20170-2613, United States
Advanced Pain Management
Virginia Beach, Virginia, 23505, United States
Northwest Clinical Research Center
Bellevue, Washington, 98007-4209, 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, T4000AXL, 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, 600003, 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, 500034, 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, 570004, 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, 492001, India
Centro de Investigaciones Clinicas
San Juan, 00912, Puerto Rico
Centro Pediatrico Paseos
San Juan, 00926, Puerto Rico
Related Publications (1)
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.
PMID: 31138224DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- STUDY DIRECTOR
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)
Eli Lilly and Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 8, 2010
First Posted
November 9, 2010
Study Start
March 1, 2011
Primary Completion
May 31, 2017
Study Completion
November 28, 2017
Last Updated
September 20, 2019
Results First Posted
August 14, 2018
Record last verified: 2019-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.