A Study for Adult Patients With Fibromyalgia

• Status: Completed
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The main purpose of this study is to determine if 30 milligrams (mg) of duloxetine is effective in the treatment of fibromyalgia compared to placebo.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Meet study criteria for fibromyalgia diagnosis.

Exclusion Criteria:

• Have previously or are currently taking duloxetine.

• Have been diagnosed with certain psychoses, bipolar or schizoaffective disorder

• Have pain symptoms that are difficult to differentiate from fibromyalgia.

• Have seizure disorder, uncontrolled narrow angle glaucoma, or acute liver injury (such as hepatitis) or severe cirrhosis.

• Have had any primary Axis 1 diagnosis other than major depressive disorder or generalized anxiety disorder within the past year.

• Are pregnant or breast-feeding

• Have a current or previous diagnosis of rheumatoid, infectious or inflammatory arthritis or an autoimmune disease

• Have a regional pain syndrome, failed back syndrome or chronic localized pan related to any past surgery

• Have a serious unstable medical illness

• Have a history of substance abuse or dependence within the past year