NCT00830167已完成3 期
Randomized, Double-Blind, Multicenter, Placebo-Controlled Study To Evaluate Efficacy And Safety Of Pregabalin（CI-1008）In 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 498 人开始时间: 2009年3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
- 498
- 试验地点
- 1
- 主要终点
- Change From Baseline for Numerical Rating Scale (NRS) Pain Scores at Endpoint-LOCF (Last Observation Carried Forward) Relative to Baseline
研究概览
简要总结
This study, will compare pregabalin with placebo for the duration of 15 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
- Triple (Participant, Care Provider, Investigator)
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 VAS
- •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
- •Patients with suicidality
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Pregabalin
Experimental
干预措施: Pregabalin (Drug)
结局指标
主要结局
Change From Baseline for Numerical Rating Scale (NRS) Pain Scores at Endpoint-LOCF (Last Observation Carried Forward) Relative to Baseline
时间窗: Baseline, Week 15 or study discontinuation
Change from baseline in mean NRS-Pain scores at endpoint-LOCF. Daily pain scores were assessed on an 11-point numerical rating scale \<(NRS)-Pain\> ranging from 0 (no pain) to 10 (worst possible pain).
次要结局
- Percentage of Participants Who Was Categorized as "Improved (Very Much Improved, Much Improved, or a Minimally Improved)" According to the Patient Global Impressions of Change (PGIC)(Week 15 or study discontinuation)
- Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Snoring(Baseline, Week 15 or study discontinuation)
- Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Awaken Short of Breath or With a Headache(Baseline, Week 15 or study discontinuation)
- Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Somnolence(Baseline, Week 15 or study discontinuation)
- Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Work Miss(Baseline, Week 15 or study discontinuation)
- Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Stiffness(Baseline, Week 15 or study discontinuation)
- Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Role Limitations-Physical(Baseline, Week 15 or study discontinuation)
- Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- General Health Perception(Baseline, Week 15 or study discontinuation)
- Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Sleep Disturbance(Baseline, Week 15 or study discontinuation)
- Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Sleep Adequacy(Baseline, Week 15 or study discontinuation)
- Change From Baseline in Sleep Quality Score at Endpoint(Baseline, Week 15 or study discontinuation)
- Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Total Scores(Baseline, Week 15 or study discontinuation)
- Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Housework(Baseline, Week 15 or study discontinuation)
- Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Tiredness(Baseline, Week 15 or study discontinuation)
- Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Morning(Baseline, Week 15 or study discontinuation)
- Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Depression(Baseline, Week 15 or study discontinuation)
- Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Physical Functioning(Baseline, Week 15 or study discontinuation)
- Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety(Baseline, Week 15 or study discontinuation)
- Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Quantity of Sleep(Baseline, Week 15 or study discontinuation)
- Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Overall Sleep Problems Index(Baseline, Week 15 or study discontinuation)
- Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Physical Function(Baseline, Week 15 or study discontinuation)
- Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Pain(Baseline, Week 15 or study discontinuation)
- Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Bodily Pain(Baseline, Week 15 or study discontinuation)
- Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Vitality(Baseline, Week 15 or study discontinuation)
- Medical Outcomes Study (MOS) Sleep Scale - Number of Participants With Optimal Sleep at Endpoint(Week 15 or study discontinuation)
- Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Role Limitations-Emotional(Baseline, Week 15 or study discontinuation)
- Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Mental Health(Baseline, Week 15 or study discontinuation)
- Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Feel Good(Baseline, Week 15 or study discontinuation)
- Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Anxious(Baseline, Week 15 or study discontinuation)
- Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Social Functioning(Baseline, Week 15 or study discontinuation)
- Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Depression(Baseline, Week 15 or study discontinuation)
- Change From Baseline in Pain Visual Analog Scale (Pain VAS) Score at Endpoint(Baseline, Week 15 or study discontinuation)
研究者
研究点 (1)
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