A 14 Week, Randomized, Double-Blind, Placebo-Controlled Trial Of Pregabalin Twice Daily In Patients With Fibromyalgia.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 747
- 试验地点
- 1
- 主要终点
- Patient Global Impression of Change (PGIC)
研究概览
简要总结
This study, will compare pregabalin with placebo for the duration of 14 weeks to evaluate the efficacy and safety of pregabalin in patients with 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
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ACR criteria for fibromyalgia
- •A score of more or equal to 40 mm on the Pain Visual Analog Scale (VAS) and a an average score more or equal to 4 on 4 daily pain diaries
排除标准
- •Patients with other severe pain conditions
- •Patients with severe depression
- •Patients taking excluded medications
研究组 & 干预措施
1
干预措施: pregabalin (Drug)
2
干预措施: pregabalin (Drug)
3
干预措施: pregabalin (Drug)
4
干预措施: placebo (Drug)
结局指标
主要结局
Patient Global Impression of Change (PGIC)
时间窗: Week 14
Number of participants with categorical change in overall status. PGIC: a participant-rated instrument assessing change in participant's overall status from baseline, on a scale ranging from 1 (very much improved) to 7 (very much worse).
Change From Baseline in Mean Pain Score at Endpoint (Up to Week 14)
时间窗: Baseline, Week 14
Daily pain diary consists of 11-point NRS ranging from 0(no pain) to 10(worst possible pain). Participants rated their pain during past 24 hours, self-assessment done daily at awakening. Baseline=Last 7 available pain scores before taking study medication up to and including Day 1. Final weekly (endpoint) mean pain score is defined as the mean pain score from the last 7 pain diary entries in the study while the participant was on study medication.
次要结局
- Change From Baseline in Weekly Mean Sleep Quality Score(Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14)
- Percentage of Participants With Optimal Sleep Assessed Using MOS-SS(Baseline, Week 14)
- Change From Baseline in Medical Outcomes Study (MOS): Sub-scales at Week 14(Baseline, Week 14)
- Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Scores at Week 14(Baseline, Week 14)
- Change From Baseline in Mean Sleep Quality Score at Endpoint (Up to Week 14)(Baseline, Week 14)
- Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Subscale Scores at Week 14(Baseline, Week 14)
- Change From Baseline in Multidimensional Assessment of Fatigue (MAF) at Week 14(Baseline, Week 14)
- Change From Baseline in Short Form-36 (SF-36) Health Survey at Week 14(Baseline, Week 14)
- Change From Baseline in Hospital Anxiety and Depression Scale (HADS) at Week 14(Baseline, Week 14)
- Change From Baseline in Pain Visual Analogue Scale (VAS) Scores at Week 14(Baseline, Week 14)
- Total Daily Acetaminophen Dose(Week 14)