NCT00190866已完成3 期
Dose Response Study of Duloxetine Versus Placebo in the Treatment of Fibromyalgia Syndrome
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 210
- 试验地点
- 35
- 主要终点
- Assess efficacy of duloxetine versus placebo on the treatment of pain in patients with fibromyalgia syndrome
研究概览
简要总结
To assess the efficacy of Duloxetine compared with placebo in the treatment of pain in patients with Fibromyalgia syndrome, with or without major depressive disorder.
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
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
- •Meet criteria for primary Fibromyalgia Syndrome as defined by the American College of Rheumatology
排除标准
- •Have any current primary Axis I diagnosis other than major depressive disorder
- •Have any current or previous diagnosis of psychosis, bipolar disorder, or schizoaffective disorder
- •Have any primary diagnosis of anxiety disorder within the past year (including panic disorder, agoraphobia, OCD, PTSD, GAD and social phobia)
- •Have regional pain syndrome, multiple surgeries or failed back syndrome
- •Have a confirmed current or previous diagnosis of rheumatoid arthritis, inflammatory arthritis, or infective arthritis, or an autoimmune disease (e.g. lupus)
结局指标
主要结局
Assess efficacy of duloxetine versus placebo on the treatment of pain in patients with fibromyalgia syndrome
次要结局
- Sheehan Disability Scale total score
- Average pain item of the BPI and the endpoint of the PGI-Improvement
- Reduction of pain severity
- Evaluate efficacy through the following: Fibromyalgia Impact Questionnaire, CGI-Severity, Tender-point pain thresholds, Multidimensional Fatigue Inventory, BPI average pain score, BPI severity and Interference scores
- Quality of life
- Effect duloxetine on pain is independent of MDD or mood improvement
- Assess safety of duloxetine
研究者
研究点 (35)
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