NCT00612170已完成3 期
A 14-week, Randomized, Double-blind, Placebo-controlled, Multi-center Study of [S,S]-Reboxetine (PNU-165442G) Administered Once Daily (O.D.) 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
- 已完成
- 发起方
- Pfizer
- 入组人数
- 1,129
- 试验地点
- 1
- 主要终点
- Change from baseline in the endpoint mean pain score
研究概览
简要总结
This is a study to investigate the effectiveness and safety of [S,S]-Reboxetine in relieving the symptoms of Fibromyalgia in patients. A previous study demonstrated clinically meaningful treatment effects in fibromyalgia, based on pain and functional endpoints.
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
- •Male or female of any race, at least 18 years of age
- •Patients must meet the ACR criteria for fibromyalgia (ie, widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites)
排除标准
- •Patients with other severe pain (eg, Diabetic Peripheral Neuropathy and PostHerpetic Neuralgia) that may confound assessment or self evaluation of the pain associated with fibromyalgia
- •Patients with any autoimmune rheumatic disorder, non-focal rheumatic disease (other than fibromyalgia), active infection, or untreated endocrine disorder
- •A current or recent diagnosis (last 6 months) or episode of major depressive disorder, dysthymia and/or uncontrolled depression
- •History of mania, hypomania, other psychotic disorder, or current mood disorder with psychotic features
研究组 & 干预措施
3
Experimental
干预措施: [S,S]-Reboxetine (Drug)
4
Sham Comparator
干预措施: Placebo (Drug)
1
Experimental
干预措施: [S,S]-Reboxetine (Drug)
2
Experimental
干预措施: [S,S]-Reboxetine (Drug)
结局指标
主要结局
Change from baseline in the endpoint mean pain score
时间窗: 14 weeks
Fibromyalgia Impact Questionnaire
时间窗: 14 weeks
次要结局
- Patient Global Impression of Change(14 weeks)
- Hospital Anxiety and Depression Scale(14 weeks)
- Short Form 36(14 weeks)
- Change from baseline in the endpoint mean sleep interference score(14 weeks)
- Multidimensional Assessment of Fatigue(14 weeks)
- Sheehan Disability Score(14 weeks)
- Pain Visual Analogue Scale(14 weeks)
研究者
研究点 (1)
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