Study of Duloxetine Versus Placebo in the Treatment of Fibromyalgia Syndrome

Lilly

Status and phase

Completed

Phase 3

Conditions

Fibromyalgia

Treatments

Drug: Duloxetine

Drug: placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00190866

F1J-MC-HMCJ

6222

Details and patient eligibility

About

To assess the efficacy of Duloxetine compared with placebo in the treatment of pain in patients with Fibromyalgia syndrome, with or without major depressive disorder.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Meet criteria for primary Fibromyalgia Syndrome as defined by the American College of Rheumatology

Exclusion criteria

Have any current primary Axis I diagnosis other than major depressive disorder
Have any current or previous diagnosis of psychosis, bipolar disorder, or schizoaffective disorder
Have any primary diagnosis of anxiety disorder within the past year (including panic disorder, agoraphobia, OCD, PTSD, GAD and social phobia)
Have regional pain syndrome, multiple surgeries or failed back syndrome
Have a confirmed current or previous diagnosis of rheumatoid arthritis, inflammatory arthritis, or infective arthritis, or an autoimmune disease (e.g. lupus)