Maintenance of Efficacy.
- Registration Number
- NCT00796601
- Lead Sponsor
- Pfizer
- Brief Summary
The hypothesis of Study A6061054 is to demonstrate superiority of efficacy of esreboxetine at 3 and 6 months compared to placebo.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - Esreboxetine Esreboxetine -
- Primary Outcome Measures
Name Time Method Change from baseline to 3 and 6 months in the mean daily pain rating score measured by the 11 point pain intensity Numerical Rating Scale (NRS). 6 months Change from baseline to 3 and 6 months in the FIQ-Total score 6 months
- Secondary Outcome Measures
Name Time Method Global efficacy measures PGIC); 6 months Sleep (MOS); 6 months Work productivity; 6 months Pain (including other measures of daily pain and responder analyses); 6 months Function (including sub-scales of the FIQ, responder analyses of FIQ and SF-36); 6 months Depression (HADS) 6 months Safety (vital signs, ECG, laboratory, suicidal ideation) 6 months