FibromyalgiaPhase 4NCT01089621
A Study for Adolescents With Fibromyalgia Syndrome
A Phase 4 study testing Duloxetine in people with Fibromyalgia, run by Eli Lilly and Company at 9 sites in United States.
Trial summary
The purpose of this study is to evaluate the possibility of conducting a larger study in adolescents with fibromyalgia syndrome. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Duloxetine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 9 sitesUnited States
- Study dates
- Mar 2010to Aug 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 18Show fewer
- 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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
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, 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, 45219
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, 06824
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, 73109
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, 85032
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, 97210
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, 84102
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, 63141
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, 10312
About this study
Official title: An Open-label Feasibility Study of Duloxetine in Adolescents With Juvenile Primary Fibromyalgia Syndrome: A Pilot Study
The purpose of this study is to evaluate the possibility of conducting a larger study in adolescents with fibromyalgia syndrome.
- Conditions
- Fibromyalgia
- Being tested
- Duloxetine
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DuloxetineDrug
Also called Cymbalta, LY248686
30 mg to 120 mg administered orally, daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Duloxetine | Experimental | Not described Receives: Drug: Duloxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of enrollment
Measured: 6 months of enrollment
Rate of retention
Measured: 12 weeks of treatment
Secondary outcomes (17)
Change in score from baseline to endpoint on the Pediatric Pain Questionnaire (PPQ)
Measured: Baseline, 12 weeks
Change in score from baseline to endpoint on the Brief Pain Inventory (BPI) modified short form severity
Measured: Baseline, 12 weeks
Change in score from baseline to endpoint on the Clinical Global Impression of Severity, overall (CGI-Severity: overall) scale
Measured: Baseline, 12 weeks
Endpoint score of Patient Global Impression of Improvement (PGI-I) scale
Measured: 12 weeks
Change in score from baseline to endpoint on the Functional Disability Inventory - child version (FDI-child) scale
Measured: Baseline, 12 weeks
Change in score from baseline to endpoint on the Functional Disability Inventory - parent version (FDI-parent) scale
Measured: Baseline, 12 weeks
Change in score from baseline to endpoint on the Clinical Global Impression of Severity for Mental Illness (CGI-mental illness) scale
Measured: Baseline, 12 weeks
Change in score from baseline to endpoint on the Children's Depression Inventory (CDI)
Measured: Baseline, 12 weeks
Change in score from baseline to endpoint on the Multidimensional Anxiety Scale for Children (MASC)
Measured: Baseline, 12 weeks
Columbia Suicide-Severity Rating Scale (CSSRS)
Measured: During 12 weeks of treatment
Change in score from baseline to endpoint on the Pediatric Quality of Life Inventory - teen report (PedsQL)
Measured: Baseline, 12 weeks
Number of patients with treatment emergent abnormal laboratory values
Measured: During 12 weeks of treatment
Change from baseline to endpoint in blood pressure
Measured: Baseline, 12 weeks
Change from baseline to endpoint in heart rate
Measured: Baseline, 12 weeks
Change from baseline to endpoint in weight
Measured: Baseline, 12 weeks
Change from baseline to endpoint in height
Measured: Baseline, 12 weeks
Number of patients with treatment emergent abnormal electrocardiogram
Measured: During 12 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2010 (estimated)
- Study startMar 2010 (estimated)
- Primary completionAug 2010 (estimated)
- Study completionAug 2010 (estimated)
Why it stopped: Terminated due to study design changes; zero patients enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01089621
- Sponsor's protocol ID
- 12865
- Other IDs
- F1J-MC-HMGE
- Status last verified
- Oct 2019
- First submitted
- 17 Mar 2010
- Last updated
- 4 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Feasibility Study of Duloxetine in Adolescents With Juvenile Primary Fibromyalgia Syndrome: A Pilot Study
- ClinicalTrials.gov ID
- NCT01089621
- Acronym / sponsor ID
- 12865
- Conditions
- Fibromyalgia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Terminated due to study design changes; zero patients enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Mar 2010 (estimated)
- Primary completion
- Aug 2010 (estimated)
- Study completion
- Aug 2010 (estimated)
- First posted
- 18 Mar 2010 (estimated)
- Results
- Not posted in the source record
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 study is to evaluate the possibility of conducting a larger study in adolescents with fibromyalgia syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Duloxetine | Experimental | Drug: Duloxetine |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
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 |
|---|---|---|
| DuloxetineAlso: Cymbalta, LY24868630 mg to 120 mg administered orally, daily for 12 weeks | Drug | Duloxetine |
Primary outcome
Rate of enrollment
Time frame: 6 months of enrollment
Rate of retention
Time frame: 12 weeks of treatment
17 secondary outcomes
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2019.
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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.
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) study director
Eli Lilly and Company
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Duloxetine in people with Fibromyalgia, run by Eli Lilly and Company at 9 sites 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 5 inclusion and 18 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: withdrawn, as of the sponsor's last update on 4 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Rate of enrollment (time frame: 6 months of enrollment). The study lists 2 primary outcomes in all. 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 4 Nov 2019.