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Study of Duloxetine Versus Placebo in the Treatment of Fibromyalgia Syndrome

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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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

35

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Data sourced from clinicaltrials.gov

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