A Phase 3 Double-Blind, Randomized, Placebo-Controlled, Safety And Efficacy Study Of Once Daily Controlled Release Pregabalin In The Treatment Of Patients With Fibromyalgia (Protocol A0081245)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 290
- 试验地点
- 8
- 主要终点
- Time to loss of therapeutic response based on pain response relative to baseline or patient discontinuation
研究概览
简要总结
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This study is a phase 3 double blind , randomized, placebo controlled trial to evaluate the safety and efficacy of once daily controlled release pregabalin in treatment of patients with fibromyalgia. The starting dose is 165 mg/day and can be escalated at weekly intervals up to 495 mg/day on the basis of efficacy and tolerability. The study will be composed of 4 phases: baseline (1 week), single blind (6 weeks), double-blind treatment (13 weeks), and a 1-week double-blind taper. This study will have 2 arms in the double-blind phase:
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Pregabalin (CR).
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Matching placebo
This study will use a randomized withdrawal (RW) trial design. The RW design includes 2 phases: a single-blind pregabalin treatment phase and a double-blind randomized withdrawal phase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients must have fibromyalgia.
排除标准
- •Patients with other painful conditions cannot participate.
结局指标
主要结局
Time to loss of therapeutic response based on pain response relative to baseline or patient discontinuation
时间窗: 19 weeks
次要结局
- 1.Daily pain diary(throughout study)
- 2.Daily tiredness diary(throughout study)
- 3.Daily sleep diary(throughout study)
- 4.Numeric rating scale for pain(screening, baseline, 6 and 19 weeks)
- 5.Medical outcomes sleep study-sleep scale(baseline, 6 and 19 weeks)
- 6.Patient global impression of change(baseline, 6 and 19 weeks)
- 7.Short form 36 health survey (SF-36)(baseline, 6 and 19 weeks)
- 8.Hospital anxiety and depression scale(baseline, 6 and 19 weeks)
- 9.Fibromyalgia impact questionnaire(baseline, 6 and 19 weeks)
- 10.Multidimensional fatigue instrument(baseline, 6 and 19 weeks)
- 11.Benefit, satisfaction, willingness to continue measure(baseline, 6 and 19 weeks)
- 12.Work productivity and activity impairment(baseline, 6 and 19 weeks)
- 13.Actigraphy functional / sleep assessment(screening, 3 and 11 weeks)
- 14.Adverse events, suicidality assessment(throughout study)
- 15.Clinical laboratory tests, ECG, physical / neurological examinations, weight assessment, and vital signs(screening, 6 and 19 weeks)