Safety and Efficacy of AGN 203818 for Pain Associated With Fibromyalgia Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Allergan
- 入组人数
- 211
- 主要终点
- Change From Baseline in Mean Daily-Average-Pain Score at Week 4
研究概览
简要总结
This study will explore the safety and effectiveness of different doses of AGN 203818 in treating the pain associated with fibromyalgia syndrome. The study is being conducted in 2 parts. Part A enrolled 211 pts dosed with either 3, 20, 60 mg BID AGN 203818 or placebo over 4 week treatment duration. Part B will enroll 440 pts and dose with either 20, 100, 160 mg BID AGN 203818 or placebo over 12 week treatment duration.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of fibromyalgia syndrome
- •Moderate or severe pain associated with fibromyalgia
排除标准
- •Any other uncontrolled disease
- •Pregnant or nursing females
研究组 & 干预措施
Placebo
Part A: Placebo every 12 hours for 4 weeks
干预措施: placebo (Drug)
AGN 203818 3 mg
Part A: 3 mg AGN 203818 every 12 hours for 4 weeks
干预措施: AGN 203818 (Drug)
AGN 203818 20 mg
Part A: 20 mg AGN 203818 every 12 hours for 4 weeks
干预措施: AGN 203818 (Drug)
AGN 203818 60 mg
Part A: 60 mg AGN 203818 every 12 hours for 4 weeks
干预措施: AGN 203818 (Drug)
结局指标
主要结局
Change From Baseline in Mean Daily-Average-Pain Score at Week 4
时间窗: Baseline, Week 4
Change from Baseline in mean daily-average-pain score at week 4. Patients recorded their daily average pain on a 11-point scale (where 0 equals no pain and 10 equals worst pain imaginable) using a diary during the 4-week treatment period. A negative number change from baseline represents a decrease in average pain (improvement).
次要结局
- Change From Baseline in the Short Form Brief Pain Inventory (SF-BPI) Average Pain Score at Week 4(Baseline, Week 4)
- Change From Baseline in the Fibromyalgia Impact Questionnaire (FIQ) Total Score of Physical Impairment at Week 4(Baseline, Week 4)
- Patient Global Impression of Change (PGIC) for Fibromyalgia Syndrome Status at Week 4(Week 4)