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A Study for Adolescents With Fibromyalgia Syndrome

This study has been terminated.
(Terminated due to study design changes; zero patients randomized to treatment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01089621
First Posted: March 18, 2010
Last Update Posted: August 24, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Eli Lilly and Company
  Purpose
The purpose of this study is to evaluate the possibility of conducting a larger study in adolescents with fibromyalgia syndrome.

Condition Intervention Phase
Fibromyalgia Drug: Duloxetine Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Feasibility Study of Duloxetine in Adolescents With Juvenile Primary Fibromyalgia Syndrome: A Pilot Study

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Rate of enrollment [ Time Frame: 6 months of enrollment ]
  • Rate of retention [ Time Frame: 12 weeks of treatment ]

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

Enrollment: 0
Study Start Date: March 2010
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Duloxetine Drug: Duloxetine
30 mg to 120 mg administered orally, daily for 12 weeks
Other Names:
  • Cymbalta
  • LY248686

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01089621


Locations
United States, Arizona
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, 85032
United States, Connecticut
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, 06824
United States, Missouri
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.
St Louis, Missouri, United States, 63141
United States, New York
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, United States, 10312
United States, Ohio
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, 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
United States, Oklahoma
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, 73109
United States, Oregon
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, 97210
United States, Utah
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, 84102
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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) Eli Lilly and Company
  More Information

Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT01089621     History of Changes
Other Study ID Numbers: 12865
F1J-MC-HMGE ( Other Identifier: Eli Lilly and Company )
First Submitted: March 17, 2010
First Posted: March 18, 2010
Last Update Posted: August 24, 2010
Last Verified: August 2010

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Duloxetine Hydrochloride
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents
Psychotropic Drugs
Dopamine Agents