Status:
WITHDRAWN
Maintenance of Efficacy.
Lead Sponsor:
Pfizer
Conditions:
Fibromyalgia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The hypothesis of Study A6061054 is to demonstrate superiority of efficacy of esreboxetine at 3 and 6 months compared to placebo.
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00796601
Start Date
May 1 2009
End Date
November 1 2010
Last Update
November 29 2018
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