A Study of Duloxetine in Adolescents With Juvenile Primary Fibromyalgia Syndrome

Fibromyalgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01237587
• Other study ID #: 14099
• Secondary ID: F1J-MC-HMGWCTRI/
• Status: Completed
• Phase: Phase 3
• Start date: March 2011
• Est. completion date: November 28, 2017

Study information

• Verified date: September 2019
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 184
• Est. completion date: November 28, 2017
• Est. primary completion date: May 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

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• Previously completed or withdrawn after randomization from a study investigating duloxetine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

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Drug:
• Duloxetine
Administered orally
• Placebo
Administered orally

Locations

Country	Name	City	State
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.	San Miguel De Tucuman
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.	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
Puerto Rico	Centro de Investigaciones Clinicas	San Juan
Puerto Rico	Centro Pediatrico Paseos	San Juan
United States	Albuquerque Neurosciences	Albuquerque	New Mexico
United States	Northwest Clinical Research Center	Bellevue	Washington
United States	Neurobehavioral Clinical Research	Canton	Ohio
United States	Univ of Cincinnati College of Medicine	Cincinnati	Ohio
United States	Connecticut Clinical Trials LLC	Cromwell	Connecticut
United States	Altoona Center for Clinical Research	Duncansville	Pennsylvania
United States	Associated Neurologists of Southern Connecticut	Fairfield	Connecticut
United States	NeuroScience, Inc.	Herndon	Virginia
United States	Riley Hosptial for Children	Indianapolis	Indiana
United States	Holston Medical Group Clinical Research	Kingsport	Tennessee
United States	Kentucky Medical Research Center	Lexington	Kentucky
United States	Loma Linda University School of Medicine	Loma Linda	California
United States	North Star Research	Middleburg Heights	Ohio
United States	Bioscience Research, LLC	Mount Kisco	New York
United States	Healthy Perspectives Innovative Mental Health Services, PL	Nashua	New Hampshire
United States	Synergy Clinical Research	National City	California
United States	Neuropsychiatric Center	Oklahoma City	Oklahoma
United States	CRI Lifetree	Philadelphia	Pennsylvania
United States	NoesisPharma	Phoenix	Arizona
United States	Mercy Health Research	Saint Louis	Missouri
United States	Bateman Horne Center of Excellence	Salt Lake City	Utah
United States	Arthritis and Osteoporosis Center of South Texas	San Antonio	Texas
United States	Institute for Behavioral Medicine	Smyrna	Georgia
United States	Richmond Behavorial Associates	Staten Island	New York
United States	Advanced Pain Management	Virginia Beach	Virginia
United States	Palm Beach Research Center	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Argentina,  India,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change From Baseline to 13 Week Endpoint in Brief Pain Inventory (BPI) Modified Short Form-Adolescent Version Severity and Interference Items	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.	Baseline, 13 weeks
Secondary	Maintenance Effect in Acute Phase Responders on the 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.; 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.	Baseline (Extension Phase), 39 weeks
Secondary	Number of Participants With Greater Than or Equal to 30% Reduction From Baseline in BPI 24 Hour Average Pain Severity Score at 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).	13 weeks
Secondary	Number of Participants With Greater Than or Equal to 50% Reduction From Baseline in BPI 24 Hour Average Pain Severity Score at 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).	13 weeks
Secondary	Change From Baseline in Pediatric Pain Questionnaire (PPQ) Item Scores	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 treatment, pooled investigator and baseline value.	Baseline, 13 weeks
Secondary	Change From Baseline in Clinical Global Impression (CGI) Severity: Overall Illness Score	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 treatment, pooled investigator and baseline value.	Baseline, 13 weeks
Secondary	Change From Baseline in Clinical Global Impression (CGI) Severity: Mental Illness Score	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 treatment, pooled investigator and baseline value.	Baseline, 13 weeks
Secondary	Change From Baseline in Functional Disability Inventory Child Form (FDI-Child)	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.	Baseline, 13 weeks
Secondary	Change From Baseline in Functional Disability Inventory Parent Form (FDI-Parent)	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.	Baseline, 13 weeks
Secondary	Change From Baseline in Children's Depression Inventory (CDI)	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 treatment, pooled investigator and baseline value.	Baseline, 13 weeks
Secondary	Change From Baseline in Multidimensional Anxiety Scale for Children (MASC)	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.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.	Baseline, 13 weeks
Secondary	Change From Baseline to 39 Week Endpoint in Brief Pain Inventory (BPI) Modified Short Form-adolescent Version Severity and Interference Items	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.	Baseline (extension phase), 39 weeks
Secondary	Change From Baseline in Pediatric Pain Questionnaire (PPQ) Item Scores	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.	Baseline (extension phase), 39 weeks
Secondary	Change From Baseline in Clinical Global Impression (CGI) Severity: Overall Illness Score	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.	Baseline (extension phase), 39 weeks
Secondary	Change From Baseline in Clinical Global Impression (CGI) Severity: Mental Illness Score	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.	Baseline (extension phase), 39 weeks
Secondary	Change From Baseline in Functional Disability Inventory Child Form (FDI-child)	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.	Baseline (extension phase), 39 weeks
Secondary	Change From Baseline in Functional Disability Inventory Parent Form (FDI-parent)	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.	Baseline (extension phase), 39 weeks
Secondary	Change From Baseline in Children's Depression Inventory (CDI)	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.	Baseline (extension phase), 39 weeks
Secondary	Change From Baseline in Multidimensional Anxiety Scale for Children (MASC)	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.	Baseline (extension phase), 39 weeks

External Links

•   Click here for more information about this study: A Study of Duloxetine in Adolescents With Juvenile Primary Fibromyalgia Syndrome