A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Pregabalin-Referenced, Parallel-Group, Adaptive Design Study of DVS SR in Adult Female Outpatients With Fibromyalgia Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 125
- 主要终点
- Change From Baseline on the Numeric Rating Scale (NRS)
研究概览
简要总结
The purpose of this study is to evaluate if DVS SR is safe and effective in the treatment of pain associated with fibromyalgia syndrome, and if so to identify the efficacious doses.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Fibromyalgia diagnosed according to 1990 American College of Rheumatology criteria
排除标准
- •Unstable medical or psychological conditions that would compromise the subject's safety or put the subject at greater risk during study participation
- •Other painful conditions that may confound the diagnosis or assessment of fibromyalgia
- •Treatment with other drugs for fibromyalgia with 14 days of study start or during the study
研究组 & 干预措施
Placebo
In the first stage, subjects were randomly assigned to receive placebo. Study was stopped after stage 1 by sponsor.
干预措施: Placebo (Drug)
DVS SR
In the first stage, subjects were randomly assigned to receive DVS SR 200 mg/day. Study was stopped after stage 1 by sponsor.
干预措施: Desvenlafaxine Sustained Release (DVS SR) (Drug)
Pregabalin
In the first stage, subjects were randomly assigned to receive Pregabalin 450 mg/day. Study was stopped after stage 1 by sponsor.
干预措施: Lyrica® (Pregabalin) (Drug)
结局指标
主要结局
Change From Baseline on the Numeric Rating Scale (NRS)
时间窗: Baseline and 8 weeks
The primary efficacy variable was the change from baseline on the NRS. The primary time point was the average pain score during the last data-analysis-interval of week 8. The baseline score was the average of the NRS scores across the last 7 days of the screening period (just prior to the start of the placebo run-in). The primary efficacy variable was the pain severity score measured on an 11 point NRS on which 0=no pain and 10=worst possible pain.
次要结局
- Change From Baseline on the Numeric Rating Scale (NRS) in the Treatment of Pain Associated With Fibromyalgia in Adult Female Outpatients(Baseline and 8 weeks)