NCT00796601撤回3 期
A 6-month, Double-blind, Placebo-controlled, Multi-center, Parallel Group, Maintenance Of Effect Study Of Esreboxetine (Pnu-165442g) Administered Once Daily (qd) In Patients With Fibromyalgia
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- Pfizer
- 主要终点
- 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).
研究概览
简要总结
The hypothesis of Study A6061054 is to demonstrate superiority of efficacy of esreboxetine at 3 and 6 months compared to placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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;
研究组 & 干预措施
Esreboxetine
Experimental
干预措施: Esreboxetine (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
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).
时间窗: 6 months
Change from baseline to 3 and 6 months in the FIQ-Total score
时间窗: 6 months
次要结局
- Work productivity;(6 months)
- Global efficacy measures PGIC);(6 months)
- Sleep (MOS);(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)
研究者
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