NCT00830128已完成3 期
An Open-Label Extension Safety And Efficacy Study Of Pregabalin (CI-1008) For The Treatment Of Fibromyalgia
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.1 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2009年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
研究概览
简要总结
This study will assess the safety and efficacy of the long-term use of pregabalin at doses up to 450 mg/day in patients with fibromyalgia who have completed 16 weeks of dosing in Study A0081208 (NCT00830167).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients must have met the inclusion criteria for the preceding fibromyalgia Protocol A0081208, and must have received pregabalin/placebo under double-blind conditions.
排除标准
- •Patients may not participate in the study if they experienced a serious adverse event during the previous fibromyalgia Study A0081208; which was determined to be related to the study medication by the investigator or the sponsor.
研究组 & 干预措施
pregabalin (Lyrica)
Experimental
干预措施: pregabalin (Lyrica) (Drug)
结局指标
主要结局
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: Up to 53 weeks
Any untoward medical occurrence in a participant who received study drug was considered an adverse event (AE), without regard to possibility of causal relationship. Treatment-emergent adverse events: those which occurred or worsened after baseline. An AE resulting in any of the following outcomes, was considered to be a serious adverse event: death; lifethreatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect.
次要结局
- Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Overall Sleep Problems Index at Endpoint(Baseline, Week 52 or Study Discontinuation)
- Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) - Subscale Score at Endpoint(Baseline, Week 52 or Study Discontinuation)
- Change From Baseline in Pain Visual Analog Scale (Pain VAS) Score at Endpoint(Baseline, Week 52 or Study Discontinuation)
- Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Sleep Disturbance at Endpoint(Baseline, Week 52 or Study Discontinuation)
- Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Somnolence at Endpoint(Baseline, Week 52 or Study Discontinuation)
- Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Snoring at Endpoint(Baseline, Week 52 or Study Discontinuation)
- Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Sleep Adequacy at Endpoint(Baseline, Week 52 or Study Discontinuation)
- Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Quantity of Sleep at Endpoint(Baseline, Week 52 or Study Discontinuation)
- Medical Outcomes Study (MOS) Sleep Scale - Optimal Sleep at Endpoint(Week 52 or Study Discontinuation)
- Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Awaken Short of Breath or With a Headache at Endpoint(Baseline, Week 52 or Study Discontinuation)
- Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) - Total Scores at Endpoint(Baseline, Week 52 or Study Discontinuation)
研究者
研究点 (1)
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