A Study for Adolescents With Fibromyalgia Syndrome

Fibromyalgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01089621
• Other study ID #: 12865
• Secondary ID: F1J-MC-HMGE
• Status: Withdrawn
• Phase: Phase 4
• Start date: March 2010
• Est. completion date: August 2010

Study information

• Verified date: October 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 evaluate the possibility of conducting a larger study in adolescents with fibromyalgia syndrome.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Drug:
• Duloxetine
30 mg to 120 mg administered orally, daily for 12 weeks

Locations

Country	Name	City	State
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.	Canton	Ohio
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.	Cincinnati	Ohio
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.	Fairfield	Connecticut
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.	Oklahoma City	Oklahoma
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.	Phoenix	Arizona
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.	Portland	Oregon
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.	Saint Louis	Missouri
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.	Salt Lake City	Utah
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.	Staten Island	New York

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of enrollment		6 months of enrollment
Primary	Rate of retention		12 weeks of treatment
Secondary	Change in score from baseline to endpoint on the Pediatric Pain Questionnaire (PPQ)		Baseline, 12 weeks
Secondary	Change in score from baseline to endpoint on the Brief Pain Inventory (BPI) modified short form severity		Baseline, 12 weeks
Secondary	Change in score from baseline to endpoint on the Clinical Global Impression of Severity, overall (CGI-Severity: overall) scale		Baseline, 12 weeks
Secondary	Endpoint score of Patient Global Impression of Improvement (PGI-I) scale		12 weeks
Secondary	Change in score from baseline to endpoint on the Functional Disability Inventory - child version (FDI-child) scale		Baseline, 12 weeks
Secondary	Change in score from baseline to endpoint on the Functional Disability Inventory - parent version (FDI-parent) scale		Baseline, 12 weeks
Secondary	Change in score from baseline to endpoint on the Clinical Global Impression of Severity for Mental Illness (CGI-mental illness) scale		Baseline, 12 weeks
Secondary	Change in score from baseline to endpoint on the Children's Depression Inventory (CDI)		Baseline, 12 weeks
Secondary	Change in score from baseline to endpoint on the Multidimensional Anxiety Scale for Children (MASC)		Baseline, 12 weeks
Secondary	Columbia Suicide-Severity Rating Scale (CSSRS)		During 12 weeks of treatment
Secondary	Change in score from baseline to endpoint on the Pediatric Quality of Life Inventory - teen report (PedsQL)		Baseline, 12 weeks
Secondary	Number of patients with treatment emergent abnormal laboratory values		During 12 weeks of treatment
Secondary	Change from baseline to endpoint in blood pressure		Baseline, 12 weeks
Secondary	Change from baseline to endpoint in heart rate		Baseline, 12 weeks
Secondary	Change from baseline to endpoint in weight		Baseline, 12 weeks
Secondary	Change from baseline to endpoint in height		Baseline, 12 weeks
Secondary	Number of patients with treatment emergent abnormal electrocardiogram		During 12 weeks of treatment