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A Study of Duloxetine in Adolescents With Juvenile Primary Fibromyalgia Syndrome

Information source: Eli Lilly and Company
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Fibromyalgia

Intervention: Duloxetine (Drug); Placebo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Eli Lilly and Company

Official(s) and/or principal investigator(s):
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, Affiliation: Eli Lilly and Company

Overall contact:
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or, Phone: 1-317-615-4559

Summary

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.

Clinical Details

Official title: Effect of Duloxetine 30/60 mg Once Daily Versus Placebo in Adolescents With Juvenile Primary Fibromyalgia Syndrome

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change from baseline to 13 week endpoint in Brief Pain Inventory (BPI) modified short form-adolescent version 24 hour average pain severity item

Secondary outcome:

Change from baseline to 13 week endpoint in Brief Pain Inventory (BPI) modified short form-adolescent version severity and interference items

Maintenance effect in acute phase responders on the Brief Pain Inventory (BPI) modified short form-adolescent version 24 hour average pain severity item

Proportion of patients with greater than or equal to 30% and 50% reduction in BPI 24 hour average pain severity score at 13 weeks

Change from baseline in Pediatric Pain Questionnaire (PPQ) item scores

Change from baseline in Clinical Global Impression (CGI) Severity: overall score and mental illness score

Change from baseline in Functional Disability Inventory (FDI) child scale and rent scale

Change from baseline in Children's Depression Inventory (CDI)

Change from baseline in Multidimensional Anxiety Scale for Children (MASC)

Eligibility

Minimum age: 13 Years. Maximum age: 17 Years. Gender(s): Both.

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

Locations and Contacts

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

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., Buenos Aires C1270AAN, Argentina; Recruiting
Eli Lilly and Company

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., San Miguel De Tucuman T4000AXL, Argentina; Recruiting
Eli Lilly and Company

Centro de Investigaciones Clinicas, San Juan 00912, Puerto Rico; Recruiting
Phone: 7879999453
Annette Lopez, Principal Investigator

GCM Medical Group PSC, San Juan 00909, Puerto Rico; Not yet recruiting
Phone: 787-726-8396
Gregorio Cortes-Maisonet, Principal Investigator

NoesisPharma, Phoenix, Arizona 85032, United States; Recruiting
Phone: 602-795-1834
Lee Kelley, Principal Investigator

Connecticut Clinical Trials LLC, Cromwell, Connecticut 06416, United States; Recruiting
Phone: 860-632-0144
C. Brendan Montano, Principal Investigator

Institute for Behavioral Medicine, Smyrna, Georgia 30080, United States; Recruiting
Phone: 770-319-8013
Ashraf Attalla, Principal Investigator

Healthy Perspectives Innovative Mental Health Services, PL, Nashua, New Hampshire 03060, United States; Recruiting
Phone: 603-758-6810
Hisham Hafez, Principal Investigator

Albuquerque Neurosciences, Albuquerque, New Mexico 87109, United States; Recruiting
Phone: 505-848-3773
Glenn Dempsey, Principal Investigator

Bioscience Research, LLC, Mount Kisco, New York 10549, United States; Recruiting
Phone: 914-385-0200
David Krakow, Principal Investigator

Univ of Cincinnati College of Medicine, Cincinnati, Ohio 45219, United States; Recruiting
Phone: 513-558-7104
Lesley Arnold, Principal Investigator

Neuropsychiatric Center, Oklahoma City, Oklahoma 73109, United States; Recruiting
Phone: 405-634-5529
Siavash Nael, Principal Investigator

Altoona Center for Clinical Research, Duncansville, Pennsylvania 16635, United States; Recruiting
Phone: 814-693-0300
Alan Kivitz, Principal Investigator

Arthritis and Osteoporosis Center of South Texas, San Antonio, Texas 78232, United States; Completed

The Fatigue Consultation Clinic, Salt Lake City, Utah 84102, United States; Recruiting
Phone: 801-532-8311
Lucinda Bateman, Principal Investigator

Additional Information

Starting date: March 2011
Last updated: August 19, 2015

Page last updated: August 20, 2015

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