Fibromyalgia | Cymbalta for Fibromyalgia Pain - Predictive Value of Small Fiber Changed
Fibromyalgia research study
What is the primary objective of this study?
Subjects with Fibromyalgia who respond to Duloxetine have specific nerve fiber characteristics. This can be used to predict which future patients will respond to Duloxetine.
Who is eligible to participate?
Inclusion Criteria: Treatment Arm - Fibromyalgia Diagnosis - Female - Over the age of 18, under the age of 70 - Understands English - Not Pregnant/planning to become pregnant Exclusion Criteria: - No major psychiatric disorders - No major unconrolled systemic diseases which may require hospitalization in the next 6 months - Pregnant Inclusion Criteria: Control Arm - Female - Over the age of 18, under the age of 70 - Understands English - Not Pregnant/planning to become pregnant Exclusion Criteria: Control Arm - No major psychiatric disorders - No major unconrolled systemic diseases which may require hospitalization in the next 6 months - Pregnant
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Duloxetineoral tablet, 30mg daily for 1 week (titration up) oral tablet, 60mg daily for 8 weeks (treatment) oral tablet, 30mg daily for 1 week (titration down, if needed)
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
ControlControl subjects undergo a skin biopsy.
TreatmentSubjects in the treatment arm also undergo a skin biopsy, followed by 8 week treatment with Duloxetine.
Start Date: June 2012
Completed Date: January 2015
Phase: Phase 4
Primary Outcome: Pain Reduction
Study sponsors, principal investigator, and references
Principal Investigator: tobias moeller-bertram, MD
Lead Sponsor: University of California, San Diego