NCT00423605已完成3 期
A Long-Term, Open-Label, Safety and Efficacy Study of Xyrem® (Sodium Oxybate) in Subjects 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
- 入组人数
- 560
- 试验地点
- 91
- 主要终点
- Number of Subjects Reporting Adverse Events
研究概览
简要总结
The objective of this trial is to evaluate the safety and efficacy of Xyrem® in long term use.
详细描述
The trial is an open-label safety and efficacy study of subjects with fibromyalgia who completed either study 06-008 or 06-009. Total duration is up to 40 weeks of trial participation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Subject has qualified for and completed either study 06-009 (NCT00423813) or 06-008 (NCT00371137).
- •Subject is able, in the opinion of the investigator, to take Xyrem® for approximately 9-1/2 months.
排除标准
- •Subject terminated early from either study 06-009 or 06-
- •Subject experienced any serious adverse event related to study drug in either study 06-009 or 06-
- •Subject, in the opinion of the investigator, experienced an adverse event in 06-009 or 06-008 that may prevent him/her from safely participating in this study.
研究组 & 干预措施
1
Experimental
干预措施: Xyrem® (Drug)
结局指标
主要结局
Number of Subjects Reporting Adverse Events
时间窗: Treatment Period (38 weeks)
Number of subjects reporting adverse events.
次要结局
未报告次要终点
研究者
研究点 (91)
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