A Phase III, Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Study of Xyrem® in Subjects With Fibromyalgia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 548
- 试验地点
- 69
- 主要终点
- Pain VAS (Visual Analog Scale) Response. Percentage of Subjects With a Greater Than or Equal to 30% Reduction in Pain VAS From Baseline (BOCF).
研究概览
简要总结
The objective of this trial is to evaluate the safety and efficacy of Xyrem® compared to placebo for the treatment of fibromyalgia in a randomized, double blind, placebo controlled, parallel group trial.
详细描述
The trial is a randomized, double blind, placebo controlled, parallel group trial in subjects diagnosed with fibromyalgia in accordance with the American College of Rheumatology. Total duration is up to twenty-one (21) weeks of trial participation. Subjects will undergo a screening and withdrawal/washout period lasting up to five (5) weeks combined, followed by baseline period lasting one (1) week. Total treatment duration will be fourteen (14) weeks followed by one (1) week safety follow-up post treatment period. During the screening and withdrawal/washout period, no study medication will be given; however rescue medication acetaminophen (up to 4 grams per day) will be allowed.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Male or female subjects, 18 years or older who meet the American College of Rheumatology (ACR) diagnostic criteria for fibromyalgia.
排除标准
- •Subjects will be excluded if they have a history of rheumatic disease or other disorders that may compromise reliable representation of subjective symptoms.
- •Any other condition that will cause a risk to subjects if they participate in the trial is also a reason for exclusion.
研究组 & 干预措施
1
干预措施: Placebo (Drug)
2
干预措施: Xyrem® (Drug)
结局指标
主要结局
Pain VAS (Visual Analog Scale) Response. Percentage of Subjects With a Greater Than or Equal to 30% Reduction in Pain VAS From Baseline (BOCF).
时间窗: Baseline to Week 14
Percentage of pain VAS responders. Subjects with a \>= 30% reduction in pain VAS from baseline to endpoint (week 14) were considered responders; all other subjects were considered non-responders. Missing data were handled using BOCF (Baseline Observation Carried Forward). The pain VAS ranges from 0 (no pain) to 100 (worst imaginable pain). The pain VAS was collected morning, afternoon and evening. Baseline is the average value recorded for the measure during the week prior to the end-of-baseline visit. Endpoint is the average value recorded for the measure during the week prior to week 14.
次要结局
未报告次要终点