Fixed Versus Flexible Dosing of Pregabalin in Patients With Fibromyalgia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 174
- 试验地点
- 5
- 主要终点
- Pain score evaluation by NRS
研究概览
简要总结
A 9-week randomized double-blind, multi-center study of 172 patients, who after 1 week baseline evaluation are randomized to either fixed dose pregabalin starting at 75 mg BID for one week and increased to 150 mg BID for 7 weeks or flexibly dosed pregabalin given BID (75-300 mg/d) increased gradually over 4 weeks then maintained at that same dosing for 4 weeks.It is proposed that use of flexible dosing combined with nightly dosing would have similar pain relief to fixed dosing, would improve adherence, would have less side effects and would be more likely to improve sleep.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •diagnosis of fibromyalgia by ACR criteria
- •ambulatory patients
- •complete of 5 pain diaries during 1 week evaluation
- •other inclusion criteria may apply
排除标准
- •pregnant or of childbearing potential not using contraceptives
- •use of pregabalin in the past
- •concomitant use of opioids or gabapentin
- •estimated creatinine clearance less than 60
- •other criteria may apply
研究组 & 干预措施
Flexible Dose
flexibly dosed pregabalin given BID (75-300 mg/d) increased gradually over 4 weeks then maintained at that same dosing for 4 weeks
干预措施: Pregabalin (Drug)
Fixed Dosing
75 mg BID for one week and increased to 150 mg BID for 7 weeks
干预措施: Pregabalin (Drug)
结局指标
主要结局
Pain score evaluation by NRS
时间窗: 8 weeks
Least square mean change in Fibromyalgia pain at 8weeks compared to baseline utilizing an 11 point numerical rating scale daily pain diary (0 = no pain to 10 =worst possible pain) performed at daily awakening.
次要结局
- Patient Global Impression of Change(At weeks 4 and 8)
- Discontinuation rate(9 weeks)
- Improvements in Wolfe Symptom Severity Score(9 weeks)