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Sponsors and Collaborators: |
University of Cincinnati Arnold, Lesley, M., M.D. |
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Information provided by: | University of Cincinnati |
ClinicalTrials.gov Identifier: | NCT00115804 |
The purpose of this research is to conduct an open, pilot trial to assess the efficacy and safety of fluoxetine in the treatment of Juvenile Primary Fibromyalgia Syndrome (JPFS).
Condition | Intervention | Phase |
---|---|---|
Juvenile Primary Fibromyalgia Syndrome (JPFS) Fibromyalgia |
Drug: Fluoxetine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Open-Label Clinical Trial of Fluoxetine Treatment of Juvenile Primary Fibromyalgia Syndrome |
Estimated Enrollment: | 15 |
Study Start Date: | June 2005 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Fibromyalgia is a common condition that is often challenging to treat. It is defined by the American College of Rheumatology (ACR) as widespread pain of at least 3 months duration in combination with tenderness at 11 or more of 18 specific tender point sites on the body. The prevalence of JPFS in children and adolescents in the general population of the United States is unknown. Studies from Israel, Mexico, and Italy have estimated that the prevalence rate of JPFS in school children ranges from 1.24% to 6.20%, with girls making up the majority of cases. Information from a national registry in the United States indicates that JPFS accounts for about 7.7% of new patient diagnoses in a pediatric rheumatology setting. The mean age of onset of pediatric JPFS is 12 years. As in adults, JPFS has been diagnosed in children and adolescents using the ACR criteria. JPFS often leads to substantial morbidity and disability. For example, adolescents with JPFS reported significantly greater functional disability and greater number of school absences than those with other rheumatic diseases such as juvenile RA or lupus. The presence of high levels of pain and disability at this critical developmental stage place adolescents with JPFS at greater risk for long term social and occupational difficulties. Early diagnosis and effective intervention are therefore of critical importance.
Ages Eligible for Study: | 13 Years to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Elizabeth Mierenfeld, BA | 513-475-8113 | Elizabeth.Mierenfeld@uc.edu |
Contact: Susie Sheridan, B.A. | 513-475-8115 | susie.sheridan@uc.edu |
United States, Ohio | |
Women's Health Research Program | Recruiting |
Cincinnati, Ohio, United States, 45219 | |
Contact: Elizabeth Mierenfeld 513-475-8113 elizabeth.mierenfeld@uc.edu | |
Contact: Susie Sheridan, B.A. 513-475-8115 susie.sheridan@uc.edu | |
Principal Investigator: Lesley M Arnold, M.D. |
Principal Investigator: | Lesley M Arnold, M.D. | Women's Health Research Program |
Responsible Party: | University of Cincinnati College of Medicine ( Lesley M. Arnold, M.D. ) |
Study ID Numbers: | 05-3-22-1 |
Study First Received: | June 26, 2005 |
Last Updated: | June 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00115804 |
Health Authority: | United States: Institutional Review Board |
Fibromyalgia Juvenile |
Fluoxetine Muscular Diseases Neuromuscular Diseases Musculoskeletal Diseases Myofascial Pain Syndromes |
Fibromyalgia Pain Rheumatic Diseases Serotonin |
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Disease Molecular Mechanisms of Pharmacological Action Nervous System Diseases Physiological Effects of Drugs Psychotropic Drugs Serotonin Uptake Inhibitors |
Pharmacologic Actions Pathologic Processes Serotonin Agents Therapeutic Uses Syndrome Antidepressive Agents, Second-Generation Central Nervous System Agents Antidepressive Agents |