Maintenance of Efficacy.

• Status: Withdrawn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

Summary

The hypothesis of Study A6061054 is to demonstrate superiority of efficacy of esreboxetine at 3 and 6 months compared to placebo.

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

Details

• Lead Sponsor: Pfizer

Criteria

Inclusion Criteria:

• Subjects must meet the American College of Rheumatology (ACR) criteria for fibromyalgia

• Pain score greater than or equal to 4 on an 11-point NRS

• FIQ-Total score greater than or equal to 45 points

Exclusion Criteria:

• Other severe pain that may confound assessment or self evaluation of the pain associated with fibromyalgia

• Any autoimmune rheumatic disorder, non-focal rheumatic disease (other than fibromyalgia), clinically significant active infection, or untreated endocrine disorder

• Uncontrolled hypertension Pending Worker's Compensation; Current or recent diagnosis or episode of major depressive disorder, dysthymia and/or uncontrolled depression; Subjects to be at risk of suicide;