Overview

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Withdrawn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;