NCT00301431终止2 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Adaptive Design, Efficacy and Tolerability Study of 4 Fixed Doses of DVS-233 in Adult Outpatients With Fibromyalgia Syndrome
Wyeth is now a wholly owned subsidiary of Pfizer59 个研究点 分布在 1 个国家目标入组 1,050 人开始时间: 2006年8月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 1,050
- 试验地点
- 59
- 主要终点
- The primary outcome will be the change in the daily pain score from baseline to study day 105 of therapy.
研究概览
简要总结
The purpose of this study is to determine if DVS-233 is safe and effective in the treatment of pain and other symptoms of 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
- •Fibromyalgia according to 1990 American College of Rheumatology (ACR) criteria
排除标准
- •Other painful conditions that may make results difficult to interpret.
- •Treatment with other drugs for fibromyalgia with 14 days of study start or during the study.
结局指标
主要结局
The primary outcome will be the change in the daily pain score from baseline to study day 105 of therapy.
次要结局
- Fibromyalgia Impact Questionnaire and the Patient Global Impression of Change
研究者
研究点 (59)
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