Duloxetine Versus Placebo for Fibromyalgia

• Status: Completed
• Trial end date: 2003-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Duloxetine Hydrochloride

Criteria

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.