Trial record 41 of 107 for:    fibromyalgia | Open Studies | Interventional Studies

A Study of Duloxetine in Adolescents With Juvenile Primary Fibromyalgia Syndrome

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Eli Lilly and Company
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01237587
First received: November 8, 2010
Last updated: July 18, 2014
Last verified: July 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change from baseline in Pediatric Pain Questionnaire (PPQ) item scores [ Time Frame: Baseline, 13 weeks ; Baseline (extension phase), 39 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change from baseline in Functional Disability Inventory (FDI) child scale and rent scale [ Time Frame: Baseline, 13 weeks ; Baseline (extension phase), 39 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Children's Depression Inventory (CDI) [ Time Frame: Baseline, 13 weeks ; Baseline (extension phase), 39 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Multidimensional Anxiety Scale for Children (MASC) [ Time Frame: Baseline, 13 weeks; Baseline (extension phase), 39 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 210
Study Start Date: February 2011
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: December 2015 (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

Ages Eligible for Study:   13 Years to 17 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01237587

Contacts
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559

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. Recruiting
Phoenix, Arizona, United States, 85032
Contact: Eli Lilly         
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. Recruiting
Cromwell, Connecticut, United States, 06416
Contact: Eli Lilly         
United States, Georgia
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. Recruiting
Smyrna, Georgia, United States, 30080
Contact: Eli Lilly         
United States, New Hampshire
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. Recruiting
Nashua, New Hampshire, United States, 03060
Contact: Eli Lilly         
United States, New Mexico
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. Recruiting
Albuquerque, New Mexico, United States, 87109
Contact: Eli Lilly         
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. Recruiting
Mount Kisco, New York, United States, 10549
Contact: Eli Lilly         
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. Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Eli Lilly         
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. Recruiting
Oklahoma City, Oklahoma, United States, 73109
Contact: Eli Lilly         
United States, Pennsylvania
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. Recruiting
Duncansville, Pennsylvania, United States, 16635
Contact: Eli Lilly         
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. Recruiting
Philadelphia, Pennsylvania, United States, 19139
Contact: Eli Lilly         
United States, Texas
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. Recruiting
San Antonio, Texas, United States, 78232
Contact: Eli Lilly         
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. Recruiting
Salt Lake City, Utah, United States, 84102
Contact: Eli Lilly         
Argentina
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. Recruiting
Buenos Aires, Argentina, C1270AAN
Contact: Eli Lilly         
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. Recruiting
La Plata, Argentina, 9000
Contact: Eli Lilly         
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. Recruiting
San Miguel De Tucuman, Argentina, T4000AXL
Contact: Eli Lilly         
Puerto Rico
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. Recruiting
Caguas, Puerto Rico, 00725
Contact: Eli Lilly         
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. Recruiting
San Juan, Puerto Rico, 00926
Contact: Eli Lilly         
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. Recruiting
Santurce, Puerto Rico, 00912
Contact: Eli Lilly         
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: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01237587     History of Changes
Other Study ID Numbers: 14099, F1J-MC-HMGW, CTRI/2011/07/001866
Study First Received: November 8, 2010
Last Updated: July 18, 2014
Health Authority: United States: Food and Drug Administration
Argentina: Ministry of Health
India: Ministry of Health

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

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

ClinicalTrials.gov processed this record on September 18, 2014