NCT00797797已完成3 期
A Multicenter, Randomized, Open-Label, Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Milnacipran When Added to Pregabalin in the Treatment of Fibromyalgia
Forest Laboratories6 个研究点 分布在 1 个国家目标入组 364 人开始时间: 2008年11月最近更新:
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
- 入组人数
- 364
- 试验地点
- 6
- 主要终点
- Patient Global Impression of Change (PGIC) Responder Rate at End of Study
研究概览
简要总结
To evaluate the safety, tolerability, and efficacy of milnacipran when taken with another drug called pregabalin in people with fibromyalgia.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of fibromyalgia defined by 1990 American College of Rheumatology (ACR) Criteria
- •tolerate at least 300 mg/day of pregabalin
- •have an incomplete response to pregabalin treatment
排除标准
- •suicidal risk
- •substance abuse
- •pulmonary dysfunction
- •renal impairment
- •active cardiac disease
- •liver disease
- •narrow angle glaucoma
- •autoimmune disease
- •inflammatory bowel disease
- •unstable endocrine disease
- •prostatic enlargement
研究组 & 干预措施
Milnacipran Added
Experimental
干预措施: Milnacipran Added (Drug)
No Treatment Added
Experimental
干预措施: No Treatment Added (Drug)
结局指标
主要结局
Patient Global Impression of Change (PGIC) Responder Rate at End of Study
时间窗: End of Randomized treatment period (11 weeks)
The primary efficacy parameter was the PGIC responder rate, defined as the percentage of patients who rated themselves as "very much improved" or "much improved" (ie, having a score of 1 or 2 on the 7-point scale) for the PGIC at end of study (Visit 6 or Early Termination) compared to Visit 1.
次要结局
- Change From Baseline in Visual Analog Scale (VAS) 1-week Pain Recall at End of Study(Baseline (0 weeks) and End of Randomized Treatment Period (11 weeks))
研究者
研究点 (6)
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