Juvenile Primary Fibromyalgia Syndrome (JPFS)Phase 3NCT00115804
Safety and Efficacy of Fluoxetine in Juvenile Fibromyalgia
A Phase 3 study testing Fluoxetine in people with Juvenile Primary Fibromyalgia Syndrome (JPFS) and Fibromyalgia, run by University of Cincinnati at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Juvenile Primary Fibromyalgia Syndrome (JPFS), Fibromyalgia
- What is being tested?
- Fluoxetine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2005to Feb 2011
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Female or male outpatients 13 to 18 years of age.
- Fulfillment of the American College of Rheumatology (ACR) criteria for primary fibromyalgia.
- Ability to understand and cooperate with study procedures.
- Provision of parental written informed consent and verbal and written assent from the adolescent for participation in the study.
Who cannot join
- Unwillingness or inability on the part of the parent to provide written informed consent or for the adolescent to provide verbal and written assent.
- Lifetime history of psychosis, hypomania or mania.
- Diagnosis of alcohol or substance abuse or dependence within 6 months prior to screening visit.
- Patients judged to be at serious suicide or homicide risk.
- Girls who are pregnant or lactating. Girls of childbearing potential who are not using a medically accepted method of contraception (including barrier or hormonal methods).
- Clinically unstable medical or psychiatric conditions that could interfere with the absorption, metabolism, excretion, or safety of fluoxetine or interfere with the assessment of disease severity.
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- Inability to exclude traumatic injury, regional or structural rheumatic disease, or infectious arthropathy as the etiology of their relevant fibromyalgia symptoms and that would interfere with interpretation of outcome measures (e.g., osteoarthritis, bursitis, tendonitis).
- History of an autoimmune disease or inflammatory arthritis, such as systemic lupus erythematosis (SLE) or rheumatoid arthritis (RA).
- Treatment with a monoamine oxidase inhibitor, tricyclic, selective serotonin reuptake inhibitor (SSRI) antidepressant, or lithium within 2 weeks prior to beginning study medication.
- Treatment with analgesic medication (with the exception of acetaminophen and over-the-counter NSAIDs) within one week prior to beginning study medication.
- Treatment with any other excluded medication that cannot be discontinued at the screening visit.
- Previous treatment with fluoxetine.
- Treatment with any investigational medications within 30 days prior to screening.
Trial locations and contacts
1 site in 1 country.
United States1 site
Women's Health Research Program
Cincinnati, Ohio, 45219
About this study
Official title: An Open-Label Clinical Trial of Fluoxetine Treatment of Juvenile Primary Fibromyalgia Syndrome
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).
Read the detailed description
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.
- Being tested
- Fluoxetine
- Keywords
- Fibromyalgia, Juvenile
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluoxetineDrug
Also called Prozac
Fluoxetine po 10-60 mg/day for 12 weeks. Fluoxetine was started at 10 mg once daily. The dose was flexibly dosed based on pain efficacy and tolerability to a final dose between 10 and 60 mg once daily
| Study group | Role | What they receive |
|---|---|---|
| Fluoxetine | Experimental | All eligible patients were started on Fluoxetine at 10 mg once daily. The dose was flexibly dosed based on pain efficacy and tolerability to a final dose between 10 and 60 mg once daily. Receives: Drug: Fluoxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Pain Severity Score
The primary outcome measure was average pain severity on the Pediatric Pain Questionnaire's 100-mm visual analog scale.
(0=no pain and 100 = severe pain )
Measured: Daily on average in the past week.
Secondary outcomes (7)
The Clinical Global Impression of Severity
Measures severity of illness at the time of the assessment on a scale of 1 (normal, not at all ill) to 7 (among the most extremely ill).
Measured: at the time of the assessment
The Patient Global Impression of Improvement
Measures the patient's impression of improvement since baseline on a scale of 1 (very much better) to 7 (very much worse).
Measured: since baseline, at the time of the assessment
The Functional Disability Inventory-child Version
A self-report inventory that assesses patients' ability to perform a variety of daily physical, social, and recreational activities. The scale ranges from 0 (no disability) to 60 (severe disability).
Measured: Over the "last few days."
The Functional Disability Inventory-parent Version
Consists of the same 15 items as the child version but allows the parent to provide their perception of the child's difficulty in performing daily physical, social, and recreational activities. The score ranges from 0 (no disability) to 60 (severe disability).
Measured: Over the "last few days."
Children's Depression Inventory
A 27-item, self-report measure of depressive symptoms with a score range of 0 (no depressive symptoms) to 54 (severe depressive symptoms.
Measured: Over the past 2 weeks.
Multidimensional Anxiety Scale for Children
A 39-item self-report inventory that assesses four areas of anxiety symptoms (emotional, cognitive, physical, and behavioral). Score ranges from 0 (no anxiety symptoms) to 117 (severe anxiety symptoms).
Measured: Over the past week.
Fibromyalgia Impact Questionnaire Modified for Children
A 19 item self-report instrument that measures overall impact of fibromyalgia including assessments of function, pain, fatigue, sleep quality, stiffness, anxiety and depression. Score range from 0 (no impact) to 100 (severe impact).
Measured: Over the past week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2005 (estimated)
- Study startJun 2005
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Juvenile Primary Fibromyalgia Syndrome (JPFS)Studies of the same condition, open and under way.
- More trials run by University of CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lesley M. Arnold, M.D., University of Cincinnati
- Investigators
- Lesley M Arnold, M.D., Principal investigator, Women's Health Research Program
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00115804
- Sponsor's protocol ID
- 05-3-22-1
- Status last verified
- Feb 2017
- First submitted
- 26 Jun 2005
- Last updated
- 10 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Clinical Trial of Fluoxetine Treatment of Juvenile Primary Fibromyalgia Syndrome
- ClinicalTrials.gov ID
- NCT00115804
- Acronym / sponsor ID
- 05-3-22-1
- Keywords
- Fibromyalgia, Juvenile
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Study start
- Jun 2005
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 27 Jun 2005 (estimated)
- Results
- Posted 15 Feb 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fluoxetine | Experimental | Drug: FluoxetineAll eligible patients were started on Fluoxetine at 10 mg once daily. The dose was flexibly dosed based on pain efficacy and tolerability to a final dose between 10 and 60 mg once daily. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Female or male outpatients 13 to 18 years of age.
- Fulfillment of the American College of Rheumatology (ACR) criteria for primary fibromyalgia.
- Ability to understand and cooperate with study procedures.
- Provision of parental written informed consent and verbal and written assent from the adolescent for participation in the study.
Key exclusion criteria (13 listed)
- Unwillingness or inability on the part of the parent to provide written informed consent or for the adolescent to provide verbal and written assent.
- Lifetime history of psychosis, hypomania or mania.
- Diagnosis of alcohol or substance abuse or dependence within 6 months prior to screening visit.
- Patients judged to be at serious suicide or homicide risk.
- Girls who are pregnant or lactating. Girls of childbearing potential who are not using a medically accepted method of contraception (including barrier or hormonal methods).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FluoxetineAlso: ProzacFluoxetine po 10-60 mg/day for 12 weeks. Fluoxetine was started at 10 mg once daily. The dose was flexibly dosed based on pain efficacy and tolerability to a final dose between 10 and 60 mg once daily | Drug | Fluoxetine |
Primary outcome
Average Pain Severity Score
Time frame: Daily on average in the past week.
The primary outcome measure was average pain severity on the Pediatric Pain Questionnaire's 100-mm visual analog scale. (0=no pain and 100 = severe pain )
7 secondary outcomes
The Clinical Global Impression of Severity
Time frame: at the time of the assessment
The Patient Global Impression of Improvement
Time frame: since baseline, at the time of the assessment
The Functional Disability Inventory-child Version
Time frame: Over the "last few days."
The Functional Disability Inventory-parent Version
Time frame: Over the "last few days."
Children's Depression Inventory
Time frame: Over the past 2 weeks.
Multidimensional Anxiety Scale for Children
Time frame: Over the past week.
Fibromyalgia Impact Questionnaire Modified for Children
Time frame: Over the past week.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lesley M Arnold, M.D. principal investigator
Women's Health Research Program
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fluoxetine in people with Juvenile Primary Fibromyalgia Syndrome (JPFS) and Fibromyalgia, run by University of Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Feb 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average Pain Severity Score (time frame: Daily on average in the past week.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2017.