Duloxetine Versus Placebo for Fibromyalgia

Lilly

Status and phase: Completed; Phase 3

Conditions: Fibromyalgia

Treatments: Drug: placebo; Drug: duloxetine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00489073

6158

F1J-MC-HMCA

Details and patient eligibility

About

The primary purpose of this study is to determine if duloxetine reduces pain severity in patients with fibromyalgia.

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• You are male or female outpatient at least 18 years of age with fibromyalgia. Females of child-bearing potential must test negative on a pregnancy test at visit 1.

Exclusion criteria

• Serious or unstable cardiovascular, hepatic, renal, respiratory, or hematologic illness, symptomatic peripheral vascular disease, or other medical condition (including unstable hypertension and not clinically euthyroid) or psychological conditions that in the opinion of the investigator would compromise participation or be likely to lead to hospitalization during the course of the study.
• Abnormal thyroid-stimulating hormone concentrations.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind