A Study for Adolescents With Fibromyalgia Syndrome

An Open-label Feasibility Study of Duloxetine in Adolescents With Juvenile Primary Fibromyalgia Syndrome: A Pilot Study

The purpose of this study is to evaluate the possibility of conducting a larger study in adolescents with fibromyalgia syndrome.

Study Overview

• Status: Withdrawn
• Conditions: Fibromyalgia
• Intervention / Treatment: Drug: Duloxetine

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85032
      • 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.
  • Connecticut
    • Fairfield, Connecticut, United States, 06824
      • 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.
  • Missouri
    • Saint Louis, Missouri, United States, 63141
      • 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.
  • New York
    • Staten Island, New York, United States, 10312
      • 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.
  • Ohio
    • Canton, Ohio, United States, 44718
      • 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.
    • Cincinnati, Ohio, United States, 45219
      • 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.
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73109
      • 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.
  • Oregon
    • Portland, Oregon, United States, 97210
      • 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.
  • Utah
    • Salt Lake City, Utah, United States, 84102
      • 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.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Meet criteria for juvenile primary fibromyalgia syndrome as defined by Yunus and Masi.
• Have a score of greater than or equal to 40mm on item 3 of the Pediatric Pain Questionnaire at screening and treatment baseline.
• Female patients must have a negative pregnancy test at baseline and must agree to abstain from sexual activity or use a reliable method of birth control.
• Patients must be capable of swallowing study drug whole.
• Patients must have venous access sufficient to allow blood sampling and be compliant with blood draws as per the protocol.

Exclusion Criteria:

• Are 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 are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
• Have pain symptoms related to traumatic injury, past surgery, structural bone or joint disease (such as osteoarthritis, bursitis, tendonitis), or regional pain syndrome that will interfere with the interpretation of outcome measures.
• Have a confirmed current or previous diagnosis of rheumatoid arthritis, inflammatory arthritis, or infectious arthritis, or an autoimmune disease.
• Have any primary Axis diagnosis OTHER than major depressive disorder (MDD) and/or generalized disorder (GAD) as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV), currently or within the past year. Patients with specific phobias may participate in this study.
• Have any lifetime DSM-IV Axis I diagnosis of psychosis, bipolar disorder, or schizoaffective disorder.
• Have any DSM-IV Axis II disorder which, in the judgment of the investigator, would interfere with protocol compliance.
• Have a history of substance abuse or dependence within the past year, excluding nicotine and caffeine.
• Have a positive urine drug screen for any substances of abuse or excluded medication.
• Have a family history of 1 or more first-degree relatives (parents or siblings) with diagnosed bipolar I disorder.
• Have a significant suicide attempt within 1 year of screening or are currently at suicidal risk in the opinion of the investigator.
• Have a weight less than 20 kg at any screening phase.
• Have initiated, stopped, or changed the type or intensity of psychotherapy within 3 months prior to screening.
• Have a history of seizure disorder (other than febrile seizures).
• Have abnormal thyroid-stimulating hormone (TSH) concentrations. Patients with hypothyroidism who have been treated on a stable dose of thyroid supplement for at least the past 3 months and have medically appropriate TSH concentrations, and are clinically euthyroid may participate in the study.
• Have acute liver injury or sever cirrhosis.
• Have previously taken duloxetine.
• Have a serious or unstable medical illness.
• Have initiated or discontinued hormone therapy within the previous 3 months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Duloxetine	Drug: Duloxetine; 30 mg to 120 mg administered orally, daily for 12 weeks; Other Names: Cymbalta; LY248686

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of enrollment	6 months of enrollment
Rate of retention	12 weeks of treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in score from baseline to endpoint on the Pediatric Pain Questionnaire (PPQ)	Baseline, 12 weeks
Change in score from baseline to endpoint on the Brief Pain Inventory (BPI) modified short form severity	Baseline, 12 weeks
Change in score from baseline to endpoint on the Clinical Global Impression of Severity, overall (CGI-Severity: overall) scale	Baseline, 12 weeks
Endpoint score of Patient Global Impression of Improvement (PGI-I) scale	12 weeks
Change in score from baseline to endpoint on the Functional Disability Inventory - child version (FDI-child) scale	Baseline, 12 weeks
Change in score from baseline to endpoint on the Functional Disability Inventory - parent version (FDI-parent) scale	Baseline, 12 weeks
Change in score from baseline to endpoint on the Clinical Global Impression of Severity for Mental Illness (CGI-mental illness) scale	Baseline, 12 weeks
Change in score from baseline to endpoint on the Children's Depression Inventory (CDI)	Baseline, 12 weeks
Change in score from baseline to endpoint on the Multidimensional Anxiety Scale for Children (MASC)	Baseline, 12 weeks
Columbia Suicide-Severity Rating Scale (CSSRS)	During 12 weeks of treatment
Change in score from baseline to endpoint on the Pediatric Quality of Life Inventory - teen report (PedsQL)	Baseline, 12 weeks
Number of patients with treatment emergent abnormal laboratory values	During 12 weeks of treatment
Change from baseline to endpoint in blood pressure	Baseline, 12 weeks
Change from baseline to endpoint in heart rate	Baseline, 12 weeks
Change from baseline to endpoint in weight	Baseline, 12 weeks
Change from baseline to endpoint in height	Baseline, 12 weeks
Number of patients with treatment emergent abnormal electrocardiogram	During 12 weeks of treatment

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2010
• Primary Completion (Anticipated): August 1, 2010
• Study Completion (Anticipated): August 1, 2010

Study Registration Dates

• First Submitted: March 17, 2010
• First Submitted That Met QC Criteria: March 17, 2010
• First Posted (Estimate): March 18, 2010

Study Record Updates

• Last Update Posted (Actual): November 4, 2019
• Last Update Submitted That Met QC Criteria: October 31, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Dopamine Agents; Serotonin and Noradrenaline Reuptake Inhibitors; Duloxetine Hydrochloride
• Other Study ID Numbers: 12865; F1J-MC-HMGE (Other Identifier: Eli Lilly and Company)