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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?

Fibromyalgia

Study Interventions

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)

Study Arms

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.

Study Status

Withdrawn

Start Date: June 2012

Completed Date: January 2015

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Pain Reduction

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: tobias moeller-bertram, MD

Lead Sponsor: University of California, San Diego

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01619566

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