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A Study of Duloxetine in Adolescents With Juvenile Primary Fibromyalgia Syndrome

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01237587
First Posted: November 9, 2010
Last Update Posted: August 1, 2017
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 (Responsible Party):
Eli Lilly and Company
  Purpose

The purpose of this study is to determine whether duloxetine is safe and effective in the treatment of adolescents with Juvenile Primary Fibromyalgia Syndrome (JPFS).

This trial consists of two distinct study periods. A blinded treatment period of 13 weeks and an open label extension period of 26 weeks.


Condition Intervention Phase
Fibromyalgia Drug: Duloxetine Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Duloxetine 30/60 mg Once Daily Versus Placebo in Adolescents With Juvenile Primary Fibromyalgia Syndrome

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Change from baseline to 13 week endpoint in Brief Pain Inventory (BPI) modified short form-adolescent version 24 hour average pain severity item [ Time Frame: Baseline, 13 weeks ]

Secondary Outcome Measures:
  • Change from baseline to 13 week endpoint in Brief Pain Inventory (BPI) modified short form-adolescent version severity and interference items [ Time Frame: Baseline, 13 weeks ; Baseline (extension phase), 39 weeks ]
  • Maintenance effect in acute phase responders on the Brief Pain Inventory (BPI) modified short form-adolescent version 24 hour average pain severity item [ Time Frame: Baseline (extension period), 39 weeks ]
  • Proportion of patients with greater than or equal to 30% and 50% reduction in BPI 24 hour average pain severity score at 13 weeks [ Time Frame: 13 weeks ]
  • Change from baseline in Pediatric Pain Questionnaire (PPQ) item scores [ Time Frame: Baseline, 13 weeks ; Baseline (extension phase), 39 weeks ]
  • Change from baseline in Clinical Global Impression (CGI) Severity: overall score and mental illness score [ Time Frame: Baseline, 13 weeks ; Baseline (extension phase), 39 weeks ]
  • Change from baseline in Functional Disability Inventory (FDI) child scale and rent scale [ Time Frame: Baseline, 13 weeks ; Baseline (extension phase), 39 weeks ]
  • Change from baseline in Children's Depression Inventory (CDI) [ Time Frame: Baseline, 13 weeks ; Baseline (extension phase), 39 weeks ]
  • Change from baseline in Multidimensional Anxiety Scale for Children (MASC) [ Time Frame: Baseline, 13 weeks; Baseline (extension phase), 39 weeks ]

Estimated Enrollment: 210
Study Start Date: March 2011
Estimated Study Completion Date: December 2017
Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Duloxetine

Blinded treatment period: 30mg or 60mg once daily for 13 weeks

Open label extension: 30mg or 60mg Duloxetine once daily for 26 weeks

Drug: Duloxetine
Administered orally
Other Names:
  • Cymbalta
  • LY248686
Placebo Comparator: Placebo

Blinded treatment period:Placebo once daily for 13 weeks

Open label extension: 30mg or 60mg Duloxetine once daily for 26 weeks

Drug: Duloxetine
Administered orally
Other Names:
  • Cymbalta
  • LY248686
Drug: Placebo
Administered orally

  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 primary JPFS
  • Have a score of greater than or equal to 4 on Brief Pain Inventory (BPI) average pain severity (Item 3) during screening
  • Female participants must have a negative serum pregnancy test during screening
  • Participant's parent/legal representative and participant judged to be reliable to keep all appointments for clinical tests and procedures
  • Participant's parent/legal representative and participant must have a degree of understanding such that they can communicate intelligently
  • Participants must be capable of swallowing investigational product whole
  • Participants must have venous access sufficient to allow blood sampling and be compliant with blood draws

Exclusion Criteria:

  • 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 concurrently enrolled in any other type of medical research
  • Previously completed or withdrawn after randomization from a study investigating duloxetine
  • Known hypersensitivity to duloxetine or any of the inactive ingredients, or have frequent or severe allergic reactions to multiple medications
  • Treated with duloxetine within the last 6 months. Will not likely benefit from duloxetine treatment, in the opinion of the investigator or have had prior nonresponse or inadequate tolerance to duloxetine
  • Pain symptoms related to traumatic injury, past surgery, structural bone or joint disease or regional pain syndrome that will interfere with interpretation of outcome measures
  • Currently have evidence of rheumatologic disorder or have a current diagnosis of rheumatoid arthritis, inflammatory arthritis, or infectious arthritis, or an autoimmune disease (for example, systemic lupus erythematosus)
  • Have a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) Axis I condition, currently or within the past year, except major depressive disorder (MDD) and/or generalized anxiety disorder (GAD), adjustment disorder or specific phobias with primary investigator approval
  • Have a current secondary DSM-IV Axis I condition of attention-deficit/hyperactivity disorder that requires pharmacologic treatment
  • Lifetime DSM-IV Axis I diagnosis of psychosis, bipolar disorder, or schizoaffective disorder
  • DSM-IV Axis II disorder which would interfere with protocol compliance
  • History of substance abuse or dependence within the 6 months
  • Positive urine drug screen for any substances of abuse or excluded medication
  • Family history of 1 or more first-degree relatives with diagnosed bipolar I disorder
  • Significant suicide attempt within 1 year of screening or are currently at suicidal risk in the opinion of the investigator
  • Weight less than 20 kilogram (kg) at screening
  • History of seizure disorder (other than febrile seizures)
  • Taking any excluded medications that cannot be discontinued at screening
  • Fluoxetine within 30 days prior to completion of screening
  • Monoamine oxidase inhibitor (MAOI) within 14 days of screening; or the potential need to use an MAOI during the study or within 5 days of discontinuation of investigational product
  • Abnormal thyroid-stimulating hormone (TSH) concentrations
  • Uncontrolled narrow-angle glaucoma
  • Acute liver injury (such as hepatitis) or severe cirrhosis (Child-Pugh Class C)
  • Serious or unstable medical illness
  • Female participants who are either pregnant, nursing or have recently given birth
  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): NCT01237587


  Show 33 Study Locations
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

Additional Information:
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01237587     History of Changes
Other Study ID Numbers: 14099
F1J-MC-HMGW ( Other Identifier: Eli Lilly and Company )
CTRI/2011/07/001866 ( Registry Identifier: Clinical Trials Registry India )
First Submitted: November 8, 2010
First Posted: November 9, 2010
Last Update Posted: August 1, 2017
Last Verified: July 2017

Keywords provided by Eli Lilly and Company:
Adolescents
Juvenile Primary Fibromyalgia Syndrome

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