A Study of Duloxetine in Adolescents With Juvenile Primary Fibromyalgia Syndrome

Phase 3

Completed

Conditions: Fibromyalgia

Interventions: Drug: Duloxetine
Drug: Placebo

Registration Number: NCT01237587

Lead Sponsor: Eli Lilly and Company

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 184

Inclusion Criteria

Not provided

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Previously completed or withdrawn after randomization from a study investigating duloxetine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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	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.
Placebo	Duloxetine	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	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.

Primary Outcome Measures

Name	Time	Method
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory (BPI) Modified Short Form-adolescent Version 24 Hour Average Pain Severity Item	Baseline, 13 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory (BPI) Modified Short Form-Adolescent Version Severity and Interference Items	Baseline, 13 weeks	The Brief Pain Inventory (BPI) - Modified Short Form Adolescent Version is a self-reported scale that measures the severity of pain and the interference of pain on function. The Severity scores range from 0 (no pain) to 10 (pain as bad as you can imagine).There are 4 questions assessing the severity for worst pain, least pain, average pain in the past 24 hours (which is the primary efficacy measure), and the pain right now. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). There are 7 original questions assessing the interference of pain in the past 24 hours on the following: general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. The BPI: Adolescent Version added an eighth interference question to assess interference of pain on school work. MMRM model with terms for treatment, pooled investigator, visit, baseline, treatment by visit, and baseline by visit was used to produce LS means.
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	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. Acute phase responders: Participants with ≥30% pain reduction from baseline on the BPI average pain severity measure at the last non-missing assessment in acute phase.
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	Brief Pain Inventory (BPI) modified short form is a self-reported scale that measures the severity of pain and 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. Percent reduction of BPI 24 hour average pain from baseline to last observation carried forward (LOCF).
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	Brief Pain Inventory (BPI) modified short form is a self-reported scale that measures the severity of pain and 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. Percent reduction of BPI 24 hour average pain from baseline to last observation carried forward (LOCF).
Change From Baseline in Clinical Global Impression (CGI) Severity: Overall Illness Score	Baseline (extension phase), 39 weeks	Clinical Global Impression of Severity: Overall Illness (CGI-S: Overall Illness) scale evaluates the severity of the overall illness of JPFS, including all relevant, associated symptoms. The scoring ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). The scoring is based on observed and reported symptoms and behaviors over the past 7 days that are ongoing at the time of the Study Visit. Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS mean with terms for pooled investigator and baseline value.
Change From Baseline in Clinical Global Impression (CGI) Severity: Mental Illness Score	Baseline (extension phase), 39 weeks	Clinical Global Impression of Severity: Mental Illness (CGI-S: Mental Illness) scale evaluates the severity of any diagnosed, comorbid Axis I/II condition. The scoring ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Participants without a diagnosed Axis I/II condition should receive a score of 1 (normal, not at all ill). Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS mean with terms for pooled investigator and baseline value.
Change From Baseline in Functional Disability Inventory Child Form (FDI-child)	Baseline (extension phase), 39 weeks	Functional Disability Inventory-child form (FDI-child) is a self-reported scale to assess the physical trouble or difficulty the child has doing regular activities. This scale contains 15 items. Each item is scored on a 0- to-4-point scale (0 = no trouble, 1 = a little trouble, 2 = some trouble, 3 = a lot of trouble, 4 = impossible).The total score ranges from 0 to 60. The higher the score, the more physical trouble or difficulty the child has doing regular activities. Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for pooled investigator and baseline value.
Change From Baseline in Pediatric Pain Questionnaire (PPQ) Item Scores	Baseline (extension phase), 39 weeks	Pediatric Pain Questionnaire (PPQ) is a self-reported scale that measures the severity for "pain now," worst pain, and average pain in the past week with 100 mm VAS (Visual Analog Scale). The severity scores range from 0 (no hurting, no discomfort, no pain) to 100 (hurting a whole lot, very uncomfortable, severe pain). Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for pooled investigator and baseline value.
Change From Baseline to 39 Week Endpoint in Brief Pain Inventory (BPI) Modified Short Form-adolescent Version Severity and Interference Items	Baseline (extension phase), 39 weeks	The BPI - Modified Short Form Adolescent Version is a self-reported scale that measures the severity of pain and the interference of pain on function. The Severity scores range from 0 (no pain) to 10 (pain as bad as you can imagine).There are 4 questions assessing the severity for worst pain, least pain, average pain in the past 24 hours (which is the primary efficacy measure), and the pain right now. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). There are 7 original questions assessing the interference of pain in the past 24 hours on the following: general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. The BPI: Adolescent Version added an eighth interference question to assess interference of pain on school work. Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for pooled investigator and baseline value.
Change From Baseline in Functional Disability Inventory Child Form (FDI-Child)	Baseline, 13 weeks	Functional Disability Inventory-child form (FDI-child) is a self-reported scale to assess the physical trouble or difficulty the child has doing regular activities. This scale contains 15 items. Each item is scored on a 0- to-4-point scale (0 = no trouble, 1 = a little trouble, 2 = some trouble, 3 = a lot of trouble, 4 = impossible).The total score ranges from 0 to 60. The higher the score, the more physical trouble or difficulty the child has doing regular activities. Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for treatment, pooled investigator and baseline value.
Change From Baseline in Functional Disability Inventory Parent Form (FDI-Parent)	Baseline, 13 weeks	Functional Disability Inventory-parent form (FDI-parent) contains the same items as FDI-child, but is reported by parent/legal representative. The total score range from 0 to 60. The higher the score, the more physical trouble or difficulty the child has doing regular activities. Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for treatment, pooled investigator and baseline value.
Change From Baseline in Children's Depression Inventory (CDI)	Baseline (extension phase), 39 weeks	Children's Depression Inventory (CDI) is modeled after the Beck Depression Inventory and is a 27-item self-reported, symptom-oriented scale designed for school-aged children and adolescents. Each item is scored on a 0-to-2-point scale (in increasing severity) and thus the total score ranges from 0 to 54. The higher the score, the more severe the depression. Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for pooled investigator and baseline value.
Change From Baseline in Multidimensional Anxiety Scale for Children (MASC)	Baseline (extension phase), 39 weeks	Multidimensional Anxiety Scale for Children (MASC) is a self-reported scale developed to assess anxiety in children and adolescents. The MASC consists of 39 items that comprise 4 factors with each item scored on a 0-to-3-point scale (0-never true about me, 1-rarely true about me, 2- sometimes true about me, 3-often true about me). : 1) physical symptoms (tense/restless and somatic/autonomic)-12 items with score range 0 to 36; 2) social anxiety (humiliation/rejection and public performance fears)-9 items with score range of 0 to 27; 3) harm avoidance (perfectionism and anxious coping)-9 items with score range of 0 to 27; and 4) separation anxiety-9 items with score range of 0 to 27. Total score ranges from 0 to 117. The higher the total score, the more severe the anxiety.ANCOVA model with last observation carried forward (LOCF) was used to produce LS means with terms for pooled investigator and baseline value.
Change From Baseline in Functional Disability Inventory Parent Form (FDI-parent)	Baseline (extension phase), 39 weeks	Functional Disability Inventory-parent form (FDI-parent) contains the same items as FDI-child, but is reported by parent/legal representative. The total score range from 0 to 60. The higher the score, the more physical trouble or difficulty the child has doing regular activities. Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for pooled investigator and baseline value.

Trial Locations

Locations (29): Centro de Investigaciones Clinicas
🇵🇷
San Juan, Puerto Rico
Synergy Clinical Research
🇺🇸
National City, California, United States
Northwest Clinical Research Center
🇺🇸
Bellevue, Washington, United States
Centro Pediatrico Paseos
🇵🇷
San Juan, Puerto Rico
Neurobehavioral Clinical Research
🇺🇸
Canton, Ohio, United States
CRI Lifetree
🇺🇸
Philadelphia, Pennsylvania, United States
Loma Linda University School of Medicine
🇺🇸
Loma Linda, California, United States
Connecticut Clinical Trials LLC
🇺🇸
Cromwell, Connecticut, United States
Holston Medical Group Clinical Research
🇺🇸
Kingsport, Tennessee, United States
Palm Beach Research Center
🇺🇸
West Palm Beach, Florida, United States
Riley Hosptial for Children
🇺🇸
Indianapolis, Indiana, United States
Advanced Pain Management
🇺🇸
Virginia Beach, Virginia, United States
NoesisPharma
🇺🇸
Phoenix, Arizona, United States
Univ of Cincinnati College of Medicine
🇺🇸
Cincinnati, Ohio, 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
Richmond Behavorial Associates
🇺🇸
Staten Island, New York, United States
Associated Neurologists of Southern Connecticut
🇺🇸
Fairfield, Connecticut, United States
Kentucky Medical Research Center
🇺🇸
Lexington, Kentucky, United States
Institute for Behavioral Medicine
🇺🇸
Smyrna, Georgia, United States
Mercy Health Research
🇺🇸
Saint 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
North Star Research
🇺🇸
Middleburg Heights, Ohio, United States
Neuropsychiatric Center
🇺🇸
Oklahoma City, Oklahoma, United States
Altoona Center for Clinical Research
🇺🇸
Duncansville, Pennsylvania, United States
NeuroScience, Inc.
🇺🇸
Herndon, Virginia, 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.
🇮🇳
Raipur, India