Duloxetine Versus Placebo in the Treatment of FMS

Lilly

Status and phase

Completed

Phase 3

Conditions

Fibromyalgia

Treatments

Drug: Placebo

Drug: Duloxetine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00233025

9072

F1J-MC-HMEF

Details and patient eligibility

About

To test the hypothesis that the efficacy and safety of duloxetine has beneficial effects of the reduction of pain severity as measured by the average pain item of the BPI and the PGI-I in patients with fibromyalgia syndrome.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

meet criteria from primary FMS as defined by the ACR: widespread aching pain in all four quadrants of the body and axial skeleton and greater than or equal to 11 of 18 tender points under digital palpation examination
measure average pain item of the BPI at Visits 1 and 2

Exclusion criteria

have pain symptoms related to traumatic injury, structural rheumatic disease, or regional rheumatic disease that will interfere with interpretation of outcome measures
have regional pain syndrome, multiple surgeries or failed back syndrome
have confirmed current or previous diagnosis of rheumatoid arthritis, inflammatory arthritis, or infectious arthritis, or an autoimmune disease (i.e. systemic lupus erythematosus)
have current primary Axis I diagnosis other than major depressive disorder (MDD), including a current diagnosis of dysthymia