NCT00233025已完成3 期
Duloxetine 60/120mg 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
- 320
- 试验地点
- 35
- 主要终点
- assess efficacy of duloxetine (QD) vs placebo on pain in patients, w/ or w/o MDD during a 6-month therapy phase
研究概览
简要总结
To test the hypothesis that the efficacy and safety of duloxetine has beneficial effects of the reduction of pain severity as measured by the average pain item of the BPI and the PGI-I in patients with fibromyalgia syndrome.
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 from primary FMS as defined by the ACR: widespread aching pain in all four quadrants of the body and axial skeleton and greater than or equal to 11 of 18 tender points under digital palpation examination
- •measure average pain item of the BPI at Visits 1 and 2
排除标准
- •have pain symptoms related to traumatic injury, structural rheumatic disease, or regional rheumatic disease that will interfere with interpretation of outcome measures
- •have regional pain syndrome, multiple surgeries or failed back syndrome
- •have confirmed current or previous diagnosis of rheumatoid arthritis, inflammatory arthritis, or infectious arthritis, or an autoimmune disease (i.e. systemic lupus erythematosus)
- •have current primary Axis I diagnosis other than major depressive disorder (MDD), including a current diagnosis of dysthymia
结局指标
主要结局
assess efficacy of duloxetine (QD) vs placebo on pain in patients, w/ or w/o MDD during a 6-month therapy phase
evaluate change in pain measured by Brief Pain Inventory score
evaluate endpoint of patient-reported improvement on the Patient's Global Impression of Improvement scale
次要结局
- change from baseline to endpoint on Sheehan Disability Scale total score
- assess efficacy of duloxetine vs placebo in first 3-months of therapy measured by change in BPI average score and PGI-I endpoint
- evaluate between group differences (duloxetine and placebo) in the first 3-months measured by change in baseline to endpoint in SDS total score
- evaluate efficacy of duloxetine versus placebo during 6-month therapy as measured by:
- FIQ
- CGI-Severity
- Tender-point pain thresholds
- MFI
- Percent of patients with 50% improvement in BPI avg. pain score
- BPI Severity
- evaluate duloxetine 60/120mg (QD) versus placebo during 6-month therapy as measured by the following health outcome measures:
- SF-36
- EQ-5D
研究者
研究点 (35)
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