A Study for Adolescents With Fibromyalgia Syndrome

This study has been terminated.
(Terminated due to study design changes; zero patients randomized to treatment)
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01089621
First received: March 17, 2010
Last updated: August 23, 2010
Last verified: August 2010
  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: 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 ] [ Designated as safety issue: No ]
  • Rate of retention [ Time Frame: 12 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in score from baseline to endpoint on the Pediatric Pain Questionnaire (PPQ) [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
  • Change in score from baseline to endpoint on the Brief Pain Inventory (BPI) modified short form severity [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
  • Change in score from baseline to endpoint on the Clinical Global Impression of Severity, overall (CGI-Severity: overall) scale [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
  • Endpoint score of Patient Global Impression of Improvement (PGI-I) scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change in score from baseline to endpoint on the Functional Disability Inventory - child version (FDI-child) scale [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
  • Change in score from baseline to endpoint on the Functional Disability Inventory - parent version (FDI-parent) scale [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change in score from baseline to endpoint on the Children's Depression Inventory (CDI) [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
  • Change in score from baseline to endpoint on the Multidimensional Anxiety Scale for Children (MASC) [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
  • Columbia Suicide-Severity Rating Scale (CSSRS) [ Time Frame: During 12 weeks of treatment ] [ Designated as safety issue: Yes ]
  • Change in score from baseline to endpoint on the Pediatric Quality of Life Inventory - teen report (PedsQL) [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
  • Number of patients with treatment emergent abnormal laboratory values [ Time Frame: During 12 weeks of treatment ] [ Designated as safety issue: Yes ]
  • Change from baseline to endpoint in blood pressure [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline to endpoint in heart rate [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline to endpoint in weight [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline to endpoint in height [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: Yes ]
  • Number of patients with treatment emergent abnormal electrocardiogram [ Time Frame: During 12 weeks of treatment ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   13 Years to 17 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT01089621     History of Changes
Other Study ID Numbers: 12865, F1J-MC-HMGE
Study First Received: March 17, 2010
Last Updated: August 23, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Duloxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Adrenergic Agents
Dopamine Uptake Inhibitors
Dopamine Agents
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2014