The Efficacy and Safety of Pregabalin Release Tablets for the Treatment of Fibromyalgia
试验速览
- 阶段
- 3 期
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Change from baseline in mean pain score diary at Endpoint
研究概览
简要总结
The purpose of this study is to evaluate the Efficacy and safety of pregabalin sustained release tablets versus placebo for fibromyalgia
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who met the 1990 American College of Rheumatology (ACR) criteria for fibromyalgia (ie, widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites).
- •Patients who completed at least 4 pain diaries within the last 7 days and the average pain score must have been ≥4, and had a score of ≥40 mm on the Visual Analogue Scale (VAS) at screening and randomization .
排除标准
- •Patients with other severe pain that may confound assessment or self-evaluation of the pain associated with fibromyalgia.
- •Patients with any inflammatory muscle or rheumatologic disease other than fibromyalgia, active infections, or untreated endocrine disorders.
研究组 & 干预措施
330mg/day
330 mg QD taken orally,1 pills once ,one time a day in an hour after meals, oral administration for 15 weeks (3 week titration and 12-week fixed dose)
干预措施: Pregabalin Release Tablets (Drug)
495mg/day
495 mg QD taken orally,2 pills once ,one time a day in an hour after meals, oral administration for 15 weeks (3 week titration and 12-week fixed dose)
干预措施: Pregabalin Release Tablets (Drug)
Placebo
1 or 2 pills once ,one time a day in an hour after meals, oral administration for 15 weeks (3 week titration and 12-week fixed dose)
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in mean pain score diary at Endpoint
时间窗: Baseline and 15 weeks
derived from the subject's daily pain
次要结局
- Quality of Sleep Score from the Daily Sleep Diary(up to 15 weeks)
- Mean pain score from the subject's daily pain(up to 15 weeks)
- Change from baseline in FIQ scores at Weeks 15(Baseline and Weeks 15)
- Change from baseline in HADS scores at Weeks 15(Baseline and Weeks 15)
- Change from baseline in SF-36 scores at Weeks 15(Baseline and Weeks 15)
- Change from baseline in MOS-SS scores at Weeks 15(Baseline and Weeks 15)