A 14-week, Multi-center Study of [S,S]-Reboxetine in Patients With Fibromyalgia.

• Status: Completed
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a study to investigate the effectiveness and safety of [S,S]-Reboxetine in relieving the symptoms of Fibromyalgia in patients. A previous study demonstrated clinically meaningful treatment effects in fibromyalgia, based on pain and functional endpoints.

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

Details

• Lead Sponsor: Pfizer
• Treatments: Reboxetine

Criteria

Inclusion Criteria:

• Male or female of any race, at least 18 years of age

• Patients must meet the ACR criteria for fibromyalgia (ie, widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites)

Exclusion Criteria:

• Patients with other severe pain (eg, Diabetic Peripheral Neuropathy and PostHerpetic Neuralgia) that may confound assessment or self evaluation of the pain associated with fibromyalgia

• Patients with any autoimmune rheumatic disorder, non-focal rheumatic disease (other than fibromyalgia), active infection, or untreated endocrine disorder

• A current or recent diagnosis (last 6 months) or episode of major depressive disorder, dysthymia and/or uncontrolled depression

• History of mania, hypomania, other psychotic disorder, or current mood disorder with psychotic features