Clinical trial NCT01089621: A Study for Adolescents With Fibromyalgia Syndrome
Official title: An Open-label Feasibility Study of Duloxetine in Adolescents With Juvenile Primary Fibromyalgia Syndrome: A Pilot Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Fibromyalgia
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2010-03-18
Enrollment: 0
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Rate of enrollment
timeFrame: 6 months of enrollment
measure: Rate of retention
timeFrame: 12 weeks of treatment
Secondary outcomes:
measure: Change in score from baseline to endpoint on the Pediatric Pain Questionnaire (PPQ)
timeFrame: Baseline, 12 weeks
measure: Change in score from baseline to endpoint on the Brief Pain Inventory (BPI) modified short form severity
timeFrame: Baseline, 12 weeks
measure: Change in score from baseline to endpoint on the Clinical Global Impression of Severity, overall (CGI-Severity: overall) scale
timeFrame: Baseline, 12 weeks
measure: Endpoint score of Patient Global Impression of Improvement (PGI-I) scale
timeFrame: 12 weeks
measure: Change in score from baseline to endpoint on the Functional Disability Inventory - child version (FDI-child) scale
timeFrame: Baseline, 12 weeks
measure: Change in score from baseline to endpoint on the Functional Disability Inventory - parent version (FDI-parent) scale
timeFrame: Baseline, 12 weeks
measure: Change in score from baseline to endpoint on the Clinical Global Impression of Severity for Mental Illness (CGI-mental illness) scale
timeFrame: Baseline, 12 weeks
measure: Change in score from baseline to endpoint on the Children's Depression Inventory (CDI)
timeFrame: Baseline, 12 weeks
measure: Change in score from baseline to endpoint on the Multidimensional Anxiety Scale for Children (MASC)
timeFrame: Baseline, 12 weeks
measure: Columbia Suicide-Severity Rating Scale (CSSRS)
timeFrame: During 12 weeks of treatment
measure: Change in score from baseline to endpoint on the Pediatric Quality of Life Inventory - teen report (PedsQL)
timeFrame: Baseline, 12 weeks
measure: Number of patients with treatment emergent abnormal laboratory values
timeFrame: During 12 weeks of treatment
measure: Change from baseline to endpoint in blood pressure
timeFrame: Baseline, 12 weeks
measure: Change from baseline to endpoint in heart rate
timeFrame: Baseline, 12 weeks
measure: Change from baseline to endpoint in weight
timeFrame: Baseline, 12 weeks
measure: Change from baseline to endpoint in height
timeFrame: Baseline, 12 weeks
measure: Number of patients with treatment emergent abnormal electrocardiogram
timeFrame: During 12 weeks of treatment
Other outcomes:
Locations:
city: Phoenix
country: United States
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.
state: Arizona
city: Fairfield
country: United States
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.
state: Connecticut
city: Saint Louis
country: United States
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.
state: Missouri
city: Staten Island
country: United States
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.
state: New York
city: Canton
country: United States
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.
state: Ohio
city: Cincinnati
country: United States
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.
state: Ohio
city: Oklahoma City
country: United States
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.
state: Oklahoma
city: Portland
country: United States
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.
state: Oregon
city: Salt Lake City
country: United States
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.
state: Utah
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: